Trial Outcomes & Findings for Evaluation of Safety, Tolerability, Pharmacokinetics, Drug-Drug and Food Interactions of Single and Multiple Doses of S-648414 in Healthy Adults (NCT NCT04147715)

NCT ID: NCT04147715

Last Updated: 2021-11-01

Results Overview

A TEAE is any event not present before exposure to study drug or any event already present that worsens after exposure to study drug. A serious adverse event is any untoward medical occurrence that resulted in death, was life-threatening, required or prolonged inpatient hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or other event that may have jeopardized the participant or required intervention to prevent one of the outcomes above. The investigator assessed the intensity of each AE according to the following: Grade 1 (Mild): No or minimal interference with usual activities. Grade 2 (Moderate): More than minimal interference with usual activities, intervention indicated. Grade 3 (Severe): Inability to perform usual activities, intervention or hospitalization indicated. Grade 4 (Potentially life-threatening): Inability to perform self-care, intervention indicated to prevent permanent impairment, disability, or death.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 98 participants
• Primary outcome timeframe: From dosing on Day 1 or Day 14 up to 10 days post dose
• Results posted on: 2021-11-01

Participant Flow

The study consisted of Part 1 (single ascending dose [SAD], food effect, and effects on electrocardiogram [ECG] parameters), Part 2 (multiple ascending dose [MAD] and drug-drug interaction with midazolam, a CYP3A substrate), and Part 3 (the effect of S-648414 on the pharmacokinetics (PK) of dolutegravir and the effect of dolutegravir on the PK of S-648414). Parts 1 and 2 were conducted at a single site in the United States, and Part 3 was conducted at a single site in Japan.

In Part 1 healthy participants were sequentially assigned to 1 of 6 ascending dose groups; within each dose group participants were randomized in a 3:1 ratio (4:1 in the 100 mg dose group) to receive S-648414 or placebo. In Part 2 healthy participants were assigned to 1 of 2 dose groups with 8 study participants randomized to receive S-648414 and 2 study participants receiving placebo per group. In Part 3 healthy participants were enrolled in 1 of 2 dose groups.

Participant milestones

Measure	Part 1: Placebo Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1. Two participants assigned to the 100 mg dose cohort also received a single oral dose of matching placebo in a fed state (after a high-fat meal) on Day 14.	Part 1: 10 mg S-648414 Participants received a single oral dose of 10 mg S-648414 in a fasted state on Day 1.	Part 1: 30 mg S-648414 Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1 followed by a single dose of S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.	Part 2: Placebo + Midazolam Participants received matching placebo to S-648414 once a day on Days 1 to 14 and a single oral dose of 5 mg midazolam alone on Day -2 and co-administered with the placebo dose on Day 14.	Part 2: 50 mg S-648414 + Midazolam Participants received 50 mg S-648414 once a day on Days 1 to 14 and a single oral dose of 5 mg midazolam alone on Day -2 and co-administered with the S-648414 dose on Day 14.	Part 2: 30 mg S-648414 + Midazolam Participants received 30 mg S-648414 once a day on Days 1 to 14 and a single oral dose of 5 mg midazolam alone on Day -2 and co-administered with the S-648414 dose on Day 14.	Part 3: 100 mg S-648414 + Dolutegravir Participants received 50 mg dolutegravir orally once a day on Days 1 to 7, 100 mg S-648414 orally once a day on Days 15 to 21, and 50 mg dolutegravir co-administered with 100 mg S-648414 orally once a day on Days 22 to 28.	Part 3: 200 mg S-648414 + Dolutegravir Participants received 50 mg dolutegravir orally once a day on Days 1 to 7, 200 mg S-648414 orally once a day on Days 15 to 21, and 50 mg dolutegravir co-administered with 200 mg S-648414 orally once a day on Days 22 to 28.
Overall Study STARTED	12	6	6	8	6	6	6	4	8	8	14	14
Overall Study COMPLETED	12	6	6	8	6	6	6	2	7	8	14	14
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	2	1	0	0	0

Reasons for withdrawal

Measure	Part 1: Placebo Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1. Two participants assigned to the 100 mg dose cohort also received a single oral dose of matching placebo in a fed state (after a high-fat meal) on Day 14.	Part 1: 10 mg S-648414 Participants received a single oral dose of 10 mg S-648414 in a fasted state on Day 1.	Part 1: 30 mg S-648414 Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1 followed by a single dose of S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.	Part 2: Placebo + Midazolam Participants received matching placebo to S-648414 once a day on Days 1 to 14 and a single oral dose of 5 mg midazolam alone on Day -2 and co-administered with the placebo dose on Day 14.	Part 2: 50 mg S-648414 + Midazolam Participants received 50 mg S-648414 once a day on Days 1 to 14 and a single oral dose of 5 mg midazolam alone on Day -2 and co-administered with the S-648414 dose on Day 14.	Part 2: 30 mg S-648414 + Midazolam Participants received 30 mg S-648414 once a day on Days 1 to 14 and a single oral dose of 5 mg midazolam alone on Day -2 and co-administered with the S-648414 dose on Day 14.	Part 3: 100 mg S-648414 + Dolutegravir Participants received 50 mg dolutegravir orally once a day on Days 1 to 7, 100 mg S-648414 orally once a day on Days 15 to 21, and 50 mg dolutegravir co-administered with 100 mg S-648414 orally once a day on Days 22 to 28.	Part 3: 200 mg S-648414 + Dolutegravir Participants received 50 mg dolutegravir orally once a day on Days 1 to 7, 200 mg S-648414 orally once a day on Days 15 to 21, and 50 mg dolutegravir co-administered with 200 mg S-648414 orally once a day on Days 22 to 28.
Overall Study Adverse Event	0	0	0	0	0	0	0	2	1	0	0	0

Baseline Characteristics

Age data are reported separately for each part of the study.

Baseline characteristics by cohort

Measure	Part 1: Placebo n=12 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1. Two participants assigned to the 100 mg dose cohort also received a single oral dose of matching placebo in a fed state (after a high-fat meal) on Day 14.	Part 1: 10 mg S-648414 n=6 Participants Participants received a single oral dose of 10 mg S-648414 in a fasted state on Day 1.	Part 1: 30 mg S-648414 n=6 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 n=8 Participants Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1 followed by a single dose of S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 n=6 Participants Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 n=6 Participants Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 n=6 Participants Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.	Part 2: Placebo + Midazolam n=4 Participants Participants received matching placebo to S-648414 once a day on Days 1 to 14 and a single oral dose of 5 mg midazolam alone on Day -2 and co-administered with the placebo dose on Day 14.	Part 2: 50 mg S-648414 + Midazolam n=8 Participants Participants received 50 mg S-648414 once a day on Days 1 to 14 and a single oral dose of 5 mg midazolam alone on Day -2 and co-administered with the S-648414 dose on Day 14.	Part 2: 30 mg S-648414 + Midazolam n=8 Participants Participants received 30 mg S-648414 once a day on Days 1 to 14 and a single oral dose of 5 mg midazolam alone on Day -2 and co-administered with the S-648414 dose on Day 14.	Part 3: 100 mg S-648414 + Dolutegravir n=14 Participants Participants received 50 mg dolutegravir orally once a day on Days 1 to 7, 100 mg S-648414 orally once a day on Days 15 to 21, and 50 mg dolutegravir co-administered with 100 mg S-648414 orally once a day on Days 22 to 28.	Part 3: 200 mg S-648414 + Dolutegravir n=14 Participants Participants received 50 mg dolutegravir orally once a day on Days 1 to 7, 200 mg S-648414 orally once a day on Days 15 to 21, and 50 mg dolutegravir co-administered with 200 mg S-648414 orally once a day on Days 22 to 28.	Total n=98 Participants Total of all reporting groups
Race/Ethnicity, Customized White	6 Participants n=12 Participants	3 Participants n=6 Participants	4 Participants n=6 Participants	5 Participants n=8 Participants	2 Participants n=6 Participants	4 Participants n=6 Participants	4 Participants n=6 Participants	2 Participants n=4 Participants	5 Participants n=8 Participants	3 Participants n=8 Participants	12 Participants n=14 Participants	8 Participants n=14 Participants	58 Participants n=98 Participants
Race/Ethnicity, Customized Other	0 Participants n=12 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=14 Participants	0 Participants n=14 Participants	0 Participants n=98 Participants
Age, Continuous Part 1	33.3 years STANDARD_DEVIATION 8.53 • n=12 Participants • Age data are reported separately for each part of the study.	38.0 years STANDARD_DEVIATION 10.55 • n=6 Participants • Age data are reported separately for each part of the study.	40.3 years STANDARD_DEVIATION 8.98 • n=6 Participants • Age data are reported separately for each part of the study.	35.5 years STANDARD_DEVIATION 7.80 • n=8 Participants • Age data are reported separately for each part of the study.	28.5 years STANDARD_DEVIATION 5.68 • n=6 Participants • Age data are reported separately for each part of the study.	32.5 years STANDARD_DEVIATION 14.87 • n=6 Participants • Age data are reported separately for each part of the study.	36.5 years STANDARD_DEVIATION 11.22 • n=6 Participants • Age data are reported separately for each part of the study.	—	—	—	—	—	34.8 years STANDARD_DEVIATION 9.74 • n=50 Participants • Age data are reported separately for each part of the study.
Age, Continuous Part 2	—	—	—	—	—	—	—	36.0 years STANDARD_DEVIATION 10.03 • n=4 Participants • Age data are reported separately for each part of the study.	37.3 years STANDARD_DEVIATION 9.97 • n=8 Participants • Age data are reported separately for each part of the study.	34.4 years STANDARD_DEVIATION 7.03 • n=8 Participants • Age data are reported separately for each part of the study.	—	—	35.9 years STANDARD_DEVIATION 8.51 • n=20 Participants • Age data are reported separately for each part of the study.
Age, Continuous Part 3	—	—	—	—	—	—	—	—	—	—	35.4 years STANDARD_DEVIATION 6.70 • n=14 Participants • Age data are reported separately for each part of the study.	34.9 years STANDARD_DEVIATION 6.32 • n=14 Participants • Age data are reported separately for each part of the study.	35.1 years STANDARD_DEVIATION 6.40 • n=28 Participants • Age data are reported separately for each part of the study.
Sex: Female, Male Female	0 Participants n=12 Participants	1 Participants n=6 Participants	1 Participants n=6 Participants	1 Participants n=8 Participants	0 Participants n=6 Participants	2 Participants n=6 Participants	1 Participants n=6 Participants	1 Participants n=4 Participants	2 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=14 Participants	0 Participants n=14 Participants	10 Participants n=98 Participants
Sex: Female, Male Male	12 Participants n=12 Participants	5 Participants n=6 Participants	5 Participants n=6 Participants	7 Participants n=8 Participants	6 Participants n=6 Participants	4 Participants n=6 Participants	5 Participants n=6 Participants	3 Participants n=4 Participants	6 Participants n=8 Participants	7 Participants n=8 Participants	14 Participants n=14 Participants	14 Participants n=14 Participants	88 Participants n=98 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=12 Participants	1 Participants n=6 Participants	3 Participants n=6 Participants	4 Participants n=8 Participants	1 Participants n=6 Participants	2 Participants n=6 Participants	3 Participants n=6 Participants	0 Participants n=4 Participants	3 Participants n=8 Participants	3 Participants n=8 Participants	2 Participants n=14 Participants	0 Participants n=14 Participants	27 Participants n=98 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=12 Participants	5 Participants n=6 Participants	3 Participants n=6 Participants	4 Participants n=8 Participants	5 Participants n=6 Participants	4 Participants n=6 Participants	3 Participants n=6 Participants	4 Participants n=4 Participants	5 Participants n=8 Participants	5 Participants n=8 Participants	12 Participants n=14 Participants	14 Participants n=14 Participants	71 Participants n=98 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=12 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=14 Participants	0 Participants n=14 Participants	0 Participants n=98 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=12 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=14 Participants	0 Participants n=14 Participants	0 Participants n=98 Participants
Race/Ethnicity, Customized Asian	1 Participants n=12 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=14 Participants	0 Participants n=14 Participants	1 Participants n=98 Participants
Race/Ethnicity, Customized Black or African American	5 Participants n=12 Participants	3 Participants n=6 Participants	2 Participants n=6 Participants	3 Participants n=8 Participants	4 Participants n=6 Participants	2 Participants n=6 Participants	2 Participants n=6 Participants	2 Participants n=4 Participants	3 Participants n=8 Participants	5 Participants n=8 Participants	2 Participants n=14 Participants	6 Participants n=14 Participants	39 Participants n=98 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=12 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=14 Participants	0 Participants n=14 Participants	0 Participants n=98 Participants

PRIMARY outcome

Timeframe: From dosing on Day 1 or Day 14 up to 10 days post dose

Population: The safety analysis population included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.

A TEAE is any event not present before exposure to study drug or any event already present that worsens after exposure to study drug.

A serious adverse event is any untoward medical occurrence that resulted in death, was life-threatening, required or prolonged inpatient hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or other event that may have jeopardized the participant or required intervention to prevent one of the outcomes above.

The investigator assessed the intensity of each AE according to the following:

Grade 1 (Mild): No or minimal interference with usual activities.

Grade 2 (Moderate): More than minimal interference with usual activities, intervention indicated.

Grade 3 (Severe): Inability to perform usual activities, intervention or hospitalization indicated.

Grade 4 (Potentially life-threatening): Inability to perform self-care, intervention indicated to prevent permanent impairment, disability, or death.

Outcome measures

Measure	Part 3: 200 mg S-648414 n=6 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=12 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=2 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=6 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted n=8 Participants Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed n=8 Participants Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 n=6 Participants Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 n=6 Participants Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 n=6 Participants Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Any gastrointestinal AEs	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	2 Participants
Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Any ocular AEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Serious adverse events (SAEs)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Any treatment-related SAE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Any TEAE leading to study discontinuation	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Any TEAE leading to study drug discontinuation	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Deaths	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Any treatment-emergent adverse event (TEAE)	0 Participants	2 Participants	0 Participants	1 Participants	2 Participants	2 Participants	1 Participants	1 Participants	2 Participants
Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Any treatment-related TEAE	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	2 Participants
Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Any TEAE with severity Grade 2 to 4	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Any TEAE with severity Grade 3 to 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From the first dose up to 10 days after end of dosing (25 days); A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.

Population: The safety analysis population included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.

A TEAE is any event not present before exposure to study drug or any event already present that worsens after exposure to study drug.

A serious adverse event is any untoward medical occurrence that resulted in death, was life-threatening, required or prolonged inpatient hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or other event that may have jeopardized the participant or required intervention to prevent one of the outcomes above.

The investigator assessed the intensity of each AE according to the following:

Grade 1 (Mild): No or minimal interference with usual activities.

Grade 2 (Moderate): More than minimal interference with usual activities, intervention indicated.

Grade 3 (Severe): Inability to perform usual activities, intervention or hospitalization indicated.

Grade 4 (Potentially life-threatening): Inability to perform self-care, intervention indicated to prevent permanent impairment, disability, or death.

Outcome measures

Measure	Part 3: 200 mg S-648414 n=8 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=20 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=4 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=8 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted n=2 Participants Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed n=7 Participants Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 n=8 Participants Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 2: Number of Participants With Treatment-emergent Adverse Events Any TEAE	2 Participants	0 Participants	2 Participants	3 Participants	0 Participants	1 Participants	1 Participants	—	—
Part 2: Number of Participants With Treatment-emergent Adverse Events Any treatment-related TEAE	2 Participants	0 Participants	2 Participants	2 Participants	0 Participants	1 Participants	0 Participants	—	—
Part 2: Number of Participants With Treatment-emergent Adverse Events Any TEAE with severity Grade 2 to 4	2 Participants	0 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—	—
Part 2: Number of Participants With Treatment-emergent Adverse Events Any TEAE with severity Grade 3 to 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Part 2: Number of Participants With Treatment-emergent Adverse Events Any gastrointestinal AEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Part 2: Number of Participants With Treatment-emergent Adverse Events Any ocular AEs	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants	—	—
Part 2: Number of Participants With Treatment-emergent Adverse Events Any serious adverse events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Part 2: Number of Participants With Treatment-emergent Adverse Events Any treatment-related SAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Part 2: Number of Participants With Treatment-emergent Adverse Events Any TEAE leading to study discontinuation	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Part 2: Number of Participants With Treatment-emergent Adverse Events Any TEAE leading to study drug discontinuation	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Part 2: Number of Participants With Treatment-emergent Adverse Events Deaths	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—

PRIMARY outcome

Timeframe: From the first dose up to Day 36; A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.

Population: The safety analysis population included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.

A TEAE is any event not present before exposure to study drug or any event already present that worsens after exposure to study drug.

A serious adverse event is any untoward medical occurrence that resulted in death, was life-threatening, required or prolonged inpatient hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or other event that may have jeopardized the participant or required intervention to prevent one of the outcomes above.

The investigator assessed the intensity of each AE according to the following:

Grade 1 (Mild): No or minimal interference with usual activities.

Grade 2 (Moderate): More than minimal interference with usual activities, intervention indicated.

Grade 3 (Severe): Inability to perform usual activities, intervention or hospitalization indicated.

Grade 4 (Potentially life-threatening): Inability to perform self-care, intervention indicated to prevent permanent impairment, disability, or death.

Outcome measures

Measure	Part 3: 200 mg S-648414 n=14 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=14 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=14 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=14 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted n=14 Participants Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed n=14 Participants Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 3: Number of Participants With Treatment-emergent Adverse Events Any TEAE	4 Participants	3 Participants	3 Participants	2 Participants	5 Participants	2 Participants	—	—	—
Part 3: Number of Participants With Treatment-emergent Adverse Events Any treatment-related TEAE	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	—	—	—
Part 3: Number of Participants With Treatment-emergent Adverse Events Any TEAE with severity Grade 2 to 4	2 Participants	2 Participants	2 Participants	2 Participants	3 Participants	1 Participants	—	—	—
Part 3: Number of Participants With Treatment-emergent Adverse Events Any TEAE with severity Grade 3 to 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Part 3: Number of Participants With Treatment-emergent Adverse Events Any gastrointestinal AEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—
Part 3: Number of Participants With Treatment-emergent Adverse Events Any ocular AEs	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	—	—	—
Part 3: Number of Participants With Treatment-emergent Adverse Events Any serious adverse events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Part 3: Number of Participants With Treatment-emergent Adverse Events Any treatment-related SAE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Part 3: Number of Participants With Treatment-emergent Adverse Events Any TEAE leading to study discontinuation	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Part 3: Number of Participants With Treatment-emergent Adverse Events Any TEAE leading to study drug discontinuation	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Part 3: Number of Participants With Treatment-emergent Adverse Events Deaths	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—

PRIMARY outcome

Timeframe: Day 21 predose (0 hours), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 and 12 hours postdose. Day 28 predose (0 hours), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours postdose.

Population: The PK parameter population includes all study participants with at least 1 PK parameter estimated appropriately.

The effect of dolutegravir on the pharmacokinetics (PK) of S-648414 was assessed after administration of multiple oral doses of S-648414 alone (Day 21) and after administration of multiple oral doses of S-648414 co-administered with dolutegravir (Day 28).

Outcome measures

Measure	Part 3: 200 mg S-648414 n=14 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=14 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=14 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=14 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 3: Maximum Plasma Concentration (Cmax) of S-648414	5150 ng/mL Geometric Coefficient of Variation 14.1	2740 ng/mL Geometric Coefficient of Variation 20.3	2720 ng/mL Geometric Coefficient of Variation 21.3	5020 ng/mL Geometric Coefficient of Variation 15.3	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 21 predose (0 hours), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 and 12 hours postdose. Day 28 predose (0 hours), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours postdose.

Population: The PK parameter population

The effect of dolutegravir on the pharmacokinetics (PK) of S-648414 was assessed after administration of multiple oral doses of S-648414 alone (Day 21) and after administration of multiple oral doses of S-648414 co-administered with dolutegravir (Day 28).

Outcome measures

Measure	Part 3: 200 mg S-648414 n=14 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=14 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=14 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=14 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 3: Time to Maximum Plasma Concentration (Tmax) of S-648414	2.50 hours Interval 1.0 to 4.0	2.00 hours Interval 1.0 to 4.0	2.25 hours Interval 1.0 to 5.0	2.25 hours Interval 1.0 to 5.0	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 22 and Day 29 (24 hours post-dosing on Days 21 and 28)

Population: The PK parameter population

The effect of dolutegravir on the pharmacokinetics (PK) of S-648414 was assessed after administration of multiple oral doses of S-648414 alone (Day 21) and after administration of multiple oral doses of S-648414 co-administered with dolutegravir (Day 28).

Outcome measures

Measure	Part 3: 200 mg S-648414 n=14 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=14 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=14 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=14 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 3: Plasma Concentration of S-648414 at the End of the Dosing Interval τ (Cτ)	2590 ng/mL Geometric Coefficient of Variation 16.5	1210 ng/mL Geometric Coefficient of Variation 27.7	1250 ng/mL Geometric Coefficient of Variation 16.3	2360 ng/mL Geometric Coefficient of Variation 14.5	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 21 predose (0 hours), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 and 12 hours postdose. Day 28 predose (0 hours), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours postdose.

Population: The PK parameter population

The effect of dolutegravir on the pharmacokinetics (PK) of S-648414 was assessed after administration of multiple oral doses of S-648414 alone (Day 21) and after administration of multiple oral doses of S-648414 co-administered with dolutegravir (Day 28).

Area under the concentration-time curve over the dosing interval τ (24 hours) was calculated by the linear up/log down trapezoidal method.

Outcome measures

Measure	Part 3: 200 mg S-648414 n=14 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=14 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=14 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=14 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 3: Area Under the Concentration-time Curve Over the Dosing Interval τ (AUC0-τ) for S-648414	81010 ng*hr/mL Geometric Coefficient of Variation 11.4	40800 ng*hr/mL Geometric Coefficient of Variation 17.6	41080 ng*hr/mL Geometric Coefficient of Variation 15.4	79820 ng*hr/mL Geometric Coefficient of Variation 12.5	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 21 predose (0 hours), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 and 12 hours postdose. Day 28 predose (0 hours), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours postdose.

Population: The PK parameter population

The effect of dolutegravir on the pharmacokinetics (PK) of S-648414 was assessed after administration of multiple oral doses of S-648414 alone (Day 21) and after administration of multiple oral doses of S-648414 co-administered with dolutegravir (Day 28).

Apparent total clearance was calculated as CL/F = Dose/AUC0-τ

Outcome measures

Measure	Part 3: 200 mg S-648414 n=14 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=14 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=14 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=14 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 3: Apparent Total Clearance (CL/F) of S-648414	2.47 L/hr Geometric Coefficient of Variation 11.4	2.45 L/hr Geometric Coefficient of Variation 17.6	2.43 L/hr Geometric Coefficient of Variation 15.4	2.51 L/hr Geometric Coefficient of Variation 12.5	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 7 and Day 28 predose (0 hours), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours postdose.

Population: The PK parameter population

The effect of S-648414 on the PK of dolutegravir was assessed after administration of multiple oral doses of dolutegravir alone and after administration of multiple oral doses of S-648414 co-administered with dolutegravir.

Outcome measures

Measure	Part 3: 200 mg S-648414 n=14 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=14 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=14 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=14 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 3: Maximum Plasma Concentration (Cmax) of Dolutegravir	4720 ng/mL Geometric Coefficient of Variation 19.6	4910 ng/mL Geometric Coefficient of Variation 15.9	5800 ng/mL Geometric Coefficient of Variation 12.2	4950 ng/mL Geometric Coefficient of Variation 15.9	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 7 and Day 28 predose (0 hours), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours postdose.

Population: The PK parameter population

The effect of S-648414 on the PK of dolutegravir was assessed after administration of multiple oral doses of dolutegravir alone and after administration of multiple oral doses of S-648414 co-administered with dolutegravir.

Outcome measures

Measure	Part 3: 200 mg S-648414 n=14 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=14 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=14 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=14 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 3: Time to Maximum Plasma Concentration (Tmax) of Dolutegravir	3.50 hours Interval 1.0 to 5.0	3.50 hours Interval 1.5 to 4.0	2.75 hours Interval 1.0 to 4.0	4.00 hours Interval 1.5 to 5.0	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 8 and Day 29 (24 hours post-dosing on Day 7 and Day 28).

Population: The PK parameter population

The effect of S-648414 on the PK of dolutegravir was assessed after administration of multiple oral doses of dolutegravir alone and after administration of multiple oral doses of S-648414 co-administered with dolutegravir.

Outcome measures

Measure	Part 3: 200 mg S-648414 n=14 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=14 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=14 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=14 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 3: Plasma Concentration of Dolutegravir at the End of the Dosing Interval τ (Cτ)	1850 ng/mL Geometric Coefficient of Variation 25.7	1980 ng/mL Geometric Coefficient of Variation 23.1	2660 ng/mL Geometric Coefficient of Variation 17.6	2000 ng/mL Geometric Coefficient of Variation 23.9	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 7 and Day 28 predose (0 hours), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours postdose.

Population: The PK parameter population

The effect of S-648414 on the PK of dolutegravir was assessed after administration of multiple oral doses of dolutegravir alone and after administration of multiple oral doses of S-648414 co-administered with dolutegravir.

Area under the concentration-time curve over the dosing interval τ (24 hours) was calculated by the linear up/log down trapezoidal method.

Outcome measures

Measure	Part 3: 200 mg S-648414 n=14 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=14 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=14 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=14 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 3: Area Under the Concentration-time Curve Over the Dosing Interval τ (AUC0-τ) for Dolutegravir	69850 ng*hr/mL Geometric Coefficient of Variation 20.1	74790 ng*hr/mL Geometric Coefficient of Variation 19.7	89290 ng*hr/mL Geometric Coefficient of Variation 13.4	73210 ng*hr/mL Geometric Coefficient of Variation 17.6	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 7 and Day 28 predose (0 hours), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours postdose.

Population: The PK parameter population

The effect of S-648414 on the PK of dolutegravir was assessed after administration of multiple oral doses of dolutegravir alone and after administration of multiple oral doses of S-648414 co-administered with dolutegravir.

Apparent total clearance calculated as CL/F =Dose/AUC0-τ

Outcome measures

Measure	Part 3: 200 mg S-648414 n=14 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=14 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=14 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=14 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 3: Apparent Total Clearance (CL/F) of Dolutegravir	0.716 L/hr Geometric Coefficient of Variation 20.1	0.669 L/hr Geometric Coefficient of Variation 19.7	0.560 L/hr Geometric Coefficient of Variation 13.4	0.683 L/hr Geometric Coefficient of Variation 17.6	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 and Day 14 (for participants in the 100 mg dose group only) predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours postdose.

Population: The PK parameter population

Outcome measures

Measure	Part 3: 200 mg S-648414 n=8 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=6 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=6 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=8 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted n=6 Participants Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed n=6 Participants Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 n=6 Participants Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 1: Maximum Plasma Concentration (Cmax) of S-648414	1620 ng/mL Geometric Coefficient of Variation 13.1	151 ng/mL Geometric Coefficient of Variation 22.8	498 ng/mL Geometric Coefficient of Variation 17.7	1430 ng/mL Geometric Coefficient of Variation 18.0	3820 ng/mL Geometric Coefficient of Variation 25.7	9260 ng/mL Geometric Coefficient of Variation 31.9	12700 ng/mL Geometric Coefficient of Variation 26.3	—	—

SECONDARY outcome

Timeframe: Day 1 and Day 14 (for participants in the 100 mg dose group only) predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours postdose.

Population: The PK parameter population

Outcome measures

Measure	Part 3: 200 mg S-648414 n=8 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=6 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=6 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=8 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted n=6 Participants Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed n=6 Participants Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 n=6 Participants Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 1: Time to Maximum Plasma Concentration (Tmax) of S-648414	1.25 hours Interval 1.0 to 1.5	1.00 hours Interval 1.0 to 1.5	1.00 hours Interval 1.0 to 2.0	3.00 hours Interval 2.0 to 6.0	1.50 hours Interval 1.0 to 2.0	1.50 hours Interval 1.03 to 4.0	1.75 hours Interval 1.5 to 3.0	—	—

SECONDARY outcome

Timeframe: Day 1 and Day 14 (for participants in the 100 mg dose group only) predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours postdose.

Population: The PK parameter population

Area under the concentration-time curve from time zero to the time of the last quantifiable concentration after dosing, calculated by the linear trapezoidal method when concentrations are increasing and by the logarithmic trapezoidal method when concentrations are decreasing (linear up/log down trapezoidal method).

Outcome measures

Measure	Part 3: 200 mg S-648414 n=8 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=6 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=6 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=8 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted n=6 Participants Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed n=6 Participants Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 n=6 Participants Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 1: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration After Dosing (AUC0-last) of S-648414	36370 ng*hr/mL Geometric Coefficient of Variation 9.2	3431 ng*hr/mL Geometric Coefficient of Variation 18.1	10610 ng*hr/mL Geometric Coefficient of Variation 19.3	34910 ng*hr/mL Geometric Coefficient of Variation 14.2	89330 ng*hr/mL Geometric Coefficient of Variation 20.2	215300 ng*hr/mL Geometric Coefficient of Variation 27.1	359300 ng*hr/mL Geometric Coefficient of Variation 23.3	—	—

SECONDARY outcome

Timeframe: Day 1 and Day 14 (for participants in the 100 mg dose group only) predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours postdose.

Population: The PK parameter population

Area under the concentration-time curve extrapolated from time zero to infinity defined as AUC0-last + (Clast/λz), where Clast is the last measurable plasma concentration and λz is the plasma terminal elimination rate constant.

Outcome measures

Measure	Part 3: 200 mg S-648414 n=8 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=6 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=6 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=8 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted n=6 Participants Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed n=6 Participants Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 n=6 Participants Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 1: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of S-648414	38300 ng*hr/mL Geometric Coefficient of Variation 10.9	3620 ng*hr/mL Geometric Coefficient of Variation 17.5	11040 ng*hr/mL Geometric Coefficient of Variation 19.6	36940 ng*hr/mL Geometric Coefficient of Variation 14.4	95510 ng*hr/mL Geometric Coefficient of Variation 21.0	226600 ng*hr/mL Geometric Coefficient of Variation 26.5	382000 ng*hr/mL Geometric Coefficient of Variation 23.6	—	—

SECONDARY outcome

Timeframe: Day 1 and Day 14 (for participants in the 100 mg dose group only) predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours postdose.

Population: The PK parameter population

Terminal elimination half-life calculated as t1/2,z = (ln2)/λz, where λz is the terminal elimination rate constant.

Outcome measures

Measure	Part 3: 200 mg S-648414 n=8 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=6 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=6 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=8 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted n=6 Participants Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed n=6 Participants Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 n=6 Participants Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 1: Terminal Elimination Half-life (t1/2,z) of S-648414	22.2 hours Geometric Coefficient of Variation 16.0	23.0 hours Geometric Coefficient of Variation 5.0	20.7 hours Geometric Coefficient of Variation 9.9	22.8 hours Geometric Coefficient of Variation 14.2	24.1 hours Geometric Coefficient of Variation 12.1	22.2 hours Geometric Coefficient of Variation 12.1	23.7 hours Geometric Coefficient of Variation 14.2	—	—

SECONDARY outcome

Timeframe: Day 1 and Day 14 (for participants in the 100 mg dose group only) predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours postdose.

Population: The PK parameter population

Outcome measures

Measure	Part 3: 200 mg S-648414 n=8 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=6 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=6 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=8 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted n=6 Participants Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed n=6 Participants Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 n=6 Participants Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 1: Terminal Elimination Rate Constant (λz) of S-648414	0.0313 1/hour Geometric Coefficient of Variation 16.0	0.0301 1/hour Geometric Coefficient of Variation 5.0	0.0336 1/hour Geometric Coefficient of Variation 9.9	0.0305 1/hour Geometric Coefficient of Variation 14.2	0.0288 1/hour Geometric Coefficient of Variation 12.1	0.0312 1/hour Geometric Coefficient of Variation 12.1	0.0293 1/hour Geometric Coefficient of Variation 14.2	—	—

SECONDARY outcome

Timeframe: Day 1 and Day 14 (for participants in the 100 mg dose group only) predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours postdose.

Population: The PK parameter population

Mean residence time, calculated as MRT = AUMC0-inf / AUC0-inf, where AUMC0-inf is the area under the first moment curve extrapolated to infinity.

Outcome measures

Measure	Part 3: 200 mg S-648414 n=8 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=6 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=6 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=8 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted n=6 Participants Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed n=6 Participants Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 n=6 Participants Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 1: Mean Residence Time (MRT) of S-648414	31.5 hours Geometric Coefficient of Variation 16.1	32.5 hours Geometric Coefficient of Variation 4.3	29.2 hours Geometric Coefficient of Variation 9.5	33.8 hours Geometric Coefficient of Variation 14.6	34.2 hours Geometric Coefficient of Variation 12.6	32.6 hours Geometric Coefficient of Variation 12.9	34.5 hours Geometric Coefficient of Variation 13.3	—	—

SECONDARY outcome

Timeframe: Day 1 and Day 14 (for participants in the 100 mg dose group only) predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours postdose.

Population: The PK parameter population

Apparent total clearance estimated according to: CL/F = Dose / AUC0-inf.

Outcome measures

Measure	Part 3: 200 mg S-648414 n=8 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=6 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=6 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=8 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted n=6 Participants Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed n=6 Participants Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 n=6 Participants Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 1: Apparent Total Clearance (CL/F) of S-648414	2.61 L/hr Geometric Coefficient of Variation 10.9	2.76 L/hr Geometric Coefficient of Variation 17.5	2.72 L/hr Geometric Coefficient of Variation 19.6	2.71 L/hr Geometric Coefficient of Variation 14.4	2.62 L/hr Geometric Coefficient of Variation 21.0	2.21 L/hr Geometric Coefficient of Variation 26.5	2.62 L/hr Geometric Coefficient of Variation 23.6	—	—

SECONDARY outcome

Timeframe: Day 1 and Day 14 (for participants in the 100 mg dose group only) predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours postdose.

Population: The PK parameter population

Apparent volume of distribution in the terminal elimination phase was estimated according to: Vz /F = Dose / AUC0-inf / λz.

Outcome measures

Measure	Part 3: 200 mg S-648414 n=8 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=6 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=6 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=8 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted n=6 Participants Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed n=6 Participants Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 n=6 Participants Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 1: Apparent Volume of Distribution in the Terminal Elimination Phase (Vz/F) of S-648414	83.5 liters Geometric Coefficient of Variation 11.0	91.7 liters Geometric Coefficient of Variation 21.2	81.0 liters Geometric Coefficient of Variation 21.2	88.9 liters Geometric Coefficient of Variation 19.5	91.0 liters Geometric Coefficient of Variation 17.3	70.8 liters Geometric Coefficient of Variation 31.7	89.3 liters Geometric Coefficient of Variation 23.9	—	—

SECONDARY outcome

Timeframe: Day 1 and Day 14 (for participants in the 100 mg dose group only) predose (-12 to 0 hours), 0 to 24 hours, 24 to 48 hours, 48 to 72 hours, and 72 to 96 hours postdose

Population: The PK parameter population

The fraction of S-648414 dose excreted in urine from 0 to 96 hours postdose was calculated as:

Cumulative amount of S-648414 excreted in urine from time zero to 96 hours postdose (Aeu0-96) / Dose × 100

Outcome measures

Measure	Part 3: 200 mg S-648414 n=8 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=6 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=6 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=8 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted n=6 Participants Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed n=6 Participants Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 n=6 Participants Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 1: Fraction of S-648414 Dose Excreted in Urine From 0 to 96 Hours Postdose (Feu0-96)	25.3 percent excreted Geometric Coefficient of Variation 19.2	30.3 percent excreted Geometric Coefficient of Variation 22.6	25.5 percent excreted Geometric Coefficient of Variation 20.1	25.1 percent excreted Geometric Coefficient of Variation 11.1	28.7 percent excreted Geometric Coefficient of Variation 19.8	31.5 percent excreted Geometric Coefficient of Variation 10.2	25.9 percent excreted Geometric Coefficient of Variation 27.3	—	—

SECONDARY outcome

Timeframe: Day 1 and Day 14 (for participants in the 100 mg dose group only) predose (-12 to 0 hours), 0 to 24 hours, 24 to 48 hours, 48 to 72 hours, and 72 to 96 hours postdose

Population: PK parameter population

Renal clearance was estimated according to: CLR = cumulative amount of S-648414 excreted in urine from time zero to 96 hours postdose (Aeu0-96) / area under the concentration-time curve from time zero to the time of the last quantifiable concentration after dosing (AUC0-last).

Outcome measures

Measure	Part 3: 200 mg S-648414 n=8 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=6 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=6 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=8 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted n=6 Participants Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed n=6 Participants Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 n=6 Participants Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 1: Renal Clearance (CLR) of S-648414	0.695 L/hr Geometric Coefficient of Variation 17.5	0.884 L/hr Geometric Coefficient of Variation 11.6	0.721 L/hr Geometric Coefficient of Variation 25.9	0.720 L/hr Geometric Coefficient of Variation 18.4	0.804 L/hr Geometric Coefficient of Variation 10.3	0.732 L/hr Geometric Coefficient of Variation 30.6	0.720 L/hr Geometric Coefficient of Variation 24.3	—	—

SECONDARY outcome

Timeframe: Day 1 predose (0 hours), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours postdose; Day 14 predose (0 hours), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96 hours postdose.

Population: The PK parameter population with available data at each time point

Outcome measures

Measure	Part 3: 200 mg S-648414 Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=8 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=8 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 2: Maximum Plasma Concentration (Cmax) of S-648414 Following Single and Multiple-dose Administration Day 1	—	411 ng/mL Geometric Coefficient of Variation 22.3	623 ng/mL Geometric Coefficient of Variation 19.2	—	—	—	—	—	—
Part 2: Maximum Plasma Concentration (Cmax) of S-648414 Following Single and Multiple-dose Administration Day 14	—	719 ng/mL Geometric Coefficient of Variation 13.2	1320 ng/mL Geometric Coefficient of Variation 20.2	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 predose (0 hours), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours postdose; Day 14 predose (0 hours), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96 hours postdose.

Population: The PK parameter population with available data at each time point

Outcome measures

Measure	Part 3: 200 mg S-648414 Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=8 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=8 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 2: Time to Maximum Plasma Concentration (Tmax) of S-648414 Following Single and Multiple-dose Administration Day 1	—	3.02 hours Interval 2.0 to 5.0	4.50 hours Interval 2.5 to 5.0	—	—	—	—	—	—
Part 2: Time to Maximum Plasma Concentration (Tmax) of S-648414 Following Single and Multiple-dose Administration Day 14	—	2.03 hours Interval 1.5 to 5.12	1.25 hours Interval 1.0 to 2.5	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 and day 14 predose (0 hours), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours postdose.

Population: The PK parameter population with available data at each time point

Area under the concentration-time curve over the dosing interval (24 hours) on Day 1 and Day 14, calculated by the linear up/log down trapezoidal method.

Outcome measures

Measure	Part 3: 200 mg S-648414 Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=8 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=8 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 2: Area Under the Concentration-time Curve Over the Dosing Interval τ (AUC0-τ) of S-648414 Following Single and Multiple-dose Administration Day 1	—	5519 ng*hr/mL Geometric Coefficient of Variation 15.9	8983 ng*hr/mL Geometric Coefficient of Variation 17.9	—	—	—	—	—	—
Part 2: Area Under the Concentration-time Curve Over the Dosing Interval τ (AUC0-τ) of S-648414 Following Single and Multiple-dose Administration Day 14	—	10540 ng*hr/mL Geometric Coefficient of Variation 14.9	18400 ng*hr/mL Geometric Coefficient of Variation 20.4	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 14 predose (0 hours), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96 hours postdose.

Population: The PK parameter population with available data

Terminal elimination half-life, where t1/2,z = (ln2)/λz on Day 14.

Outcome measures

Measure	Part 3: 200 mg S-648414 Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=8 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=6 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 2: Terminal Elimination Half-life (t1/2,z) of S-648414 Following Multiple-dose Administration	—	21.6 hours Geometric Coefficient of Variation 12.5	23.7 hours Geometric Coefficient of Variation 11.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 14 predose (0 hours), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96 hours postdose.

Population: The PK parameter population with available data

Terminal elimination rate constant, where λz is the magnitude of the slope of the linear regression of the log concentration versus time profile during the terminal phase on Day 14.

Outcome measures

Measure	Part 3: 200 mg S-648414 Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=8 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=6 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 2: Terminal Elimination Rate Constant (λz) of S-648414 Following Multiple-dose Administration	—	0.0321 1/hours Geometric Coefficient of Variation 12.5	0.0292 1/hours Geometric Coefficient of Variation 11.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 14 predose (0 hours), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours postdose.

Population: The PK parameter population with available data

Apparent total clearance estimated according to: CL/F = Dose/AUC0-τ on Day 14

Outcome measures

Measure	Part 3: 200 mg S-648414 Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=8 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=6 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 2: Apparent Total Clearance (CL/F) of S-648414 Following Multiple-dose Administration	—	2.85 L/hr Geometric Coefficient of Variation 14.9	2.72 L/hr Geometric Coefficient of Variation 20.4	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 14 predose (0 hours), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96 hours postdose.

Population: The PK parameter population with available data

Apparent volume of distribution in the terminal elimination phase on Day 14, estimated according to: Vz /F = Dose/AUC0-τ/λz

Outcome measures

Measure	Part 3: 200 mg S-648414 Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=8 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=6 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 2: Apparent Volume of Distribution in the Terminal Elimination Phase (Vz/F) of S-648414 Following Multiple-dose Administration	—	88.7 liters Geometric Coefficient of Variation 13.6	93.0 liters Geometric Coefficient of Variation 28.5	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 14 0-24 hours postdose

Population: The PK parameter population with available data

Fraction of dose excreted in urine over the dosing interval τ (24 hours) on Day 14 calculated as Aeu0-τ/Dose × 100, where Aeu0-τ is the amount of drug excreted in urine over the dosing interval τ (24 hours).

Outcome measures

Measure	Part 3: 200 mg S-648414 Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=8 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=6 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 2: Fraction of S-648414 Dose Excreted in Urine Over the Dosing Interval (Feu0- τ) Following Multiple-dose Administration	—	33.3 percent excreted Geometric Coefficient of Variation 15.7	35.0 percent excreted Geometric Coefficient of Variation 25.6	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 14 0-24 hours postdose

Population: The PK parameter population with available data

Renal clearance on Day 14, calculated as CLR = Aeu0-τ/AUC0-τ, where Aeu0-τ is the amount of drug excreted in urine over the dosing interval τ (24 hours)

Outcome measures

Measure	Part 3: 200 mg S-648414 Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=8 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=6 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 2: Renal Clearance (CLR) of S-648414 Following Multiple-dose Administration	—	0.948 L/hr Geometric Coefficient of Variation 18.4	0.952 L/hr Geometric Coefficient of Variation 18.1	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day -2 and Day 14 predose (0 hours), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours postdose.

Population: The PK parameter population with available data

The effect of S-648414 on the PK of midazolam (a cytochrome P450 3A [CYP3A] substrate) was assessed in Part 2 following 5 mg midazolam administration alone (Day -2) and co-administration with S-648414 30 or 50 mg (Day 14).

Outcome measures

Measure	Part 3: 200 mg S-648414 n=8 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=8 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=8 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=6 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 2: Maximum Plasma Concentration (Cmax) of Midazolam	19.5 ng/mL Geometric Coefficient of Variation 30.6	18.0 ng/mL Geometric Coefficient of Variation 33.6	16.8 ng/mL Geometric Coefficient of Variation 25.6	19.3 ng/mL Geometric Coefficient of Variation 33.2	—	—	—	—	—

SECONDARY outcome

Timeframe: Day -2 and Day 14 predose (0 hours), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours postdose.

Population: The PK parameter population with available data

The effect of S-648414 on the PK of midazolam (a cytochrome P450 3A [CYP3A] substrate) was assessed in Part 2 following 5 mg midazolam administration alone (Day -2) and co-administration with S-648414 30 or 50 mg (Day 14).

Outcome measures

Measure	Part 3: 200 mg S-648414 n=8 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=8 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=8 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=6 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 2: Time to Maximum Plasma Concentration of Midazolam	0.50 hours Interval 0.5 to 1.0	0.76 hours Interval 0.5 to 2.0	1.00 hours Interval 0.5 to 2.08	0.50 hours Interval 0.5 to 1.0	—	—	—	—	—

SECONDARY outcome

Timeframe: Day -2 and Day 14 predose (0 hours), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours postdose.

Population: The PK parameter population with available data

The effect of S-648414 on the PK of midazolam (a cytochrome P450 3A [CYP3A] substrate) was assessed in Part 2 following 5 mg midazolam administration alone (Day -2) and co-administration with S-648414 30 or 50 mg (Day 14).

Area under the concentration-time curve from time zero to the time of the last quantifiable concentration after dosing, calculated by linear up/log down trapezoidal method.

Outcome measures

Measure	Part 3: 200 mg S-648414 n=8 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=8 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=8 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=6 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 2: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration After Dosing (AUC0-last) for Midazolam	73.28 ng*hr/mL Geometric Coefficient of Variation 40.7	70.17 ng*hr/mL Geometric Coefficient of Variation 30.7	59.83 ng*hr/mL Geometric Coefficient of Variation 40.5	64.53 ng*hr/mL Geometric Coefficient of Variation 35.6	—	—	—	—	—

SECONDARY outcome

Timeframe: Day -2 and Day 14 predose (0 hours), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours postdose.

Population: The PK parameter population with available data

The effect of S-648414 on the PK of midazolam (a cytochrome P450 3A [CYP3A] substrate) was assessed in Part 2 following 5 mg midazolam administration alone (Day -2) and co-administration with S-648414 30 or 50 mg (Day 14).

Area under the concentration-time curve extrapolated from time zero to infinity defined as AUC0-last + (Clast/λz), where Clast is the last measurable plasma concentration and λz is the plasma terminal elimination rate constant.

Outcome measures

Measure	Part 3: 200 mg S-648414 n=8 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=8 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=8 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=6 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 2: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Midazolam	76.03 ng*hr/mL Geometric Coefficient of Variation 42.2	72.81 ng*hr/mL Geometric Coefficient of Variation 28.7	61.68 ng*hr/mL Geometric Coefficient of Variation 41.2	67.02 ng*hr/mL Geometric Coefficient of Variation 37.1	—	—	—	—	—

SECONDARY outcome

Timeframe: Day -2 and Day 14 predose (0 hours), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours postdose.

Population: The PK parameter population with available data

The effect of S-648414 on the PK of midazolam (a cytochrome P450 3A [CYP3A] substrate) was assessed in Part 2 following 5 mg midazolam administration alone (Day -2) and co-administration with S-648414 30 or 50 mg (Day 14).

Outcome measures

Measure	Part 3: 200 mg S-648414 n=8 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=8 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=8 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=6 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 2: Terminal Elimination Half-life for Midazolam	4.41 hours Geometric Coefficient of Variation 41.1	5.07 hours Geometric Coefficient of Variation 18.7	4.64 hours Geometric Coefficient of Variation 32.4	4.54 hours Geometric Coefficient of Variation 39.5	—	—	—	—	—

SECONDARY outcome

Timeframe: Day -2 and Day 14 predose (0 hours), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours postdose.

Population: The PK parameter population with available data

The effect of S-648414 on the PK of midazolam (a cytochrome P450 3A [CYP3A] substrate) was assessed in Part 2 following 5 mg midazolam administration alone (Day -2) and co-administration with S-648414 30 or 50 mg (Day 14).

Outcome measures

Measure	Part 3: 200 mg S-648414 n=8 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=8 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=8 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=6 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 2: Terminal Elimination Rate Constant for Midazolam	0.1570 1/hour Geometric Coefficient of Variation 41.1	0.1366 1/hour Geometric Coefficient of Variation 18.7	0.1494 1/hour Geometric Coefficient of Variation 32.4	0.1528 1/hour Geometric Coefficient of Variation 39.5	—	—	—	—	—

SECONDARY outcome

Timeframe: Day -2 and Day 14 predose (0 hours), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours postdose.

Population: The PK parameter population with available data

The effect of S-648414 on the PK of midazolam (a cytochrome P450 3A [CYP3A] substrate) was assessed in Part 2 following 5 mg midazolam administration alone (Day -2) and co-administration with S-648414 30 or 50 mg (Day 14).

Mean residence time was calculated as MRT = AUMC0-inf/AUC0-inf where AUMC0-inf is the area under the first moment curve extrapolated to infinity.

Outcome measures

Measure	Part 3: 200 mg S-648414 n=8 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=8 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=8 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=6 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 2: Mean Residence Time for Midazolam	4.93 hours Geometric Coefficient of Variation 33.8	5.30 hours Geometric Coefficient of Variation 8.6	4.44 hours Geometric Coefficient of Variation 28.3	4.40 hours Geometric Coefficient of Variation 38.0	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1: Predose at 3 time points (-45, -30 and -15 minutes), and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose.

Population: The QT/QTc population included all study participants randomly assigned to study intervention and who took at least 1 dose of study intervention.who had measurements at Baseline as well as on-treatment, with at least 1 post-dose time point with a valid ΔQTcF value. Participants with available data at each time point are included. Cardiodynamic ECG assessments were performed for Part 1 only.

Continuous 12-lead digital electrocardiogram (ECG) recording was performed on Day 1. The QT interval is a measure between Q and T wave in heart's electrical cycle. ECGs were analyzed at a blinded, central ECG laboratory. At each specified time point, ten 14-second 12-lead ECG tracings were extracted from the continuous recordings. The median QT in each replicate was calculated; the mean of available medians was used as the participant's reportable value at that time point.

QT interval was corrected for heart rate using Fridericia's correction (QTcF). Baseline was defined as the average of the measured ECG intervals from the 3 pre-dose time points (45, 30, and 15 minutes before dosing) on Day 1.

Change from Baseline (ΔQTcF) was calculated based on a linear mixed-effects model with time (categorical), treatment, and time-by-treatment interaction as fixed effects and Baseline QTcF as covariate.

Outcome measures

Measure	Part 3: 200 mg S-648414 n=6 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=12 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=6 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=8 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted n=6 Participants Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed n=6 Participants Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 n=6 Participants Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 1: Change From Baseline in Fridericia's Corrected QT Interval (QTcF) 0.5 hours postdose	-5.6 ms Standard Error 1.61	-3.2 ms Standard Error 1.16	-3.2 ms Standard Error 1.61	-4.8 ms Standard Error 1.40	-4.1 ms Standard Error 1.64	-5.6 ms Standard Error 1.69	2.0 ms Standard Error 1.62	—	—
Part 1: Change From Baseline in Fridericia's Corrected QT Interval (QTcF) 1 hour postdose	-2.4 ms Standard Error 1.66	-2.2 ms Standard Error 1.19	-0.4 ms Standard Error 1.66	-3.2 ms Standard Error 1.44	-0.9 ms Standard Error 1.69	-1.0 ms Standard Error 1.74	4.9 ms Standard Error 1.67	—	—
Part 1: Change From Baseline in Fridericia's Corrected QT Interval (QTcF) 1.5 hours postdose	-2.6 ms Standard Error 1.96	-1.1 ms Standard Error 1.40	-1.2 ms Standard Error 1.96	-1.1 ms Standard Error 1.69	1.8 ms Standard Error 1.98	3.1 ms Standard Error 2.02	4.9 ms Standard Error 1.96	—	—
Part 1: Change From Baseline in Fridericia's Corrected QT Interval (QTcF) 2 hours postdose	-1.0 ms Standard Error 1.93	-0.1 ms Standard Error 1.38	-2.1 ms Standard Error 1.93	-1.9 ms Standard Error 1.67	-1.2 ms Standard Error 1.95	2.4 ms Standard Error 1.99	6.3 ms Standard Error 1.93	—	—
Part 1: Change From Baseline in Fridericia's Corrected QT Interval (QTcF) 2.5 hours postdose	-1.5 ms Standard Error 1.94	-2.5 ms Standard Error 1.39	-1.7 ms Standard Error 1.94	-1.1 ms Standard Error 1.68	0.4 ms Standard Error 1.97	2.5 ms Standard Error 2.01	8.0 ms Standard Error 1.95	—	—
Part 1: Change From Baseline in Fridericia's Corrected QT Interval (QTcF) 3 hours postdose	-1.3 ms Standard Error 1.73	-1.9 ms Standard Error 1.24	2.3 ms Standard Error 1.73	-0.6 ms Standard Error 1.50	2.6 ms Standard Error 1.76	-0.4 ms Standard Error 1.80	10.1 ms Standard Error 1.74	—	—
Part 1: Change From Baseline in Fridericia's Corrected QT Interval (QTcF) 4 hours postdose	-0.6 ms Standard Error 2.16	-2.3 ms Standard Error 1.54	-0.2 ms Standard Error 2.16	0.1 ms Standard Error 1.87	0.2 ms Standard Error 2.18	3.6 ms Standard Error 2.22	12.0 ms Standard Error 2.17	—	—
Part 1: Change From Baseline in Fridericia's Corrected QT Interval (QTcF) 6 hours postdose	-2.3 ms Standard Error 3.56	-5.3 ms Standard Error 2.52	-12.0 ms Standard Error 3.55	-1.2 ms Standard Error 3.08	-4.6 ms Standard Error 3.57	-4.6 ms Standard Error 3.59	2.9 ms Standard Error 3.56	—	—
Part 1: Change From Baseline in Fridericia's Corrected QT Interval (QTcF) 8 hours postdose	-0.3 ms Standard Error 2.41	-4.1 ms Standard Error 1.71	-6.7 ms Standard Error 2.41	-3.2 ms Standard Error 2.08	-5.9 ms Standard Error 2.43	-3.4 ms Standard Error 2.46	5.0 ms Standard Error 2.41	—	—
Part 1: Change From Baseline in Fridericia's Corrected QT Interval (QTcF) 12 hours postdose	0.9 ms Standard Error 3.44	-0.9 ms Standard Error 2.44	-1.8 ms Standard Error 3.44	1.0 ms Standard Error 2.98	-1.3 ms Standard Error 3.45	-3.0 ms Standard Error 3.48	8.8 ms Standard Error 3.44	—	—
Part 1: Change From Baseline in Fridericia's Corrected QT Interval (QTcF) 24 hours postdose	-1.2 ms Standard Error 1.66	-1.4 ms Standard Error 1.19	-4.9 ms Standard Error 1.66	-2.1 ms Standard Error 1.44	-0.8 ms Standard Error 1.69	-1.8 ms Standard Error 1.74	7.5 ms Standard Error 2.01	—	—

SECONDARY outcome

Timeframe: Day 1: Predose at 3 time points (-45, -30 and -15 minutes), and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose.

Population: The QT/QTc population with available data at each time point

Continuous 12-lead digital electrocardiogram (ECG) recording was performed on Day 1. ECGs were analyzed at a blinded, central ECG laboratory. At each specified time point, ten 14-second 12-lead ECG tracings were extracted from the continuous recordings. The median HR in each replicate was calculated; the mean of available medians was used as the participant's reportable value at that time point.

Baseline was defined as the average of the measured ECG values from the 3 pre-dose time points (45, 30, and 15 minutes before dosing) on Day 1.

Change from Baseline in HR (ΔHR) was calculated based on a linear mixed-effects model with time (categorical), treatment, and time-by-treatment interaction as fixed effects and Baseline HR as covariate.

Outcome measures

Measure	Part 3: 200 mg S-648414 n=6 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=12 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=6 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=8 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted n=6 Participants Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed n=6 Participants Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 n=6 Participants Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Parts 1: Change From Baseline in Heart Rate (HR) 2.5 hours postdose	-3.0 beats per minute Standard Error 1.84	0.8 beats per minute Standard Error 1.28	-1.2 beats per minute Standard Error 1.82	-2.2 beats per minute Standard Error 1.57	-0.7 beats per minute Standard Error 1.81	2.7 beats per minute Standard Error 1.81	-0.7 beats per minute Standard Error 1.81	—	—
Parts 1: Change From Baseline in Heart Rate (HR) 3 hours postdose	-1.6 beats per minute Standard Error 1.97	-0.9 beats per minute Standard Error 1.38	-3.0 beats per minute Standard Error 1.96	-2.1 beats per minute Standard Error 1.69	-1.8 beats per minute Standard Error 1.95	2.0 beats per minute Standard Error 1.95	-0.6 beats per minute Standard Error 1.95	—	—
Parts 1: Change From Baseline in Heart Rate (HR) 4 hours postdose	0.7 beats per minute Standard Error 2.02	0.2 beats per minute Standard Error 1.41	-1.2 beats per minute Standard Error 2.00	-2.8 beats per minute Standard Error 1.73	0.8 beats per minute Standard Error 2.00	2.1 beats per minute Standard Error 2.00	3.3 beats per minute Standard Error 2.00	—	—
Parts 1: Change From Baseline in Heart Rate (HR) 6 hours postdose	2.4 beats per minute Standard Error 1.70	5.2 beats per minute Standard Error 1.18	4.6 beats per minute Standard Error 1.68	4.2 beats per minute Standard Error 1.45	3.7 beats per minute Standard Error 1.67	7.3 beats per minute Standard Error 1.67	7.5 beats per minute Standard Error 1.67	—	—
Parts 1: Change From Baseline in Heart Rate (HR) 8 hours postdose	0.7 beats per minute Standard Error 2.22	1.5 beats per minute Standard Error 1.56	1.7 beats per minute Standard Error 2.21	-0.2 beats per minute Standard Error 1.91	1.8 beats per minute Standard Error 2.20	4.6 beats per minute Standard Error 2.20	3.5 beats per minute Standard Error 2.20	—	—
Parts 1: Change From Baseline in Heart Rate (HR) 24 hours postdose	-0.4 beats per minute Standard Error 2.34	0.4 beats per minute Standard Error 1.64	-1.7 beats per minute Standard Error 2.33	-1.4 beats per minute Standard Error 2.01	0.8 beats per minute Standard Error 2.33	0.3 beats per minute Standard Error 2.32	3.3 beats per minute Standard Error 2.59	—	—
Parts 1: Change From Baseline in Heart Rate (HR) 12 hours postdose	1.9 beats per minute Standard Error 2.56	2.7 beats per minute Standard Error 1.80	1.1 beats per minute Standard Error 2.55	1.1 beats per minute Standard Error 2.21	2.4 beats per minute Standard Error 2.55	9.1 beats per minute Standard Error 2.55	3.4 beats per minute Standard Error 2.55	—	—
Parts 1: Change From Baseline in Heart Rate (HR) 0.5 hours postdose	-1.4 beats per minute Standard Error 1.60	0.9 beats per minute Standard Error 1.11	-0.2 beats per minute Standard Error 1.58	-1.1 beats per minute Standard Error 1.36	-0.1 beats per minute Standard Error 1.57	-0.7 beats per minute Standard Error 1.57	-1.6 beats per minute Standard Error 1.57	—	—
Parts 1: Change From Baseline in Heart Rate (HR) 1 hour postdose	-1.9 beats per minute Standard Error 1.66	1.5 beats per minute Standard Error 1.16	-2.7 beats per minute Standard Error 1.64	-2.1 beats per minute Standard Error 1.41	0.4 beats per minute Standard Error 1.64	-1.0 beats per minute Standard Error 1.63	-0.8 beats per minute Standard Error 1.63	—	—
Parts 1: Change From Baseline in Heart Rate (HR) 1.5 hours postdose	-0.3 beats per minute Standard Error 1.69	-0.4 beats per minute Standard Error 1.18	-3.0 beats per minute Standard Error 1.67	-3.0 beats per minute Standard Error 1.44	-0.5 beats per minute Standard Error 1.67	0.2 beats per minute Standard Error 1.67	-0.4 beats per minute Standard Error 1.66	—	—
Parts 1: Change From Baseline in Heart Rate (HR) 2 hours postdose	-2.4 beats per minute Standard Error 1.87	-0.5 beats per minute Standard Error 1.30	-3.2 beats per minute Standard Error 1.85	-2.5 beats per minute Standard Error 1.60	-1.7 beats per minute Standard Error 1.85	0.4 beats per minute Standard Error 1.85	-0.3 beats per minute Standard Error 1.84	—	—

SECONDARY outcome

Timeframe: Day 1: Predose at 3 time points (-45, -30 and -15 minutes), and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose.

Population: The QT/QTc population with available data at each time point

Continuous 12-lead digital electrocardiogram (ECG) recording was performed on Day 1. The PR interval is the time from the onset of the P-wave to the start of the next QRS complex. ECGs were analyzed at a blinded, central ECG laboratory. At each specified time point, ten 14-second 12-lead ECG tracings were extracted from the continuous recordings. The median PR in each replicate was calculated; the mean of available medians was used as the participant's reportable value at that time point.

Baseline was defined as the average of the measured ECG intervals from the 3 pre-dose time points (45, 30, and 15 minutes before dosing) on Day 1.

Change from Baseline in PR interval (ΔPR) was calculated based on a linear mixed-effects model with time (categorical), treatment, and time-by-treatment interaction as fixed effects and Baseline PR as covariate.

Outcome measures

Measure	Part 3: 200 mg S-648414 n=6 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=12 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=6 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=8 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted n=6 Participants Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed n=6 Participants Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 n=6 Participants Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 1: Change From Baseline in PR Interval 0.5 hours postdose	2.2 ms Standard Error 1.83	0.4 ms Standard Error 1.29	1.0 ms Standard Error 1.87	-0.1 ms Standard Error 1.61	1.3 ms Standard Error 1.85	-3.9 ms Standard Error 1.84	0.0 ms Standard Error 1.83	—	—
Part 1: Change From Baseline in PR Interval 1 hour postdose	4.0 ms Standard Error 1.82	0.9 ms Standard Error 1.29	1.0 ms Standard Error 1.86	1.3 ms Standard Error 1.60	1.9 ms Standard Error 1.84	-6.4 ms Standard Error 1.83	1.0 ms Standard Error 1.82	—	—
Part 1: Change From Baseline in PR Interval 1.5 hours postdose	1.0 ms Standard Error 2.46	0.4 ms Standard Error 1.74	3.4 ms Standard Error 2.49	0.9 ms Standard Error 2.15	2.2 ms Standard Error 2.47	0.8 ms Standard Error 2.47	0.9 ms Standard Error 2.46	—	—
Part 1: Change From Baseline in PR Interval 2 hours postdose	3.4 ms Standard Error 2.03	0.8 ms Standard Error 1.44	2.8 ms Standard Error 2.07	-2.3 ms Standard Error 1.78	-1.4 ms Standard Error 2.05	-2.1 ms Standard Error 2.04	0.2 ms Standard Error 2.04	—	—
Part 1: Change From Baseline in PR Interval 2.5 hours postdose	4.5 ms Standard Error 2.26	0.7 ms Standard Error 1.60	1.1 ms Standard Error 2.29	-0.1 ms Standard Error 1.97	0.5 ms Standard Error 2.27	-5.2 ms Standard Error 2.26	-0.9 ms Standard Error 2.26	—	—
Part 1: Change From Baseline in PR Interval 3 hours postdose	3.7 ms Standard Error 2.64	-0.1 ms Standard Error 1.86	3.6 ms Standard Error 2.67	1.7 ms Standard Error 2.30	-1.5 ms Standard Error 2.65	-5.3 ms Standard Error 2.64	-0.7 ms Standard Error 2.64	—	—
Part 1: Change From Baseline in PR Interval 4 hours postdose	3.1 ms Standard Error 2.36	0.5 ms Standard Error 1.67	3.0 ms Standard Error 2.39	-1.0 ms Standard Error 2.06	-0.1 ms Standard Error 2.37	-6.9 ms Standard Error 2.36	-1.7 ms Standard Error 2.36	—	—
Part 1: Change From Baseline in PR Interval 6 hours postdose	0.7 ms Standard Error 2.21	-2.8 ms Standard Error 1.56	-1.6 ms Standard Error 2.24	-2.3 ms Standard Error 1.93	-0.9 ms Standard Error 2.22	-7.0 ms Standard Error 2.21	-3.0 ms Standard Error 2.21	—	—
Part 1: Change From Baseline in PR Interval 8 hours postdose	3.6 ms Standard Error 2.68	-3.2 ms Standard Error 1.90	-1.8 ms Standard Error 2.71	-4.5 ms Standard Error 2.34	-5.8 ms Standard Error 2.69	-5.8 ms Standard Error 2.69	-1.8 ms Standard Error 2.68	—	—
Part 1: Change From Baseline in PR Interval 12 hours postdose	3.5 ms Standard Error 3.00	-0.9 ms Standard Error 2.12	0.4 ms Standard Error 3.03	-1.3 ms Standard Error 2.61	-1.0 ms Standard Error 3.01	-7.8 ms Standard Error 3.01	-0.5 ms Standard Error 3.01	—	—
Part 1: Change From Baseline in PR Interval 24 hours postdose	0.8 ms Standard Error 2.28	-1.5 ms Standard Error 1.61	0.1 ms Standard Error 2.32	0.5 ms Standard Error 1.99	-4.2 ms Standard Error 2.29	-2.2 ms Standard Error 2.29	-3.1 ms Standard Error 2.52	—	—

SECONDARY outcome

Timeframe: Day 1: Predose at 3 time points (-45, -30 and -15 minutes), and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose.

Population: The QT/QTc population with available data at each time point

Continuous 12-lead digital electrocardiogram (ECG) recording was performed on Day 1. The QRS complex is a combination of the Q wave, R wave and S wave on an ECG tracing, and represents ventricular depolarization. ECGs were analyzed at a blinded, central ECG laboratory. At each specified time point, ten 14-second 12-lead ECG tracings were extracted from the continuous recordings. The median QRS in each replicate was calculated; the mean of available medians was used as the participant's reportable value at that time point.

Baseline was defined as the average of the measured ECG intervals from the 3 pre-dose time points (45, 30, and 15 minutes before dosing) on Day 1.

Change from Baseline in QRS interval (ΔQRS) was calculated based on a linear mixed-effects model with time (categorical), treatment, and time-by-treatment interaction as fixed effects and Baseline QRS as covariate.

Outcome measures

Measure	Part 3: 200 mg S-648414 n=6 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=12 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=6 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=8 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted n=6 Participants Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed n=6 Participants Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 n=6 Participants Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 1: Change From Baseline in QRS Interval 1 hour postdose	0.1 ms Standard Error 0.32	-0.4 ms Standard Error 0.22	-0.1 ms Standard Error 0.32	0.2 ms Standard Error 0.27	0.3 ms Standard Error 0.32	0.2 ms Standard Error 0.32	0.4 ms Standard Error 0.32	—	—
Part 1: Change From Baseline in QRS Interval 1.5 hours postdose	0.0 ms Standard Error 0.63	0.5 ms Standard Error 0.45	-0.2 ms Standard Error 0.63	0.4 ms Standard Error 0.55	0.5 ms Standard Error 0.63	0.3 ms Standard Error 0.63	0.6 ms Standard Error 0.63	—	—
Part 1: Change From Baseline in QRS Interval 0.5 hours postdose	-0.4 ms Standard Error 0.30	-0.3 ms Standard Error 0.21	0.0 ms Standard Error 0.31	0.2 ms Standard Error 0.26	-0.1 ms Standard Error 0.31	0.1 ms Standard Error 0.30	-.1 ms Standard Error 0.31	—	—
Part 1: Change From Baseline in QRS Interval 2 hours postdose	0.1 ms Standard Error 0.34	-0.3 ms Standard Error 0.24	0.2 ms Standard Error 0.34	0.7 ms Standard Error 0.29	0.1 ms Standard Error 0.34	0.4 ms Standard Error 0.34	0.8 ms Standard Error 0.34	—	—
Part 1: Change From Baseline in QRS Interval 2.5 hours postdose	0.2 ms Standard Error 0.34	-0.1 ms Standard Error 0.24	0.0 ms Standard Error 0.34	-0.2 ms Standard Error 0.30	0.2 ms Standard Error 0.34	0.0 ms Standard Error 0.34	0.3 ms Standard Error 0.34	—	—
Part 1: Change From Baseline in QRS Interval 3 hours postdose	0.2 ms Standard Error 0.31	-0.2 ms Standard Error 0.22	0.0 ms Standard Error 0.31	0.1 ms Standard Error 0.27	0.4 ms Standard Error 0.31	0.4 ms Standard Error 0.31	0.2 ms Standard Error 0.31	—	—
Part 1: Change From Baseline in QRS Interval 4 hours postdose	0.2 ms Standard Error 0.41	0.2 ms Standard Error 0.29	-0.1 ms Standard Error 0.41	0.5 ms Standard Error 0.35	0.3 ms Standard Error 0.41	0.9 ms Standard Error 0.41	1.0 ms Standard Error 0.41	—	—
Part 1: Change From Baseline in QRS Interval 6 hours postdose	-0.5 ms Standard Error 0.77	-0.5 ms Standard Error 0.55	-0.8 ms Standard Error 0.78	-0.7 ms Standard Error 0.67	-1.3 ms Standard Error 0.78	0.6 ms Standard Error 0.77	0.8 ms Standard Error 0.78	—	—
Part 1: Change From Baseline in QRS Interval 8 hours postdose	-0.2 ms Standard Error 0.47	-0.8 ms Standard Error 0.33	-0.6 ms Standard Error 0.47	-0.3 ms Standard Error 0.41	-0.3 ms Standard Error 0.47	0.2 ms Standard Error 0.47	-0.5 ms Standard Error 0.47	—	—
Part 1: Change From Baseline in QRS Interval 12 hours postdose	0.0 ms Standard Error 0.54	-1.4 ms Standard Error 0.38	0.0 ms Standard Error 0.54	-0.3 ms Standard Error 0.47	-0.3 ms Standard Error 0.54	0.5 ms Standard Error 0.54	0.5 ms Standard Error 0.54	—	—
Part 1: Change From Baseline in QRS Interval 24 hours postdose	0.1 ms Standard Error 0.55	-0.7 ms Standard Error 0.39	0.1 ms Standard Error 0.55	0.4 ms Standard Error 0.48	-0.1 ms Standard Error 0.55	0.0 ms Standard Error 0.55	-0.7 ms Standard Error 0.64	—	—

SECONDARY outcome

Timeframe: Day 1: Predose at 3 time points (-45, -30 and -15 minutes), and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose.

Population: The QT/QTc population with available data at each time point. The number of participants analyzed includes participants in each S-648414 group with available data; reported values are corrected for placebo data collected for the 12 participants in the Part 1 Placebo group.

Continuous 12-lead digital electrocardiogram (ECG) recording was performed on Day 1. ECGs were analyzed at a blinded, central ECG laboratory. At each specified time point, ten 14-second 12-lead ECG tracings were extracted from the continuous recordings. The median QT in each replicate was calculated; the mean of available medians was used as the participant's reportable value at that time point.

QT interval was corrected for heart rate using Fridericia's correction (QTcF). Baseline was defined as the average of the measured ECG intervals from the 3 pre-dose time points (45, 30, and 15 minutes before dosing) on Day 1.

Change from Baseline (ΔQTcF) was calculated based on a linear mixed-effects model with time (categorical), treatment, and time-by-treatment interaction as fixed effects and Baseline QTcF as covariate.

Placebo-corrected ΔQTcF (ΔΔQTcF) was calculated as the adjusted mean ΔQTcF in the S-648414 group minus adjusted mean ΔQTcF in the placebo group at each time point.

Outcome measures

Measure	Part 3: 200 mg S-648414 n=8 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=8 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=8 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=6 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted n=6 Participants Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed n=6 Participants Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 1: Placebo-corrected Change From Baseline in Fridericia's Corrected QT Interval 0.5 hours postdose	-1.6 ms Standard Error 1.81	0.0 ms Standard Error 1.98	-2.4 ms Standard Error 1.99	-0.9 ms Standard Error 1.98	-2.4 ms Standard Error 2.10	5.2 ms Standard Error 2.00	—	—	—
Part 1: Placebo-corrected Change From Baseline in Fridericia's Corrected QT Interval 1 hour postdose	-1.0 ms Standard Error 1.87	1.7 ms Standard Error 2.04	-0.2 ms Standard Error 2.06	1.2 ms Standard Error 2.04	1.1 ms Standard Error 2.16	7.0 ms Standard Error 2.07	—	—	—
Part 1: Placebo-corrected Change From Baseline in Fridericia's Corrected QT Interval 1.5 hours postdose	0.0 ms Standard Error 2.20	-0.1 ms Standard Error 2.40	-1.5 ms Standard Error 2.41	3.0 ms Standard Error 2.40	4.2 ms Standard Error 2.50	6.0 ms Standard Error 2.42	—	—	—
Part 1: Placebo-corrected Change From Baseline in Fridericia's Corrected QT Interval 2 hours postdose	-1.8 ms Standard Error 2.16	-2.0 ms Standard Error 2.37	-0.9 ms Standard Error 2.38	-1.1 ms Standard Error 2.36	2.5 ms Standard Error 2.46	6.4 ms Standard Error 2.39	—	—	—
Part 1: Placebo-corrected Change From Baseline in Fridericia's Corrected QT Interval 2.5 hours postdose	1.4 ms Standard Error 2.18	0.8 ms Standard Error 2.38	1.0 ms Standard Error 2.39	2.8 ms Standard Error 2.38	5.0 ms Standard Error 2.48	10.4 ms Standard Error 2.40	—	—	—
Part 1: Placebo-corrected Change From Baseline in Fridericia's Corrected QT Interval 3 hours postdose	1.2 ms Standard Error 1.94	4.1 ms Standard Error 2.13	0.5 ms Standard Error 2.14	4.5 ms Standard Error 2.12	1.4 ms Standard Error 2.24	12.0 ms Standard Error 2.15	—	—	—
Part 1: Placebo-corrected Change From Baseline in Fridericia's Corrected QT Interval 4 hours postdose	2.4 ms Standard Error 2.42	2.1 ms Standard Error 2.65	1.7 ms Standard Error 2.66	2.5 ms Standard Error 2.65	5.9 ms Standard Error 2.74	14.3 ms Standard Error 2.67	—	—	—
Part 1: Placebo-corrected Change From Baseline in Fridericia's Corrected QT Interval 6 hours postdose	4.0 ms Standard Error 3.98	-6.7 ms Standard Error 4.36	3.0 ms Standard Error 4.36	0.7 ms Standard Error 4.36	0.6 ms Standard Error 4.41	8.1 ms Standard Error 4.37	—	—	—
Part 1: Placebo-corrected Change From Baseline in Fridericia's Corrected QT Interval 8 hours postdose	0.9 ms Standard Error 2.70	-2.7 ms Standard Error 2.95	3.7 ms Standard Error 2.96	-1.8 ms Standard Error 2.95	0.7 ms Standard Error 3.03	9.1 ms Standard Error 2.97	—	—	—
Part 1: Placebo-corrected Change From Baseline in Fridericia's Corrected QT Interval 12 hours postdose	1.8 ms Standard Error 3.85	-1.0 ms Standard Error 4.21	1.8 ms Standard Error 4.22	-0.5 ms Standard Error 4.21	-2.1 ms Standard Error 4.27	9.6 ms Standard Error 4.23	—	—	—
Part 1: Placebo-corrected Change From Baseline in Fridericia's Corrected QT Interval 24 hours postdose	-0.7 ms Standard Error 1.86	-3.6 ms Standard Error 2.04	0.2 ms Standard Error 2.05	0.5 ms Standard Error 2.03	-0.4 ms Standard Error 2.15	8.8 ms Standard Error 2.36	—	—	—

SECONDARY outcome

Timeframe: Day 1: Predose at 3 time points (-45, -30 and -15 minutes), and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose.

Population: The QT/QTc population with available data at each time point. The number of participants analyzed includes participants in each S-648414 group with available data; reported values are corrected for placebo data collected for the 12 participants in the Part 1 Placebo group.

Continuous 12-lead digital electrocardiogram (ECG) recording was performed on Day 1. ECGs were analyzed at a blinded, central ECG laboratory. At each specified time point, ten 14-second 12-lead ECG tracings were extracted from the continuous recordings. The median HR in each replicate was calculated; the mean of available medians was used as the participant's reportable value at that time point.

Baseline was defined as the average of the measured values from the 3 pre-dose time points (45, 30, and 15 minutes before dosing) on Day 1.

Change from Baseline (ΔHR) was calculated based on a linear mixed-effects model with time (categorical), treatment, and time-by-treatment interaction as fixed effects and Baseline HR as covariate.

Placebo-corrected ΔHR (ΔΔHR) was calculated as the adjusted mean ΔHR in the S-648414 group minus adjusted mean ΔHR in the placebo group at each time point.

Outcome measures

Measure	Part 3: 200 mg S-648414 n=8 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=6 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=6 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=6 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted n=6 Participants Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed n=6 Participants Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 1: Placebo-corrected Change From Baseline in Heart Rate 6 hours postdose	-1.0 beats per minute Standard Error 1.87	-0.6 beats per minute Standard Error 2.05	-2.8 beats per minute Standard Error 2.07	-1.5 beats per minute Standard Error 2.05	2.0 beats per minute Standard Error 2.05	2.3 beats per minute Standard Error 2.05	—	—	—
Part 1: Placebo-corrected Change From Baseline in Heart Rate 0.5 hours postdose	-2.0 beats per minute Standard Error 1.76	-1.1 beats per minute Standard Error 1.93	-2.3 beats per minute Standard Error 1.95	-1.0 beats per minute Standard Error 1.92	-1.6 beats per minute Standard Error 1.93	-2.5 beats per minute Standard Error 1.92	—	—	—
Part 1: Placebo-corrected Change From Baseline in Heart Rate 1 hour postdose	-3.5 beats per minute Standard Error 1.83	-4.2 beats per minute Standard Error 2.00	-3.4 beats per minute Standard Error 2.03	-1.1 beats per minute Standard Error 2.00	-2.5 beats per minute Standard Error 2.00	-2.2 beats per minute Standard Error 2.00	—	—	—
Part 1: Placebo-corrected Change From Baseline in Heart Rate 1.5 hours postdose	-2.6 beats per minute Standard Error 1.86	-2.6 beats per minute Standard Error 2.04	0.1 beats per minute Standard Error 2.07	0.0 beats per minute Standard Error 2.04	0.6 beats per minute Standard Error 2.04	0.0 beats per minute Standard Error 2.04	—	—	—
Part 1: Placebo-corrected Change From Baseline in Heart Rate 2 hours postdose	-2.1 beats per minute Standard Error 2.06	-2.7 beats per minute Standard Error 2.26	-2.0 beats per minute Standard Error 2.28	-1.3 beats per minute Standard Error 2.26	0.9 beats per minute Standard Error 2.26	0.1 beats per minute Standard Error 2.26	—	—	—
Part 1: Placebo-corrected Change From Baseline in Heart Rate 2.5 hours postdose	-3.0 beats per minute Standard Error 2.03	-2.0 beats per minute Standard Error 2.22	-3.8 beats per minute Standard Error 2.25	-1.5 beats per minute Standard Error 2.22	2.0 beats per minute Standard Error 2.22	-1.5 beats per minute Standard Error 2.22	—	—	—
Part 1: Placebo-corrected Change From Baseline in Heart Rate 3 hours postdose	-1.2 beats per minute Standard Error 2.18	-2.1 beats per minute Standard Error 2.39	-0.7 beats per minute Standard Error 2.41	-0.8 beats per minute Standard Error 2.39	2.9 beats per minute Standard Error 2.39	0.4 beats per minute Standard Error 2.39	—	—	—
Part 1: Placebo-corrected Change From Baseline in Heart Rate 4 hours postdose	-3.1 beats per minute Standard Error 2.23	-1.4 beats per minute Standard Error 2.45	0.4 beats per minute Standard Error 2.47	0.6 beats per minute Standard Error 2.45	1.9 beats per minute Standard Error 2.45	3.1 beats per minute Standard Error 2.45	—	—	—
Part 1: Placebo-corrected Change From Baseline in Heart Rate 8 hours postdose	-1.7 beats per minute Standard Error 2.46	0.1 beats per minute Standard Error 2.70	-0.9 beats per minute Standard Error 2.72	0.3 beats per minute Standard Error 2.70	3.1 beats per minute Standard Error 2.70	2.0 beats per minute Standard Error 2.70	—	—	—
Part 1: Placebo-corrected Change From Baseline in Heart Rate 12 hours postdose	-1.5 beats per minute Standard Error 2.85	-1.6 beats per minute Standard Error 3.12	-0.7 beats per minute Standard Error 3.14	-0.3 beats per minute Standard Error 3.12	6.4 beats per minute Standard Error 3.12	0.7 beats per minute Standard Error 3.12	—	—	—
Part 1: Placebo-corrected Change From Baseline in Heart Rate 24 hours postdose	-1.9 beats per minute Standard Error 2.60	-2.2 beats per minute Standard Error 2.85	-0.9 beats per minute Standard Error 2.87	0.4 beats per minute Standard Error 2.85	-0.1 beats per minute Standard Error 2.85	2.9 beats per minute Standard Error 3.06	—	—	—

SECONDARY outcome

Timeframe: Day 1: Predose at 3 time points (-45, -30 and -15 minutes), and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose.

Population: The QT/QTc population with available data at each time point. The number of participants analyzed includes participants in each S-648414 group with available data; reported values are corrected for placebo data collected for the 12 participants in the Part 1 Placebo group.

Continuous 12-lead digital electrocardiogram (ECG) recording was performed on Day 1. ECGs were analyzed at a blinded, central ECG laboratory. At each specified time point, ten 14-second 12-lead ECG tracings were extracted from the continuous recordings. The median PR interval in each replicate was calculated; the mean of available medians was used as the participant's reportable value at that time point.

Baseline was defined as the average of the measured ECG intervals from the 3 pre-dose time points (45, 30, and 15 minutes before dosing) on Day 1.

Change from Baseline (ΔPR) was calculated based on a linear mixed-effects model with time (categorical), treatment, and time-by-treatment interaction as fixed effects and Baseline PR as covariate.

Placebo-corrected ΔPR (ΔΔPR) was calculated as the adjusted mean ΔPR in the S-648414 group minus adjusted mean ΔPR in the placebo group at each time point.

Outcome measures

Measure	Part 3: 200 mg S-648414 n=8 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=6 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=6 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=6 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted n=6 Participants Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed n=6 Participants Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 1: Placebo-corrected Change From Baseline in PR Interval 0.5 hours postdose	-0.5 ms Standard Error 2.06	0.6 ms Standard Error 2.28	1.8 ms Standard Error 2.24	0.9 ms Standard Error 2.25	-4.3 ms Standard Error 2.25	-0.4 ms Standard Error 2.24	—	—	—
Part 1: Placebo-corrected Change From Baseline in PR Interval 1 hour postdose	0.5 ms Standard Error 2.05	0.2 ms Standard Error 2.27	3.2 ms Standard Error 2.23	1.0 ms Standard Error 2.24	-7.2 ms Standard Error 2.23	0.2 ms Standard Error 2.23	—	—	—
Part 1: Placebo-corrected Change From Baseline in PR Interval 1.5 hours postdose	0.5 ms Standard Error 2.76	3.0 ms Standard Error 3.04	0.6 ms Standard Error 3.02	1.8 ms Standard Error 3.02	0.4 ms Standard Error 3.02	0.5 ms Standard Error 3.02	—	—	—
Part 1: Placebo-corrected Change From Baseline in PR Interval 2 hours postdose	-3.1 ms Standard Error 2.29	2.0 ms Standard Error 2.52	2.6 ms Standard Error 2.49	-2.2 ms Standard Error 2.50	-2.9 ms Standard Error 2.49	-0.6 ms Standard Error 2.49	—	—	—
Part 1: Placebo-corrected Change From Baseline in PR Interval 2.5 hours postdose	-0.8 ms Standard Error 2.54	0.4 ms Standard Error 2.79	3.8 ms Standard Error 2.77	-0.2 ms Standard Error 2.78	-5.9 ms Standard Error 2.77	-1.6 ms Standard Error 2.77	—	—	—
Part 1: Placebo-corrected Change From Baseline in PR Interval 3 hours postdose	1.8 ms Standard Error 2.96	3.8 ms Standard Error 3.25	3.8 ms Standard Error 3.23	-1.4 ms Standard Error 3.24	-5.2 ms Standard Error 3.23	-0.5 ms Standard Error 3.23	—	—	—
Part 1: Placebo-corrected Change From Baseline in PR Interval 4 hours postdose	-1.5 ms Standard Error 2.65	2.5 ms Standard Error 2.91	2.7 ms Standard Error 2.89	-0.5 ms Standard Error 2.90	-7.4 ms Standard Error 2.89	-2.2 ms Standard Error 2.89	—	—	—
Part 1: Placebo-corrected Change From Baseline in PR Interval 6 hours postdose	0.5 ms Standard Error 2.48	1.2 ms Standard Error 2.74	3.5 ms Standard Error 2.71	1.9 ms Standard Error 2.72	-4.1 ms Standard Error 2.71	-0.1 ms Standard Error 2.71	—	—	—
Part 1: Placebo-corrected Change From Baseline in PR Interval 8 hours postdose	-1.3 ms Standard Error 3.01	1.4 ms Standard Error 3.31	6.8 ms Standard Error 3.28	-2.6 ms Standard Error 3.29	-2.6 ms Standard Error 3.29	1.4 ms Standard Error 3.29	—	—	—
Part 1: Placebo-corrected Change From Baseline in PR Interval 12 hours postdose	-0.4 ms Standard Error 3.37	1.3 ms Standard Error 3.70	4.5 ms Standard Error 3.68	-0.1 ms Standard Error 3.69	-6.9 ms Standard Error 3.68	0.4 ms Standard Error 3.68	—	—	—
Part 1: Placebo-corrected Change From Baseline in PR Interval 24 hours postdose	2.0 ms Standard Error 2.56	1.6 ms Standard Error 2.82	2.2 ms Standard Error 2.79	-2.7 ms Standard Error 2.80	-0.7 ms Standard Error 2.80	-1.6 ms Standard Error 2.99	—	—	—

SECONDARY outcome

Timeframe: Day 1: Predose at 3 time points (-45, -30 and -15 minutes), and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose.

Population: The QT/QTc population with available data at each time point. The number of participants analyzed includes participants in each S-648414 group with available data; reported values are corrected for placebo data collected for the 12 participants in the Part 1 Placebo group.

Continuous 12-lead digital electrocardiogram (ECG) recording was performed on Day 1. ECGs were analyzed at a blinded, central ECG laboratory. At each specified time point, ten 14-second 12-lead ECG tracings were extracted from the continuous recordings. The median QRS duration in each replicate was calculated; the mean of available medians was used as the participant's reportable value at that time point.

Baseline was defined as the average of the measured ECG intervals from the 3 pre-dose time points (45, 30, and 15 minutes before dosing) on Day 1.

Change from Baseline in QRS duration (ΔQRS) was calculated based on a linear mixed-effects model with time (categorical), treatment, and time-by-treatment interaction as fixed effects and Baseline QRS as covariate.

Placebo-corrected ΔQRS (ΔΔQRS) was calculated as the adjusted mean ΔQRS in the S-648414 group minus adjusted mean ΔQRS in the placebo group at each time point.

Outcome measures

Measure	Part 3: 200 mg S-648414 n=8 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=6 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=6 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=6 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted n=6 Participants Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed n=6 Participants Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 1: Placebo-corrected Change From Baseline in QRS Duration 4 hours postdose	0.3 ms Standard Error 0.46	-0.3 ms Standard Error 0.50	0.0 ms Standard Error 0.50	0.1 ms Standard Error 0.50	0.8 ms Standard Error 0.50	0.8 ms Standard Error 0.50	—	—	—
Part 1: Placebo-corrected Change From Baseline in QRS Duration 0.5 hours postdose	0.5 ms Standard Error 0.34	0.2 ms Standard Error 0.37	-0.1 ms Standard Error 0.37	0.2 ms Standard Error 0.37	0.4 ms Standard Error 0.37	0.2 ms Standard Error 0.37	—	—	—
Part 1: Placebo-corrected Change From Baseline in QRS Duration 1 hour postdose	0.6 ms Standard Error 0.35	0.3 ms Standard Error 0.39	0.5 ms Standard Error 0.39	0.7 ms Standard Error 0.39	0.6 ms Standard Error 0.39	0.8 ms Standard Error 0.39	—	—	—
Part 1: Placebo-corrected Change From Baseline in QRS Duration 1.5 hours postdose	-0.1 ms Standard Error 0.71	-0.7 ms Standard Error 0.77	-0.6 ms Standard Error 0.77	-0.1 ms Standard Error 0.77	-0.3 ms Standard Error 0.77	0.0 ms Standard Error 0.77	—	—	—
Part 1: Placebo-corrected Change From Baseline in QRS Duration 2 hours postdose	1.1 ms Standard Error 0.38	0.5 ms Standard Error 0.42	0.4 ms Standard Error 0.42	0.5 ms Standard Error 0.42	0.7 ms Standard Error 0.42	1.1 ms Standard Error 0.42	—	—	—
Part 1: Placebo-corrected Change From Baseline in QRS Duration 2.5 hours postdose	-0.1 ms Standard Error 0.38	0.1 ms Standard Error 0.42	0.3 ms Standard Error 0.42	0.3 ms Standard Error 0.42	0.1 ms Standard Error 0.42	0.4 ms Standard Error 0.42	—	—	—
Part 1: Placebo-corrected Change From Baseline in QRS Duration 3 hours postdose	0.3 ms Standard Error 0.35	0.2 ms Standard Error 0.38	0.4 ms Standard Error 0.38	0.5 ms Standard Error 0.38	0.5 ms Standard Error 0.38	0.3 ms Standard Error 0.38	—	—	—
Part 1: Placebo-corrected Change From Baseline in QRS Duration 6 hours postdose	-0.2 ms Standard Error 0.87	-0.3 ms Standard Error 0.95	0.0 ms Standard Error 0.95	-0.8 ms Standard Error 0.95	1.1 ms Standard Error 0.95	1.3 ms Standard Error 0.95	—	—	—
Part 1: Placebo-corrected Change From Baseline in QRS Duration 8 hours postdose	0.5 ms Standard Error 0.53	0.2 ms Standard Error 0.58	0.7 ms Standard Error 0.58	0.5 ms Standard Error 0.58	1.1 ms Standard Error 0.58	0.3 ms Standard Error 0.58	—	—	—
Part 1: Placebo-corrected Change From Baseline in QRS Duration 12 hours postdose	1.1 ms Standard Error 0.60	1.4 ms Standard Error 0.66	1.4 ms Standard Error 0.66	1.1 ms Standard Error 0.66	1.9 ms Standard Error 0.66	1.9 ms Standard Error 0.66	—	—	—
Part 1: Placebo-corrected Change From Baseline in QRS Duration 24 hours postdose	1.1 ms Standard Error 0.62	0.8 ms Standard Error 0.68	0.8 ms Standard Error 0.67	0.6 ms Standard Error 0.68	0.7 ms Standard Error 0.67	0.0 ms Standard Error 0.75	—	—	—

SECONDARY outcome

Timeframe: Day 1: Predose at 3 time points (-45, -30 and -15 minutes), and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose.

Population: QT/QTc population

A participant was determined as an outlier if the following criteria (assessed separately) were met for the ECG intervals at any time point:

QTcF:

• Treatment-emergent value of > 450 and ≤ 480 ms when not present at Baseline (new onset)
• Treatment-emergent value of > 480 and ≤ 500 ms when not present at Baseline (new onset)
• Treatment-emergent value of > 500 ms when not present at Baseline (new onset)
• Increase of QTcF (ΔQTcF) from Baseline of > 30 and ≤ 60 ms
• Increase of QTcF from Baseline > 60 ms

HR:

• Decrease of HR from Baseline > 25% resulting in HR < 50 bpm
• Increase of HR from Baseline > 25% resulting in HR > 100 bpm

PR:

• Increase of PR from Baseline > 25% resulting in PR > 200 ms

QRS:

• Increase of QRS from Baseline > 25% resulting in QRS > 120 ms

Outcome measures

Measure	Part 3: 200 mg S-648414 n=6 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=12 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=6 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=8 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted n=6 Participants Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed n=6 Participants Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 n=6 Participants Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 1: Number of Participants With Recorded Outlier Values for QTcF, HR, PR, and QRS QTcF > 450 and ≤ 480 ms	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Part 1: Number of Participants With Recorded Outlier Values for QTcF, HR, PR, and QRS QTcF > 480 and ≤ 500 ms	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Part 1: Number of Participants With Recorded Outlier Values for QTcF, HR, PR, and QRS QTcF > 500 ms	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Part 1: Number of Participants With Recorded Outlier Values for QTcF, HR, PR, and QRS ΔQTcF > 30 and ≤ 60 ms	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Part 1: Number of Participants With Recorded Outlier Values for QTcF, HR, PR, and QRS ΔQTcF > 60 ms	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Part 1: Number of Participants With Recorded Outlier Values for QTcF, HR, PR, and QRS HR < 50 (bpm) with a decrease in ΔHR > 25%	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Part 1: Number of Participants With Recorded Outlier Values for QTcF, HR, PR, and QRS HR > 100 (bpm) with an increase in ΔHR > 25%	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Part 1: Number of Participants With Recorded Outlier Values for QTcF, HR, PR, and QRS PR > 200 (ms) with an increase in ΔPR > 25%	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Part 1: Number of Participants With Recorded Outlier Values for QTcF, HR, PR, and QRS QRS > 120 (ms) with an increase in ΔQRS > 25%	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Day 1: Predose at 3 time points (-45, -30 and -15 minutes), and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose.

Population: QT/QTc population)

T-wave abnormalities were categorized as follows:

• Normal T wave: Any positive T wave not meeting any criterion below
• Flat T wave: T amplitude < 1 mm (either positive or negative) including flat isoelectric line
• Notched T wave (+): Presence of notch(es) of at least 0.05 mV amplitude on ascending or descending arm of the positive T wave
• Biphasic: T wave that contains a second component with an opposite phase that is at least 0.1 mV deep (both positive/negative and negative/positive and polyphasic T waves included)
• Normal T wave (-): T amplitude that is negative, without biphasic T wave or notches
• Notched T wave (-): Presence of notch(es) of at least 0.05 mV amplitude on descending or ascending arm of the negative T wave
• U waves: Presence of abnormal U waves

Outcome measures

Measure	Part 3: 200 mg S-648414 n=6 Participants Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 1: Placebo - Fasted n=12 Participants Participants received a single oral dose of matching placebo to S-648414 in a fasted state on Day 1.	Part 1: Placebo - Fed n=6 Participants Participants received a single dose of matching placebo to S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 30 mg S-648414 n=8 Participants Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted n=6 Participants Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed n=6 Participants Participants received a single dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 n=6 Participants Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.
Part 1: Number of Participants With Treatment-emergent Changes for T-wave Morphology and U-wave Presence Flat	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Part 1: Number of Participants With Treatment-emergent Changes for T-wave Morphology and U-wave Presence Notched (+)	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Part 1: Number of Participants With Treatment-emergent Changes for T-wave Morphology and U-wave Presence Biphasic	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Part 1: Number of Participants With Treatment-emergent Changes for T-wave Morphology and U-wave Presence Normal (-)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Part 1: Number of Participants With Treatment-emergent Changes for T-wave Morphology and U-wave Presence Notched (-)	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Part 1: Number of Participants With Treatment-emergent Changes for T-wave Morphology and U-wave Presence U-Wave presence	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—

Adverse Events

Part 1: Placebo - Fasted

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 1: Placebo - Fed

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 1: 10 mg S-648414

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 1: 30 mg S-648414

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 1: 100 mg S-648414 Fasted

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 1: 100 mg S-648414 Fed

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 1: 250 mg S-648414

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 1: 500 mg S-648414

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 1: 1000 mg S-648414

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 2: Midazolam (Day -2)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 2: Placebo (Days 1-13)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 2: 50 mg S-648414 (Days 1-13)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 2: 30 mg S-648414 (Days 1-13)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 2: Placebo + Midazolam (Day 14)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 2: 50 mg S-648414 + Midazolam (Day 14)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 2: 30 mg S-648414 + Midazolam (Day 14)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 3: Group I Dolutegravir

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 3: 100 mg S-648414

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 3: 100 mg S-648414 + Dolutegravir

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part 3: Dolutegravir

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 3: 200 mg S-648414

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Part 3: 200 mg S-648414 + Dolutegravir

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Part 1: Placebo - Fasted n=12 participants at risk Participants received a single oral dose of matching placebo in a fasted state on Day 1.	Part 1: Placebo - Fed n=2 participants at risk Participants received a single dose of matching placebo in a fed state (after a high-fat meal) on Day 14.	Part 1: 10 mg S-648414 n=6 participants at risk Participants received a single oral dose of 10 mg S-648414 in a fasted state on Day 1.	Part 1: 30 mg S-648414 n=6 participants at risk Participants received a single oral dose of 30 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fasted n=8 participants at risk Participants received a single oral dose of 100 mg S-648414 in a fasted state on Day 1.	Part 1: 100 mg S-648414 Fed n=8 participants at risk Participants received a single oral dose of 100 mg S-648414 in a fed state (after a high-fat meal) on Day 14.	Part 1: 250 mg S-648414 n=6 participants at risk Participants received a single oral dose of 250 mg S-648414 in a fasted state on Day 1.	Part 1: 500 mg S-648414 n=6 participants at risk Participants received a single oral dose of 500 mg S-648414 in a fasted state on Day 1.	Part 1: 1000 mg S-648414 n=6 participants at risk Participants received a single oral dose of 1000 mg S-648414 in a fasted state on Day 1.	Part 2: Midazolam (Day -2) n=20 participants at risk Participants received a single oral dose of 5 mg midazolam on Day -2	Part 2: Placebo (Days 1-13) n=4 participants at risk Participants received matching placebo to S-648414 once a day on Days 1 to 13.	Part 2: 50 mg S-648414 (Days 1-13) n=8 participants at risk Participants received 50 mg S-648414 once a day on Days 1 to 13.	Part 2: 30 mg S-648414 (Days 1-13) n=8 participants at risk Participants received 30 mg S-648414 once a day on Days 1 to 13.	Part 2: Placebo + Midazolam (Day 14) n=2 participants at risk Participants received matching placebo to S-648414 and a single oral dose of 5 mg midazolam on Day 14.	Part 2: 50 mg S-648414 + Midazolam (Day 14) n=7 participants at risk Participants received 50 mg S-648414 and a single oral dose of 5 mg midazolam on Day 14.	Part 2: 30 mg S-648414 + Midazolam (Day 14) n=8 participants at risk Participants received 30 mg S-648414 and a single oral dose of 5 mg midazolam on Day 14.	Part 3: Group I Dolutegravir n=14 participants at risk Participants received 50 mg dolutegravir orally once a day on Days 1 to 7.	Part 3: 100 mg S-648414 n=14 participants at risk Participants received 100 mg S-648414 orally once a day on Days 15 to 21.	Part 3: 100 mg S-648414 + Dolutegravir n=14 participants at risk Participants received 50 mg dolutegravir co-administered with 100 mg S-648414 orally once a day on Days 22 to 28.	Part 3: Dolutegravir n=14 participants at risk Participants received 50 mg dolutegravir once a day on Days 1 to 7.	Part 3: 200 mg S-648414 n=14 participants at risk Participants received 200 mg S-648414 orally once a day on Days 15 to 21.	Part 3: 200 mg S-648414 + Dolutegravir n=14 participants at risk Participants received 50 mg dolutegravir once a day co-administered with 200 mg S-648414 orally once a day on Days 22 to 28.
Investigations Blood creatine phosphokinase increased	0.00% 0/12 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	12.5% 1/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/20 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/4 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/7 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	7.1% 1/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/12 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/20 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/4 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	14.3% 1/7 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.
Gastrointestinal disorders Nausea	0.00% 0/12 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	12.5% 1/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	12.5% 1/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	16.7% 1/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/20 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/4 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/7 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/12 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	16.7% 1/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/20 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/4 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/7 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.
Gastrointestinal disorders Abdominal distension	8.3% 1/12 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/20 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/4 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/7 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.
Gastrointestinal disorders Aphthous ulcer	8.3% 1/12 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/20 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/4 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/7 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.
Gastrointestinal disorders Diarrhoea	0.00% 0/12 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	16.7% 1/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/20 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/4 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/7 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	7.1% 1/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.
Gastrointestinal disorders Vomiting	0.00% 0/12 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	12.5% 1/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	12.5% 1/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/20 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/4 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/7 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.
Investigations C-reactive protein increased	0.00% 0/12 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	12.5% 1/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/20 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/4 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/7 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.
Nervous system disorders Headache	0.00% 0/12 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	12.5% 1/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	12.5% 1/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	16.7% 1/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/20 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/4 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	12.5% 1/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	12.5% 1/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/7 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	7.1% 1/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	21.4% 3/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	14.3% 2/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	7.1% 1/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	7.1% 1/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.
Respiratory, thoracic and mediastinal disorders Allergic cough	0.00% 0/12 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	16.7% 1/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/20 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/4 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/7 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/12 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	12.5% 1/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/20 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/4 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/7 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/12 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	16.7% 1/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/20 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/4 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/7 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/12 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	16.7% 1/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/20 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/4 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/7 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.
Infections and infestations Upper respiratory tract infection	0.00% 0/12 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	12.5% 1/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/20 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/4 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/7 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/12 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	16.7% 1/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/20 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/4 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/7 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/12 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	16.7% 1/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/20 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/4 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/7 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.
Eye disorders Abnormal sensation in eye	0.00% 0/12 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/20 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/4 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	12.5% 1/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/7 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.
Eye disorders Dry eye	0.00% 0/12 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/20 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/4 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	12.5% 1/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/7 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	14.3% 2/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.
Eye disorders Eye pain	0.00% 0/12 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/20 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/4 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	12.5% 1/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/7 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.
Eye disorders Iritis	0.00% 0/12 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/20 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	25.0% 1/4 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/7 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.
Eye disorders Vision blurred	0.00% 0/12 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/20 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/4 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	12.5% 1/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/7 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/12 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/20 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/4 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	12.5% 1/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	25.0% 2/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/7 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/12 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/20 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/4 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	12.5% 1/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/7 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.
Nervous system disorders Dizziness	0.00% 0/12 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/20 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/4 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/7 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	12.5% 1/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.
Gastrointestinal disorders Abnormal faeces	0.00% 0/12 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/20 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/4 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	12.5% 1/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/7 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.
Immune system disorders Drug hypersensitivity	0.00% 0/12 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/20 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	25.0% 1/4 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/7 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/12 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/20 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/4 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	12.5% 1/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/7 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.
Musculoskeletal and connective tissue disorders Temporomandibular joint syndrome	0.00% 0/12 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/20 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/4 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	12.5% 1/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/7 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.
Psychiatric disorders Anxiety	0.00% 0/12 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/20 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/4 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	12.5% 1/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/7 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.
Renal and urinary disorders Chromaturia	0.00% 0/12 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/20 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/4 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	12.5% 1/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	14.3% 1/7 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.
Renal and urinary disorders Micturition disorder	0.00% 0/12 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/20 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/4 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	12.5% 1/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	14.3% 1/7 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.
Renal and urinary disorders Urine odour abnormal	0.00% 0/12 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/20 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/4 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	12.5% 1/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/7 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.
Nervous system disorders Head discomfort	0.00% 0/12 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/20 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/4 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/7 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	7.1% 1/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.
Investigations Intraocular pressure increased	0.00% 0/12 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/20 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/4 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/7 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	7.1% 1/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/12 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/20 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/4 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/7 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	14.3% 2/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.
Gastrointestinal disorders Constipation	0.00% 0/12 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/20 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/4 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/7 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	14.3% 2/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	7.1% 1/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/12 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/20 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/4 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/7 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	7.1% 1/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/12 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/20 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/4 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/7 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	7.1% 1/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.
Skin and subcutaneous tissue disorders Rash	0.00% 0/12 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/6 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/20 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/4 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/2 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/7 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/8 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	7.1% 1/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.	0.00% 0/14 • Part 1: From dosing on Day 1 or Day 14 up to 10 days post dose; Part 2: From the first dose up to 10 days after end of dosing (25 days); Part 3: From the first dose up to Day 36. A TEAE was summarized to a given treatment if the event onset/worsening occurred any time after the dose of that treatment and before the dose of the next treatment.

Additional Information

Shionogi Clinical Trials Administrator

Shionogi Inc.

Phone: 800-849-9707

Email: shionogiclintrials-admin@shionogi.co.jp

Results disclosure agreements

• Principal investigator is a sponsor employee The sponsor can embargo results from a PI's center until the combined results from the completed study have been published in full or the sponsor confirms there will be no multicenter study publication. Results communications must be provided to the sponsor for review at least 60 days before submission for publication. By written request, the sponsor can extend the embargo up to an additional 60 days. The sponsor cannot require changes to scientific content and cannot further extend the embargo.
• Publication restrictions are in place

Restriction type: OTHER