Trial Outcomes & Findings for Phase 1 TAK-041 First-in-Human Safety, Tolerability, and Pharmacokinetics Study (NCT NCT02748694)

Last Updated: 2021-03-19

Results Overview

An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug or due to a study procedure; it did not necessarily have to have a causal relationship with this treatment. A TEAE was defined as an AE that occurred or worsened after receiving the first dose of study drug and within 6 weeks after the last dose of study drug. A TEAE may also have been a pre-treatment AE or a concurrent medical condition diagnosed before the date of first dose of study drug that increased in severity after the start of dosing.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

114 participants

Primary outcome timeframe

From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks)

Results posted on

2021-03-19

Participant Flow

Participants took part in the study at one investigative site in the United States from 09 May 2016 to 22 September 2019.

Healthy participants were enrolled in Parts 1 to 3 to receive TAK-041 or placebo in this study as a single-rising dose (SRD), multiple-rising dose (MRD) or to assess the effect of food on drug's bioavailability. Participants with stable schizophrenia received TAK-041 or placebo as an add-on therapy in Part 4.

Participant milestones

Participant milestones
Measure	Part 1 (SRD): Placebo Cohorts 1-5 TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the single-rising dose (SRD) period.	Part 1 (SRD): Cohort 1: TAK-041 5/20 mg TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period. Participants also received 20 mg, suspension, orally, once on Day 8 in the SRD period.	Part 1 (SRD): Cohort 2: TAK-041 10/40 mg TAK-041 10 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period. Participants also received 40 mg, suspension, orally, once on Day 8 in the SRD period.	Part 1 (SRD): Cohort 3: TAK-041 80 mg TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 2 (MRD): Placebo Cohorts 1-4 TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the multiple-rising dose (MRD) period.	Part 2 (MRD): Cohort 1: TAK-041 40/20 mg TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 2: TAK-041 80/40 mg TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 3: TAK-041 120/60 mg TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 4: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.	Part 3: RBA/Food Effect: Regimen B TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part 4: MRD: Placebo TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia	Part 4: MRD: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.
Overall Study STARTED	10	6	6	6	6	6	8	6	6	6	6	9	9	8	16
Overall Study COMPLETED	10	6	6	6	6	6	8	6	6	6	6	9	9	8	14
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1 (SRD): Placebo Cohorts 1-5 TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the single-rising dose (SRD) period.	Part 1 (SRD): Cohort 1: TAK-041 5/20 mg TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period. Participants also received 20 mg, suspension, orally, once on Day 8 in the SRD period.	Part 1 (SRD): Cohort 2: TAK-041 10/40 mg TAK-041 10 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period. Participants also received 40 mg, suspension, orally, once on Day 8 in the SRD period.	Part 1 (SRD): Cohort 3: TAK-041 80 mg TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 2 (MRD): Placebo Cohorts 1-4 TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the multiple-rising dose (MRD) period.	Part 2 (MRD): Cohort 1: TAK-041 40/20 mg TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 2: TAK-041 80/40 mg TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 3: TAK-041 120/60 mg TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 4: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.	Part 3: RBA/Food Effect: Regimen B TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part 4: MRD: Placebo TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia	Part 4: MRD: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.
Overall Study Voluntary Withdrawal	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2

Baseline Characteristics

Phase 1 TAK-041 First-in-Human Safety, Tolerability, and Pharmacokinetics Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1 (SRD): Placebo Cohorts 1-5 n=10 Participants TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 1: TAK-041 5/20 mg n=6 Participants TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period. Participants also received 20 mg, suspension, orally, once on Day 8 in the SRD period.	Part 1 (SRD): Cohort 2: TAK-041 10/40 mg n=6 Participants TAK-041 10 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period. Participants also received 40 mg, suspension, orally, once on Day 8 in the SRD period.	Part 1 (SRD): Cohort 3: TAK-041 80 mg n=6 Participants TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg n=6 Participants TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg n=6 Participants TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 2 (MRD): Placebo Cohorts 1-4 n=8 Participants TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the MRD period.	Part 2 (MRD): Cohort 1: TAK-041 40/20 mg n=6 Participants TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 2: TAK-041 80/40 mg n=6 Participants TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 3: TAK-041 120/60 mg n=6 Participants TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 4: TAK-041 160/80 mg n=6 Participants TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A n=9 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.	Part 3: RBA/Food Effect: Regimen B n=9 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part 4: MRD: Placebo n=8 Participants TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia	Part 4: MRD: TAK-041 160/80 mg n=16 Participants TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.	Total n=114 Participants Total of all reporting groups
Age, Continuous	40.6 years n=5 Participants	36.8 years n=7 Participants	29.3 years n=5 Participants	44.2 years n=4 Participants	42.3 years n=21 Participants	40.5 years n=8 Participants	35.5 years n=8 Participants	39.5 years n=24 Participants	38.3 years n=42 Participants	37.7 years n=42 Participants	42.5 years n=42 Participants	35.6 years n=42 Participants	34.1 years n=36 Participants	45.8 years n=36 Participants	44.3 years n=24 Participants	39.46 years n=135 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	2 Participants n=24 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	1 Participants n=36 Participants	2 Participants n=36 Participants	3 Participants n=24 Participants	24 Participants n=135 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	5 Participants n=8 Participants	7 Participants n=8 Participants	4 Participants n=24 Participants	5 Participants n=42 Participants	5 Participants n=42 Participants	5 Participants n=42 Participants	7 Participants n=42 Participants	8 Participants n=36 Participants	6 Participants n=36 Participants	13 Participants n=24 Participants	90 Participants n=135 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	2 Participants n=42 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	1 Participants n=36 Participants	1 Participants n=36 Participants	1 Participants n=24 Participants	22 Participants n=135 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants	3 Participants n=21 Participants	4 Participants n=8 Participants	7 Participants n=8 Participants	6 Participants n=24 Participants	4 Participants n=42 Participants	5 Participants n=42 Participants	4 Participants n=42 Participants	7 Participants n=42 Participants	8 Participants n=36 Participants	7 Participants n=36 Participants	15 Participants n=24 Participants	92 Participants n=135 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	2 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=36 Participants	0 Participants n=36 Participants	3 Participants n=24 Participants	12 Participants n=135 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	1 Participants n=135 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	0 Participants n=21 Participants	4 Participants n=8 Participants	3 Participants n=8 Participants	2 Participants n=24 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	2 Participants n=36 Participants	5 Participants n=36 Participants	8 Participants n=24 Participants	35 Participants n=135 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	5 Participants n=21 Participants	2 Participants n=8 Participants	5 Participants n=8 Participants	2 Participants n=24 Participants	3 Participants n=42 Participants	4 Participants n=42 Participants	5 Participants n=42 Participants	8 Participants n=42 Participants	4 Participants n=36 Participants	3 Participants n=36 Participants	5 Participants n=24 Participants	59 Participants n=135 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	7 Participants n=135 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants
Region of Enrollment United States	10 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	6 Participants n=8 Participants	8 Participants n=8 Participants	6 Participants n=24 Participants	6 Participants n=42 Participants	6 Participants n=42 Participants	6 Participants n=42 Participants	9 Participants n=42 Participants	9 Participants n=36 Participants	8 Participants n=36 Participants	16 Participants n=24 Participants	114 Participants n=135 Participants
Height	176.9 cm n=5 Participants	174.3 cm n=7 Participants	171.2 cm n=5 Participants	175.2 cm n=4 Participants	164.8 cm n=21 Participants	178.3 cm n=8 Participants	178.3 cm n=8 Participants	174.2 cm n=24 Participants	168.3 cm n=42 Participants	173.8 cm n=42 Participants	173.0 cm n=42 Participants	175.3 cm n=42 Participants	175.7 cm n=36 Participants	173.9 cm n=36 Participants	174.9 cm n=24 Participants	174.24 cm n=135 Participants
Weight	79.68 kg n=5 Participants	78.63 kg n=7 Participants	74.43 kg n=5 Participants	86.97 kg n=4 Participants	68.52 kg n=21 Participants	89.83 kg n=8 Participants	81.79 kg n=8 Participants	83.40 kg n=24 Participants	77.20 kg n=42 Participants	78.22 kg n=42 Participants	76.43 kg n=42 Participants	76.07 kg n=42 Participants	79.42 kg n=36 Participants	91.46 kg n=36 Participants	98.58 kg n=24 Participants	81.82 kg n=135 Participants
Body Mass Index (BMI)	25.47 kg/m^2 n=5 Participants	25.91 kg/m^2 n=7 Participants	25.43 kg/m^2 n=5 Participants	28.36 kg/m^2 n=4 Participants	25.28 kg/m^2 n=21 Participants	28.22 kg/m^2 n=8 Participants	25.80 kg/m^2 n=8 Participants	27.63 kg/m^2 n=24 Participants	27.14 kg/m^2 n=42 Participants	25.74 kg/m^2 n=42 Participants	25.44 kg/m^2 n=42 Participants	24.76 kg/m^2 n=42 Participants	25.68 kg/m^2 n=36 Participants	30.31 kg/m^2 n=36 Participants	32.05 kg/m^2 n=24 Participants	27.24 kg/m^2 n=135 Participants

PRIMARY outcome

Timeframe: From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks)

Population: Safety Set included all participants who were enrolled and received at least 1 dose of study drug.

Outcome measures

Outcome measures
Measure	Part 3: RBA/Food Effect: Regimen B n=6 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part3:RBA/Food Effect:Regimen C-Part 1 Cohort2,Part 2 Cohort 1 n=6 Participants Regimen C included participants from Part 1 Cohort 2 and Part 2 Cohort 1 who received TAK-041, 40 mg suspension, orally on Day 1 in fasted condition.	Part 1 (SRD): Cohort 1: TAK-041 5 mg n=10 Participants TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg n=6 Participants TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg n=6 Participants TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 3: TAK-041 80 mg n=6 Participants TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg n=6 Participants TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg n=6 Participants TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 2 (MRD): Placebo Cohorts 1-4 n=8 Participants TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the MRD period.	Part 2 (MRD): Cohort 1: TAK-041 40/20 mg n=6 Participants TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 2: TAK-041 80/40 mg n=6 Participants TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 3: TAK-041 120/60 mg n=6 Participants TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 4: TAK-041 160/80 mg n=6 Participants TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A n=9 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.	Part 3: RBA/Food Effect: Regimen B n=9 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part 4: MRD: Placebo n=8 Participants TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia	Part 4: MRD: TAK-041 160/80 mg n=16 Participants TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.
Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)	0 percentage of participants	0 percentage of participants	40.0 percentage of participants	0 percentage of participants	0 percentage of participants	33.3 percentage of participants	33.3 percentage of participants	33.3 percentage of participants	37.5 percentage of participants	66.7 percentage of participants	66.7 percentage of participants	50.0 percentage of participants	83.3 percentage of participants	11.1 percentage of participants	22.2 percentage of participants	75.0 percentage of participants	56.3 percentage of participants

PRIMARY outcome

Timeframe: From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks)

Population: Safety Set included all participants who were enrolled and received at least 1 dose of study drug.

Outcome measures

Outcome measures
Measure	Part 3: RBA/Food Effect: Regimen B n=6 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part3:RBA/Food Effect:Regimen C-Part 1 Cohort2,Part 2 Cohort 1 n=6 Participants Regimen C included participants from Part 1 Cohort 2 and Part 2 Cohort 1 who received TAK-041, 40 mg suspension, orally on Day 1 in fasted condition.	Part 1 (SRD): Cohort 1: TAK-041 5 mg n=10 Participants TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg n=6 Participants TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg n=6 Participants TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 3: TAK-041 80 mg n=6 Participants TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg n=6 Participants TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg n=6 Participants TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 2 (MRD): Placebo Cohorts 1-4 n=8 Participants TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the MRD period.	Part 2 (MRD): Cohort 1: TAK-041 40/20 mg n=6 Participants TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 2: TAK-041 80/40 mg n=6 Participants TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 3: TAK-041 120/60 mg n=6 Participants TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 4: TAK-041 160/80 mg n=6 Participants TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A n=9 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.	Part 3: RBA/Food Effect: Regimen B n=9 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part 4: MRD: Placebo n=8 Participants TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia	Part 4: MRD: TAK-041 160/80 mg n=16 Participants TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE)	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks)

Population: Safety Set included all participants who were enrolled and received at least 1 dose of study drug.

Clinical laboratory tests included serum chemistry, hematology and urinalysis. MAV criteria:Alanine aminotransferase(U/L) \>3 x upper limit of normal(ULN);albumin\<2.5g/dL,\<25g/L;alkaline phosphatase (U/L)\>3 x ULN; aspartate aminotransferase (U/L)\>3 x ULN;bicarbonate\<8.0 mmol/L; bilirubin\>2.0mg/dL, \>34.2 μmol/L;blood urea nitrogen\>30 mg/dL,\>10.7mmol/L;calcium\<7.0 mg/dL,\<1.75 mmol/L, \>11.5 mg/dL,\>2.88 mmol/L;chloride\<75 mmol/L,\>126 mmol/L;creatine kinase(U/L) \>5 xULN; creatinine\>2.0 mg/dL,\>177μmol/L;direct bilirubin\>2 x ULN;gamma glutamyl transferase (U/L)\>3 x ULN;glucose\<50 mg/dL,\<2.8 mmol/L,\>350 mg/dL,\>19.4 mmol/L;potassium\<3.0 mmol/L \>6.0 mmol/L; protein(g/L)\<0.8 x LLN \>1.2 x ULN;sodium\<130mmol/L \>150mmol/L;erythrocytes(10\^12erythrocytes/L) \<0.8 x LLN,\>1.2 x ULN;hematocrit(fraction of 1)\<0.8 x LLN,\>1.2xULN;hemoglobin(g/L)\<0.8 x LLN\>1.2 x ULN;leukocytes(10\^9 leukocytes/L)\<0.5 x LLN \>1.5 x ULN;platelets(10\^9 platelets/L)\<75-\>600. Categories with at least one participant are reported.

Outcome measures

Outcome measures
Measure	Part 3: RBA/Food Effect: Regimen B n=6 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part3:RBA/Food Effect:Regimen C-Part 1 Cohort2,Part 2 Cohort 1 n=6 Participants Regimen C included participants from Part 1 Cohort 2 and Part 2 Cohort 1 who received TAK-041, 40 mg suspension, orally on Day 1 in fasted condition.	Part 1 (SRD): Cohort 1: TAK-041 5 mg n=10 Participants TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg n=6 Participants TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg n=6 Participants TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 3: TAK-041 80 mg n=6 Participants TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg n=6 Participants TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg n=6 Participants TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 2 (MRD): Placebo Cohorts 1-4 n=8 Participants TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the MRD period.	Part 2 (MRD): Cohort 1: TAK-041 40/20 mg n=6 Participants TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 2: TAK-041 80/40 mg n=6 Participants TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 3: TAK-041 120/60 mg n=6 Participants TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 4: TAK-041 160/80 mg n=6 Participants TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A n=9 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.	Part 3: RBA/Food Effect: Regimen B n=9 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part 4: MRD: Placebo n=8 Participants TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia	Part 4: MRD: TAK-041 160/80 mg n=16 Participants TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.
Percentage of Participants With Markedly Abnormal Value (MAV) Criteria for Safety Laboratory Tests At Least Once Post-dose Aspartate Aminotransferase, > 3 x ULN	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	11.1 percentage of participants	0 percentage of participants	6.3 percentage of participants
Percentage of Participants With Markedly Abnormal Value (MAV) Criteria for Safety Laboratory Tests At Least Once Post-dose Leukocytes, > 1.5 x ULN	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	6.3 percentage of participants
Percentage of Participants With Markedly Abnormal Value (MAV) Criteria for Safety Laboratory Tests At Least Once Post-dose Creatine Kinase, > 5 x ULN	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	12.5 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	11.1 percentage of participants	0 percentage of participants	12.5 percentage of participants
Percentage of Participants With Markedly Abnormal Value (MAV) Criteria for Safety Laboratory Tests At Least Once Post-dose Glucose < 50 mg/dL, < 2.8 mmol/L	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Value (MAV) Criteria for Safety Laboratory Tests At Least Once Post-dose Platelets, > 600 10^9 platelets/L	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	6.3 percentage of participants

PRIMARY outcome

Timeframe: From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks)

Population: Safety Set included all participants who were enrolled and received at least 1 dose of study drug.

Vital signs included oral body temperature measurement, supine and standing blood pressure, respiration rate, and pulse. Pulse and blood pressure was measured after 5 minutes supine and again at 1 and 3 minutes after standing. The markedly abnormal value (MAV) criteria for vital signs included systolic blood pressure \< 85 mmHg, \> 180 mmHg; diastolic blood pressure \< 50 mmHg, \> 110 mmHg; pulse \< 50 beats/min, \> 120 beats/min; temperature \< 35.6 C \> 37.7 C. Categories with data in at least one arm group are reported.

Outcome measures

Outcome measures
Measure	Part 3: RBA/Food Effect: Regimen B n=6 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part3:RBA/Food Effect:Regimen C-Part 1 Cohort2,Part 2 Cohort 1 n=6 Participants Regimen C included participants from Part 1 Cohort 2 and Part 2 Cohort 1 who received TAK-041, 40 mg suspension, orally on Day 1 in fasted condition.	Part 1 (SRD): Cohort 1: TAK-041 5 mg n=10 Participants TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg n=6 Participants TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg n=6 Participants TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 3: TAK-041 80 mg n=6 Participants TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg n=6 Participants TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg n=6 Participants TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 2 (MRD): Placebo Cohorts 1-4 n=8 Participants TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the MRD period.	Part 2 (MRD): Cohort 1: TAK-041 40/20 mg n=6 Participants TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 2: TAK-041 80/40 mg n=6 Participants TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 3: TAK-041 120/60 mg n=6 Participants TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 4: TAK-041 160/80 mg n=6 Participants TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A n=9 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.	Part 3: RBA/Food Effect: Regimen B n=9 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part 4: MRD: Placebo n=8 Participants TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia	Part 4: MRD: TAK-041 160/80 mg n=16 Participants TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.
Percentage of Participants With Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose Systolic Blood Pressure, Standing, < 85 mmHg	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	12.5 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose Diastolic Blood Pressure,3 min Standing,>110 mmHg	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	12.5 percentage of participants	6.3 percentage of participants
Percentage of Participants With Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose Temperature, < 35.6 C	0 percentage of participants	0 percentage of participants	20.0 percentage of participants	0 percentage of participants	0 percentage of participants	33.3 percentage of participants	16.7 percentage of participants	33.3 percentage of participants	37.5 percentage of participants	33.3 percentage of participants	16.7 percentage of participants	16.7 percentage of participants	33.3 percentage of participants	11.1 percentage of participants	0 percentage of participants	25.0 percentage of participants	31.3 percentage of participants
Percentage of Participants With Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose Systolic Blood Pressure, 5 min Supine, < 85 mmHg	0 percentage of participants	0 percentage of participants	10.0 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	12.5 percentage of participants	6.3 percentage of participants
Percentage of Participants With Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose Diastolic Blood Pressure,1 min Standing,>110 mmHg	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	6.3 percentage of participants
Percentage of Participants With Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose Pulse Rate, 1 min Standing, < 50 beats/min	0 percentage of participants	0 percentage of participants	10.0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	33.3 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose Pulse Rate, 1 min Standing, > 120 beats/min	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	33.3 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	25.0 percentage of participants	12.5 percentage of participants
Percentage of Participants With Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose Pulse Rate, 3 min Standing, < 50 beats/min	0 percentage of participants	0 percentage of participants	10.0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	33.3 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose Pulse Rate, 3 min Standing, > 120 beats/min	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	33.3 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	25.0 percentage of participants	12.5 percentage of participants
Percentage of Participants With Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose Systolic Blood Pressure, Supine, < 85 mmHg	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose Pulse Rate, Standing, < 50 beats/min	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose Pulse Rate, Standing, > 120 beats/min	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	6.3 percentage of participants
Percentage of Participants With Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose Systolic Blood Pressure, 1 min Standing, < 85 mmHg	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	12.5 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose Systolic Blood Pressure, 3 min Standing, < 85 mmHg	0 percentage of participants	0 percentage of participants	10.0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	12.5 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose Diastolic Blood Pressure, 5 min Supine, < 50 mmHg	0 percentage of participants	0 percentage of participants	10.0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	11.1 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose Pulse Rate, Supine, < 50 beats/min	0 percentage of participants	0 percentage of participants	10.0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	12.5 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose Pulse Rate, 5 min Supine, < 50 beats/min	16.7 percentage of participants	33.3 percentage of participants	50.0 percentage of participants	33.3 percentage of participants	33.3 percentage of participants	16.7 percentage of participants	33.3 percentage of participants	50.0 percentage of participants	62.5 percentage of participants	33.3 percentage of participants	16.7 percentage of participants	83.3 percentage of participants	33.3 percentage of participants	0 percentage of participants	33.3 percentage of participants	12.5 percentage of participants	12.5 percentage of participants

PRIMARY outcome

Timeframe: From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks)

Population: Safety Set included all participants who were enrolled and received at least 1 dose of study drug.

The markedly abnormal value (MAV) criteria for 12-lead ECG parameters included ECG Mean Heart Rate \< 50 beats/min, \> 120 beats/min; PR Interval, Aggregate \<= 80 msec, \>= 200 msec; QRS Duration, Aggregate \<= 80 msec, \>= 180 msec; QTcB Interval, Aggregate \<= 300 msec, \>= 500 msec OR (\>= 30 msec change from baseline and \>= 450 msec); QTcF Interval, Aggregate \<= 300 msec, \>= 500 msec OR (\>= 30 msec change from baseline and \>= 450 msec). Categories with data in at least one arm group are reported.

Outcome measures

Outcome measures
Measure	Part 3: RBA/Food Effect: Regimen B n=6 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part3:RBA/Food Effect:Regimen C-Part 1 Cohort2,Part 2 Cohort 1 n=6 Participants Regimen C included participants from Part 1 Cohort 2 and Part 2 Cohort 1 who received TAK-041, 40 mg suspension, orally on Day 1 in fasted condition.	Part 1 (SRD): Cohort 1: TAK-041 5 mg n=10 Participants TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg n=6 Participants TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg n=6 Participants TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 3: TAK-041 80 mg n=6 Participants TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg n=6 Participants TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg n=6 Participants TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 2 (MRD): Placebo Cohorts 1-4 n=8 Participants TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the MRD period.	Part 2 (MRD): Cohort 1: TAK-041 40/20 mg n=6 Participants TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 2: TAK-041 80/40 mg n=6 Participants TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 3: TAK-041 120/60 mg n=6 Participants TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 4: TAK-041 160/80 mg n=6 Participants TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A n=9 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.	Part 3: RBA/Food Effect: Regimen B n=9 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part 4: MRD: Placebo n=8 Participants TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia	Part 4: MRD: TAK-041 160/80 mg n=16 Participants TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.
Percentage of Participants With Markedly Abnormal Criteria for 12-Lead Electrocardiogram (ECG) Parameters at Least Once Post-dose ECG Mean Heart Rate, < 50 beats/min	16.7 percentage of participants	33.3 percentage of participants	20.0 percentage of participants	50.0 percentage of participants	33.3 percentage of participants	0 percentage of participants	16.7 percentage of participants	50.0 percentage of participants	37.5 percentage of participants	16.7 percentage of participants	16.7 percentage of participants	66.7 percentage of participants	33.3 percentage of participants	0 percentage of participants	22.2 percentage of participants	12.5 percentage of participants	12.5 percentage of participants
Percentage of Participants With Markedly Abnormal Criteria for 12-Lead Electrocardiogram (ECG) Parameters at Least Once Post-dose PR Interval, Aggregate, >= 200 msec	33.3 percentage of participants	33.3 percentage of participants	0 percentage of participants	33.3 percentage of participants	33.3 percentage of participants	16.7 percentage of participants	16.7 percentage of participants	0 percentage of participants	25.0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	11.1 percentage of participants	12.5 percentage of participants	12.5 percentage of participants
Percentage of Participants With Markedly Abnormal Criteria for 12-Lead Electrocardiogram (ECG) Parameters at Least Once Post-dose QTcB Interval, Aggregate, >= 500 msec	0 percentage of participants	0 percentage of participants	10.0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	6.3 percentage of participants
Percentage of Participants With Markedly Abnormal Criteria for 12-Lead Electrocardiogram (ECG) Parameters at Least Once Post-dose QTcF Interval, Aggregate, >= 500 msec	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Criteria for 12-Lead Electrocardiogram (ECG) Parameters at Least Once Post-dose QRS Duration, Aggregate, <= 80 msec	33.3 percentage of participants	50.0 percentage of participants	20.0 percentage of participants	33.3 percentage of participants	50.0 percentage of participants	33.3 percentage of participants	33.3 percentage of participants	16.7 percentage of participants	0 percentage of participants	33.3 percentage of participants	33.3 percentage of participants	66.7 percentage of participants	16.7 percentage of participants	33.3 percentage of participants	11.1 percentage of participants	75.0 percentage of participants	31.3 percentage of participants

PRIMARY outcome

Timeframe: Part 2: from first dose up to Day 66

Population: Safety Set included all participants who were enrolled and received at least 1 dose of study drug. Continuous 12-lead Holter ECG monitoring was performed in Part 2 only.

The markedly abnormal value (MAV) criteria for continuous 12-lead Holter ECG parameters included ECG Mean Heart Rate \< 50 beats/min, \> 120 beats/min; PR Interval, Aggregate \<= 80 msec, \>= 200 msec; QRS Duration, Aggregate \<= 80 msec, \>= 180 msec; QTcB Interval, Aggregate \<= 300 msec, \>= 500 msec OR (\>= 30 msec change from baseline and \>= 450 msec); QTcF Interval, Aggregate \<= 300 msec, \>= 500 msec OR (\>= 30 msec change from baseline and \>= 450 msec). Categories with data in at least one arm group are reported.

Outcome measures

Outcome measures
Measure	Part 3: RBA/Food Effect: Regimen B n=6 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part3:RBA/Food Effect:Regimen C-Part 1 Cohort2,Part 2 Cohort 1 n=6 Participants Regimen C included participants from Part 1 Cohort 2 and Part 2 Cohort 1 who received TAK-041, 40 mg suspension, orally on Day 1 in fasted condition.	Part 1 (SRD): Cohort 1: TAK-041 5 mg n=8 Participants TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg n=6 Participants TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg n=6 Participants TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 3: TAK-041 80 mg TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 2 (MRD): Placebo Cohorts 1-4 TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the MRD period.	Part 2 (MRD): Cohort 1: TAK-041 40/20 mg TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 2: TAK-041 80/40 mg TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 3: TAK-041 120/60 mg TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 4: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.	Part 3: RBA/Food Effect: Regimen B TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part 4: MRD: Placebo TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia	Part 4: MRD: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.
Part 2: Percentage of Participants Who Experienced Clinically Significant Abnormal Changes in Continuous 12-Lead Holter ECG Measurements at Least Once Post-Dose PR Interval, Aggregate, >= 200 msec	0 percentage of participants	0 percentage of participants	25.0 percentage of participants	0 percentage of participants	0 percentage of participants	—	—	—	—	—	—	—	—	—	—	—	—
Part 2: Percentage of Participants Who Experienced Clinically Significant Abnormal Changes in Continuous 12-Lead Holter ECG Measurements at Least Once Post-Dose QRS Duration, Aggregate, <= 80 msec	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	—	—	—	—	—	—	—	—	—	—	—	—
Part 2: Percentage of Participants Who Experienced Clinically Significant Abnormal Changes in Continuous 12-Lead Holter ECG Measurements at Least Once Post-Dose ECG Mean Heart Rate, < 50 beats/min	0 percentage of participants	0 percentage of participants	0 percentage of participants	50.0 percentage of participants	16.7 percentage of participants	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Part 3: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose

Population: Pharmacokinetic (PK) Set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. Data for Regimen C were combined from Part 1 Cohort 2 and Part 2 Cohort 1 (Day 1) to report RBA/food effect on suspension formulation.

Outcome measures

Outcome measures
Measure	Part 3: RBA/Food Effect: Regimen B n=9 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part3:RBA/Food Effect:Regimen C-Part 1 Cohort2,Part 2 Cohort 1 n=12 Participants Regimen C included participants from Part 1 Cohort 2 and Part 2 Cohort 1 who received TAK-041, 40 mg suspension, orally on Day 1 in fasted condition.	Part 1 (SRD): Cohort 1: TAK-041 5 mg n=9 Participants TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 3: TAK-041 80 mg TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 2 (MRD): Placebo Cohorts 1-4 TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the MRD period.	Part 2 (MRD): Cohort 1: TAK-041 40/20 mg TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 2: TAK-041 80/40 mg TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 3: TAK-041 120/60 mg TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 4: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.	Part 3: RBA/Food Effect: Regimen B TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part 4: MRD: Placebo TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia	Part 4: MRD: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.
Part 3: Cmax: Maximum Observed Plasma Concentration for TAK-041 in RBA/Food Effect Participants [Day 1]	838.3 ng/mL Standard Deviation 176.04	648.4 ng/mL Standard Deviation 158.67	715.4 ng/mL Standard Deviation 192.54	—	—	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Part 3: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose

Population: PK Set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. Data for Regimen C were combined from Part 1 Cohort 2 and Part 2 Cohort 1 (Day 1) to report RBA/food effect on suspension formulation.

Outcome measures

Outcome measures
Measure	Part 3: RBA/Food Effect: Regimen B n=9 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part3:RBA/Food Effect:Regimen C-Part 1 Cohort2,Part 2 Cohort 1 n=12 Participants Regimen C included participants from Part 1 Cohort 2 and Part 2 Cohort 1 who received TAK-041, 40 mg suspension, orally on Day 1 in fasted condition.	Part 1 (SRD): Cohort 1: TAK-041 5 mg n=9 Participants TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 3: TAK-041 80 mg TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 2 (MRD): Placebo Cohorts 1-4 TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the MRD period.	Part 2 (MRD): Cohort 1: TAK-041 40/20 mg TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 2: TAK-041 80/40 mg TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 3: TAK-041 120/60 mg TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 4: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.	Part 3: RBA/Food Effect: Regimen B TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part 4: MRD: Placebo TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia	Part 4: MRD: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.
Part 3: AUC96: Area Under the Plasma Concentration-Time Curve From Time 0 to 96 Hours (AUC96) for TAK-041 in RBA/Food Effect Participants [Day 1]	45499.1 h*ng/mL Standard Deviation 16007.58	37795.2 h*ng/mL Standard Deviation 5667.55	41564.5 h*ng/mL Standard Deviation 7713.08	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Part 1: Day 1 pre-dose and at multiple time points post dose, up to 96 hours for Cohorts 1 and 2; up to 168 hours for Cohorts 3-5

Population: PK Set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.

Outcome measures

Outcome measures
Measure	Part 3: RBA/Food Effect: Regimen B n=6 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part3:RBA/Food Effect:Regimen C-Part 1 Cohort2,Part 2 Cohort 1 n=6 Participants Regimen C included participants from Part 1 Cohort 2 and Part 2 Cohort 1 who received TAK-041, 40 mg suspension, orally on Day 1 in fasted condition.	Part 1 (SRD): Cohort 1: TAK-041 5 mg n=6 Participants TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg n=6 Participants TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg n=6 Participants TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 3: TAK-041 80 mg TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 2 (MRD): Placebo Cohorts 1-4 TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the MRD period.	Part 2 (MRD): Cohort 1: TAK-041 40/20 mg TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 2: TAK-041 80/40 mg TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 3: TAK-041 120/60 mg TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 4: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.	Part 3: RBA/Food Effect: Regimen B TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part 4: MRD: Placebo TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia	Part 4: MRD: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.
Part 1: Cmax: Maximum Observed Plasma Concentration for TAK-041 in SRD Participants [Day 1]	193.3 ng/mL Standard Deviation 27.75	909.5 ng/mL Standard Deviation 225.29	139.8 ng/mL Standard Deviation 15.25	1200.0 ng/mL Standard Deviation 147.38	1121.7 ng/mL Standard Deviation 175.31	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Part 1: Pre-dose on Day 8 and at multiple timepoints (Up to 96 hours) post-dose

Population: PK Set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.

Outcome measures

Outcome measures
Measure	Part 3: RBA/Food Effect: Regimen B n=6 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part3:RBA/Food Effect:Regimen C-Part 1 Cohort2,Part 2 Cohort 1 Regimen C included participants from Part 1 Cohort 2 and Part 2 Cohort 1 who received TAK-041, 40 mg suspension, orally on Day 1 in fasted condition.	Part 1 (SRD): Cohort 1: TAK-041 5 mg n=6 Participants TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 3: TAK-041 80 mg TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 2 (MRD): Placebo Cohorts 1-4 TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the MRD period.	Part 2 (MRD): Cohort 1: TAK-041 40/20 mg TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 2: TAK-041 80/40 mg TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 3: TAK-041 120/60 mg TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 4: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.	Part 3: RBA/Food Effect: Regimen B TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part 4: MRD: Placebo TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia	Part 4: MRD: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.
Part 1: Cmax: Maximum Observed Plasma Concentration for TAK-041 in SRD Participants [Day 8], Cohorts 1 (20 mg) and 2 (40 mg) Only	747.2 ng/mL Standard Deviation 103.22	—	450.5 ng/mL Standard Deviation 90.25	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Parts 2 and 4: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose

Population: PK Set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. Overall number of participants analyzed is the number of participants with data available for analyses.

Outcome measures

Outcome measures
Measure	Part 3: RBA/Food Effect: Regimen B n=6 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part3:RBA/Food Effect:Regimen C-Part 1 Cohort2,Part 2 Cohort 1 n=6 Participants Regimen C included participants from Part 1 Cohort 2 and Part 2 Cohort 1 who received TAK-041, 40 mg suspension, orally on Day 1 in fasted condition.	Part 1 (SRD): Cohort 1: TAK-041 5 mg n=6 Participants TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg n=6 Participants TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg n=15 Participants TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 3: TAK-041 80 mg TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 2 (MRD): Placebo Cohorts 1-4 TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the MRD period.	Part 2 (MRD): Cohort 1: TAK-041 40/20 mg TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 2: TAK-041 80/40 mg TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 3: TAK-041 120/60 mg TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 4: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.	Part 3: RBA/Food Effect: Regimen B TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part 4: MRD: Placebo TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia	Part 4: MRD: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.
Parts 2 and 4: Cmax: Maximum Observed Plasma Concentration for TAK-041 in MRD Participants [Day 1]	879.7 ng/mL Standard Deviation 217.95	1260.8 ng/mL Standard Deviation 265.22	549.7 ng/mL Standard Deviation 146.05	1760.0 ng/mL Standard Deviation 349.69	1266.5 ng/mL Standard Deviation 366.10	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Part 1: Day 1 pre-dose and at multiple time points post dose, up to 96 hours for Cohorts 1 and 2; up to 168 hours for Cohorts 3-5

Population: PK Set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.

Outcome measures

Outcome measures
Measure	Part 3: RBA/Food Effect: Regimen B n=6 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part3:RBA/Food Effect:Regimen C-Part 1 Cohort2,Part 2 Cohort 1 n=6 Participants Regimen C included participants from Part 1 Cohort 2 and Part 2 Cohort 1 who received TAK-041, 40 mg suspension, orally on Day 1 in fasted condition.	Part 1 (SRD): Cohort 1: TAK-041 5 mg n=6 Participants TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg n=6 Participants TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg n=6 Participants TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 3: TAK-041 80 mg TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 2 (MRD): Placebo Cohorts 1-4 TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the MRD period.	Part 2 (MRD): Cohort 1: TAK-041 40/20 mg TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 2: TAK-041 80/40 mg TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 3: TAK-041 120/60 mg TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 4: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.	Part 3: RBA/Food Effect: Regimen B TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part 4: MRD: Placebo TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia	Part 4: MRD: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.
Part 1: Tmax: Time to Reach the Cmax for TAK-041 in SRD Participants [Day 1]	1.742 hours Interval 1.03 to 2.0	3.000 hours Interval 1.0 to 48.02	0.992 hours Interval 0.48 to 3.0	13.017 hours Interval 1.5 to 96.05	13.517 hours Interval 1.98 to 71.97	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Part 1: Pre-dose on Day 8 and at multiple timepoints (Up to 96 hours) post-dose

Population: PK Set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.

Outcome measures

Outcome measures
Measure	Part 3: RBA/Food Effect: Regimen B n=6 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part3:RBA/Food Effect:Regimen C-Part 1 Cohort2,Part 2 Cohort 1 Regimen C included participants from Part 1 Cohort 2 and Part 2 Cohort 1 who received TAK-041, 40 mg suspension, orally on Day 1 in fasted condition.	Part 1 (SRD): Cohort 1: TAK-041 5 mg n=6 Participants TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 3: TAK-041 80 mg TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 2 (MRD): Placebo Cohorts 1-4 TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the MRD period.	Part 2 (MRD): Cohort 1: TAK-041 40/20 mg TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 2: TAK-041 80/40 mg TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 3: TAK-041 120/60 mg TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 4: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.	Part 3: RBA/Food Effect: Regimen B TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part 4: MRD: Placebo TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia	Part 4: MRD: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.
Part 1: Tmax: Time to Reach the Cmax for TAK-041 in SRD Participants [Day 8], Cohorts 1 (20 mg) and 2 (40 mg) Only	1.583 hours Interval 1.5 to 2.0	—	1.992 hours Interval 1.0 to 3.0	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Parts 2 and 4: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose

Outcome measures

Outcome measures
Measure	Part 3: RBA/Food Effect: Regimen B n=6 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part3:RBA/Food Effect:Regimen C-Part 1 Cohort2,Part 2 Cohort 1 n=6 Participants Regimen C included participants from Part 1 Cohort 2 and Part 2 Cohort 1 who received TAK-041, 40 mg suspension, orally on Day 1 in fasted condition.	Part 1 (SRD): Cohort 1: TAK-041 5 mg n=6 Participants TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg n=6 Participants TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg n=15 Participants TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 3: TAK-041 80 mg TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 2 (MRD): Placebo Cohorts 1-4 TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the MRD period.	Part 2 (MRD): Cohort 1: TAK-041 40/20 mg TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 2: TAK-041 80/40 mg TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 3: TAK-041 120/60 mg TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 4: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.	Part 3: RBA/Food Effect: Regimen B TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part 4: MRD: Placebo TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia	Part 4: MRD: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.
Parts 2 and 4: Tmax: Time to Reach the Cmax for TAK-041 in MRD Participants [Day 1]	1.525 hours Interval 1.5 to 3.05	2.500 hours Interval 1.5 to 47.88	2.517 hours Interval 0.97 to 4.0	3.000 hours Interval 1.5 to 95.77	2.000 hours Interval 1.0 to 96.8	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Part 3: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose

Outcome measures

Outcome measures
Measure	Part 3: RBA/Food Effect: Regimen B n=9 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part3:RBA/Food Effect:Regimen C-Part 1 Cohort2,Part 2 Cohort 1 n=12 Participants Regimen C included participants from Part 1 Cohort 2 and Part 2 Cohort 1 who received TAK-041, 40 mg suspension, orally on Day 1 in fasted condition.	Part 1 (SRD): Cohort 1: TAK-041 5 mg n=9 Participants TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 3: TAK-041 80 mg TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 2 (MRD): Placebo Cohorts 1-4 TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the MRD period.	Part 2 (MRD): Cohort 1: TAK-041 40/20 mg TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 2: TAK-041 80/40 mg TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 3: TAK-041 120/60 mg TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 4: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.	Part 3: RBA/Food Effect: Regimen B TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part 4: MRD: Placebo TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia	Part 4: MRD: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.
Part 3: Tmax: Time to Reach the Cmax for TAK-041 in RBA/Food Effect Participants [Day 1]	2.000 hours Interval 2.0 to 23.92	1.817 hours Interval 0.97 to 4.0	2.000 hours Interval 0.98 to 36.0	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Part 1: Day 1 pre-dose and at multiple time points post dose, up to 96 hours for Cohorts 1 and 2; up to 168 hours for Cohorts 3-5

Population: PK Set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.

Outcome measures

Outcome measures
Measure	Part 3: RBA/Food Effect: Regimen B n=6 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part3:RBA/Food Effect:Regimen C-Part 1 Cohort2,Part 2 Cohort 1 n=6 Participants Regimen C included participants from Part 1 Cohort 2 and Part 2 Cohort 1 who received TAK-041, 40 mg suspension, orally on Day 1 in fasted condition.	Part 1 (SRD): Cohort 1: TAK-041 5 mg n=6 Participants TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg n=6 Participants TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg n=6 Participants TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 3: TAK-041 80 mg TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 2 (MRD): Placebo Cohorts 1-4 TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the MRD period.	Part 2 (MRD): Cohort 1: TAK-041 40/20 mg TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 2: TAK-041 80/40 mg TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 3: TAK-041 120/60 mg TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 4: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.	Part 3: RBA/Food Effect: Regimen B TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part 4: MRD: Placebo TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia	Part 4: MRD: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.
Part 1: AUC24: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-041 in SRD Participants [Day 1]	2844.6 h*ng/mL Standard Deviation 263.78	15594.9 h*ng/mL Standard Deviation 5560.51	1662.3 h*ng/mL Standard Deviation 390.74	22471.2 h*ng/mL Standard Deviation 4340.25	21426.6 h*ng/mL Standard Deviation 6026.07	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Part 1: Pre-dose on Day 8 and at multiple timepoints (Up to 96 hours) post-dose

Population: PK Set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.

Outcome measures

Outcome measures
Measure	Part 3: RBA/Food Effect: Regimen B n=6 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part3:RBA/Food Effect:Regimen C-Part 1 Cohort2,Part 2 Cohort 1 Regimen C included participants from Part 1 Cohort 2 and Part 2 Cohort 1 who received TAK-041, 40 mg suspension, orally on Day 1 in fasted condition.	Part 1 (SRD): Cohort 1: TAK-041 5 mg n=6 Participants TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 3: TAK-041 80 mg TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 2 (MRD): Placebo Cohorts 1-4 TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the MRD period.	Part 2 (MRD): Cohort 1: TAK-041 40/20 mg TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 2: TAK-041 80/40 mg TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 3: TAK-041 120/60 mg TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 4: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.	Part 3: RBA/Food Effect: Regimen B TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part 4: MRD: Placebo TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia	Part 4: MRD: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.
Part 1: AUC24: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-041 in SRD Participants [Day 8], Cohorts 1 (20 mg) and 2 (40 mg) Only	11955.2 h*ng/mL Standard Deviation 1091.59	—	6399.5 h*ng/mL Standard Deviation 1809.44	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Parts 2 and 4: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose

Outcome measures

Outcome measures
Measure	Part 3: RBA/Food Effect: Regimen B n=6 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part3:RBA/Food Effect:Regimen C-Part 1 Cohort2,Part 2 Cohort 1 n=6 Participants Regimen C included participants from Part 1 Cohort 2 and Part 2 Cohort 1 who received TAK-041, 40 mg suspension, orally on Day 1 in fasted condition.	Part 1 (SRD): Cohort 1: TAK-041 5 mg n=6 Participants TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg n=6 Participants TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg n=15 Participants TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 3: TAK-041 80 mg TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 2 (MRD): Placebo Cohorts 1-4 TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the MRD period.	Part 2 (MRD): Cohort 1: TAK-041 40/20 mg TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 2: TAK-041 80/40 mg TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 3: TAK-041 120/60 mg TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 4: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.	Part 3: RBA/Food Effect: Regimen B TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part 4: MRD: Placebo TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia	Part 4: MRD: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.
Parts 2 and 4: AUC24: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-041 in MRD Participants [Day 1]	14556.7 h*ng/mL Standard Deviation 4317.73	22450.3 h*ng/mL Standard Deviation 3625.16	9188.0 h*ng/mL Standard Deviation 3095.87	28014.6 h*ng/mL Standard Deviation 7698.01	20400.8 h*ng/mL Standard Deviation 5096.46	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Part 3: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose

Outcome measures

Outcome measures
Measure	Part 3: RBA/Food Effect: Regimen B n=9 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part3:RBA/Food Effect:Regimen C-Part 1 Cohort2,Part 2 Cohort 1 n=12 Participants Regimen C included participants from Part 1 Cohort 2 and Part 2 Cohort 1 who received TAK-041, 40 mg suspension, orally on Day 1 in fasted condition.	Part 1 (SRD): Cohort 1: TAK-041 5 mg n=9 Participants TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 3: TAK-041 80 mg TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 2 (MRD): Placebo Cohorts 1-4 TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the MRD period.	Part 2 (MRD): Cohort 1: TAK-041 40/20 mg TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 2: TAK-041 80/40 mg TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 3: TAK-041 120/60 mg TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 4: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.	Part 3: RBA/Food Effect: Regimen B TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part 4: MRD: Placebo TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia	Part 4: MRD: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.
Part 3: AUC24: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-041 in RBA/Food Effect Participants [Day 1]	13827.9 h*ng/mL Standard Deviation 5143.36	10571.6 h*ng/mL Standard Deviation 2643.23	11940.8 h*ng/mL Standard Deviation 3052.59	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Part 1: Day 1 pre-dose and at multiple time points post dose, up to 96 hours for Cohorts 1 and 2; up to 168 hours for Cohorts 3-5

Population: PK Set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.

Outcome measures

Outcome measures
Measure	Part 3: RBA/Food Effect: Regimen B n=6 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part3:RBA/Food Effect:Regimen C-Part 1 Cohort2,Part 2 Cohort 1 n=6 Participants Regimen C included participants from Part 1 Cohort 2 and Part 2 Cohort 1 who received TAK-041, 40 mg suspension, orally on Day 1 in fasted condition.	Part 1 (SRD): Cohort 1: TAK-041 5 mg n=6 Participants TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg n=6 Participants TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg n=6 Participants TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 3: TAK-041 80 mg TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 2 (MRD): Placebo Cohorts 1-4 TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the MRD period.	Part 2 (MRD): Cohort 1: TAK-041 40/20 mg TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 2: TAK-041 80/40 mg TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 3: TAK-041 120/60 mg TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 4: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.	Part 3: RBA/Food Effect: Regimen B TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part 4: MRD: Placebo TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia	Part 4: MRD: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.
Part 1: AUC96: Area Under the Plasma Concentration-Time Curve From Time 0 to 96 Hours for TAK-041 in SRD Participants [Day 1]	9746.9 h*ng/mL Standard Deviation 781.89	59514.3 h*ng/mL Standard Deviation 14414.25	5237.2 h*ng/mL Standard Deviation 1107.97	92784.6 h*ng/mL Standard Deviation 13410.06	90585.1 h*ng/mL Standard Deviation 15742.96	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Part 1: Pre-dose on Day 8 and at multiple timepoints (Up to 96 hours) post-dose

Population: PK Set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.

Outcome measures

Outcome measures
Measure	Part 3: RBA/Food Effect: Regimen B n=6 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part3:RBA/Food Effect:Regimen C-Part 1 Cohort2,Part 2 Cohort 1 Regimen C included participants from Part 1 Cohort 2 and Part 2 Cohort 1 who received TAK-041, 40 mg suspension, orally on Day 1 in fasted condition.	Part 1 (SRD): Cohort 1: TAK-041 5 mg n=6 Participants TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 3: TAK-041 80 mg TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 2 (MRD): Placebo Cohorts 1-4 TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the MRD period.	Part 2 (MRD): Cohort 1: TAK-041 40/20 mg TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 2: TAK-041 80/40 mg TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 3: TAK-041 120/60 mg TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 4: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.	Part 3: RBA/Food Effect: Regimen B TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part 4: MRD: Placebo TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia	Part 4: MRD: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.
Part 1: AUC96: Area Under the Plasma Concentration-Time Curve From Time 0 to 96 Hours for TAK-041 in SRD Participants [Day 8], Cohorts 1 (20 mg) and 2 (40 mg) Only	40487.8 h*ng/mL Standard Deviation 3088.81	—	21180.0 h*ng/mL Standard Deviation 5680.75	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Parts 2 and 4: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose

Outcome measures

Outcome measures
Measure	Part 3: RBA/Food Effect: Regimen B n=6 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part3:RBA/Food Effect:Regimen C-Part 1 Cohort2,Part 2 Cohort 1 n=6 Participants Regimen C included participants from Part 1 Cohort 2 and Part 2 Cohort 1 who received TAK-041, 40 mg suspension, orally on Day 1 in fasted condition.	Part 1 (SRD): Cohort 1: TAK-041 5 mg n=6 Participants TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg n=6 Participants TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg n=15 Participants TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 3: TAK-041 80 mg TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 2 (MRD): Placebo Cohorts 1-4 TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the MRD period.	Part 2 (MRD): Cohort 1: TAK-041 40/20 mg TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 2: TAK-041 80/40 mg TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 3: TAK-041 120/60 mg TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 4: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.	Part 3: RBA/Food Effect: Regimen B TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part 4: MRD: Placebo TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia	Part 4: MRD: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.
Parts 2 and 4: AUC96: Area Under the Plasma Concentration-Time Curve From Time 0 to 96 Hours for TAK-041 in MRD Participants [Day 1]	60770.4 h*ng/mL Standard Deviation 15609.67	91712.9 h*ng/mL Standard Deviation 12328.54	35102.6 h*ng/mL Standard Deviation 6612.50	123645.0 h*ng/mL Standard Deviation 29616.79	90372.3 h*ng/mL Standard Deviation 22678.03	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Part 1: Day 1 pre-dose and at multiple time points post dose, up to 96 hours for Cohorts 1 and 2; up to 168 hours for Cohorts 3-5

Population: PK Set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.

Outcome measures

Outcome measures
Measure	Part 3: RBA/Food Effect: Regimen B n=6 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part3:RBA/Food Effect:Regimen C-Part 1 Cohort2,Part 2 Cohort 1 n=6 Participants Regimen C included participants from Part 1 Cohort 2 and Part 2 Cohort 1 who received TAK-041, 40 mg suspension, orally on Day 1 in fasted condition.	Part 1 (SRD): Cohort 1: TAK-041 5 mg n=6 Participants TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg n=6 Participants TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg n=6 Participants TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 3: TAK-041 80 mg TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 2 (MRD): Placebo Cohorts 1-4 TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the MRD period.	Part 2 (MRD): Cohort 1: TAK-041 40/20 mg TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 2: TAK-041 80/40 mg TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 3: TAK-041 120/60 mg TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 4: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.	Part 3: RBA/Food Effect: Regimen B TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part 4: MRD: Placebo TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia	Part 4: MRD: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.
Part 1: AUCt: Area Under the Plasma Concentration-Time Curve From Time 0 to Time t for TAK-041 in SRD Participants [Day 1]	44649.4 h*ng/mL Standard Deviation 5067.39	251124.1 h*ng/mL Standard Deviation 67210.68	18038.1 h*ng/mL Standard Deviation 9735.91	344075.1 h*ng/mL Standard Deviation 145462.41	361251.2 h*ng/mL Standard Deviation 97096.24	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Part 1: Pre-dose on Day 8 and at multiple timepoints (Up to 96 hours) post-dose

Population: PK Set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.

Outcome measures

Outcome measures
Measure	Part 3: RBA/Food Effect: Regimen B n=6 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part3:RBA/Food Effect:Regimen C-Part 1 Cohort2,Part 2 Cohort 1 Regimen C included participants from Part 1 Cohort 2 and Part 2 Cohort 1 who received TAK-041, 40 mg suspension, orally on Day 1 in fasted condition.	Part 1 (SRD): Cohort 1: TAK-041 5 mg n=6 Participants TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 3: TAK-041 80 mg TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 2 (MRD): Placebo Cohorts 1-4 TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the MRD period.	Part 2 (MRD): Cohort 1: TAK-041 40/20 mg TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 2: TAK-041 80/40 mg TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 3: TAK-041 120/60 mg TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 4: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.	Part 3: RBA/Food Effect: Regimen B TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part 4: MRD: Placebo TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia	Part 4: MRD: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.
Part 1: AUCt: Area Under the Plasma Concentration-Time Curve From Time 0 to Time t for TAK-041 in SRD Participants [Day 8], Cohorts 1 (20 mg) and 2 (40 mg) Only	202185.0 h*ng/mL Standard Deviation 38724.05	—	104692.7 h*ng/mL Standard Deviation 48397.26	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Parts 2 and 4: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose

Outcome measures

Outcome measures
Measure	Part 3: RBA/Food Effect: Regimen B n=6 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part3:RBA/Food Effect:Regimen C-Part 1 Cohort2,Part 2 Cohort 1 n=6 Participants Regimen C included participants from Part 1 Cohort 2 and Part 2 Cohort 1 who received TAK-041, 40 mg suspension, orally on Day 1 in fasted condition.	Part 1 (SRD): Cohort 1: TAK-041 5 mg n=6 Participants TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg n=6 Participants TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg n=15 Participants TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 3: TAK-041 80 mg TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 2 (MRD): Placebo Cohorts 1-4 TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the MRD period.	Part 2 (MRD): Cohort 1: TAK-041 40/20 mg TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 2: TAK-041 80/40 mg TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 3: TAK-041 120/60 mg TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 4: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.	Part 3: RBA/Food Effect: Regimen B TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part 4: MRD: Placebo TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia	Part 4: MRD: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.
Parts 2 and 4: AUCt: Area Under the Plasma Concentration-Time Curve From Time 0 to Time t for TAK-041 in MRD Participants [Day 1]	99401.9 h*ng/mL Standard Deviation 25287.60	147300.0 h*ng/mL Standard Deviation 16846.42	55530.5 h*ng/mL Standard Deviation 7016.30	203506.2 h*ng/mL Standard Deviation 49784.48	148889.0 h*ng/mL Standard Deviation 40389.92	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Part 3: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose

Outcome measures

Outcome measures
Measure	Part 3: RBA/Food Effect: Regimen B n=9 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part3:RBA/Food Effect:Regimen C-Part 1 Cohort2,Part 2 Cohort 1 n=12 Participants Regimen C included participants from Part 1 Cohort 2 and Part 2 Cohort 1 who received TAK-041, 40 mg suspension, orally on Day 1 in fasted condition.	Part 1 (SRD): Cohort 1: TAK-041 5 mg n=9 Participants TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 3: TAK-041 80 mg TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 2 (MRD): Placebo Cohorts 1-4 TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the MRD period.	Part 2 (MRD): Cohort 1: TAK-041 40/20 mg TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 2: TAK-041 80/40 mg TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 3: TAK-041 120/60 mg TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 4: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.	Part 3: RBA/Food Effect: Regimen B TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part 4: MRD: Placebo TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia	Part 4: MRD: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.
Part 3: AUCt: Area Under the Plasma Concentration-Time Curve From Time 0 to Time t for TAK-041 in RBA/Food Effect Participants [Day 1]	126001.0 h*ng/mL Standard Deviation 34652.19	128857.7 h*ng/mL Standard Deviation 81053.57	116064.6 h*ng/mL Standard Deviation 36590.93	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Part 1: Day 1 pre-dose and at multiple time points post dose, up to 96 hours for Cohorts 1 and 2; up to 168 hours for Cohorts 3-5

Population: PK Set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. For Part 1 (SRD): Cohorts 1 and 2: TAK-041 5 and 10 mg respectively data could not be analyzed as follow-up time was not enough to calculate AUC0-inf because of the long half-life of TAK-041.

Outcome measures

Outcome measures
Measure	Part 3: RBA/Food Effect: Regimen B TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part3:RBA/Food Effect:Regimen C-Part 1 Cohort2,Part 2 Cohort 1 n=6 Participants Regimen C included participants from Part 1 Cohort 2 and Part 2 Cohort 1 who received TAK-041, 40 mg suspension, orally on Day 1 in fasted condition.	Part 1 (SRD): Cohort 1: TAK-041 5 mg TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg n=6 Participants TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg n=6 Participants TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 3: TAK-041 80 mg TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 2 (MRD): Placebo Cohorts 1-4 TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the MRD period.	Part 2 (MRD): Cohort 1: TAK-041 40/20 mg TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 2: TAK-041 80/40 mg TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 3: TAK-041 120/60 mg TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 4: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.	Part 3: RBA/Food Effect: Regimen B TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part 4: MRD: Placebo TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia	Part 4: MRD: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.
Part 1: AUCinf: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-041 in SRD Participants [Day 1]	—	283461.1 h*ng/mL Standard Deviation 96704.07	—	381403.3 h*ng/mL Standard Deviation 208693.96	395932.4 h*ng/mL Standard Deviation 129676.19	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Part 1: Pre-dose on Day 8 and at multiple timepoints (Up to 96 hours) post-dose

Outcome measures

Outcome measures
Measure	Part 3: RBA/Food Effect: Regimen B n=6 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part3:RBA/Food Effect:Regimen C-Part 1 Cohort2,Part 2 Cohort 1 Regimen C included participants from Part 1 Cohort 2 and Part 2 Cohort 1 who received TAK-041, 40 mg suspension, orally on Day 1 in fasted condition.	Part 1 (SRD): Cohort 1: TAK-041 5 mg n=4 Participants TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 3: TAK-041 80 mg TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 2 (MRD): Placebo Cohorts 1-4 TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the MRD period.	Part 2 (MRD): Cohort 1: TAK-041 40/20 mg TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 2: TAK-041 80/40 mg TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 3: TAK-041 120/60 mg TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 4: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.	Part 3: RBA/Food Effect: Regimen B TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part 4: MRD: Placebo TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia	Part 4: MRD: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.
Part 1: AUCinf: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-041 in SRD Participants [Day 8], Cohorts 1 (20 mg) and 2 (40 mg) Only	203288.4 h*ng/mL Standard Deviation 39395.16	—	122801.1 h*ng/mL Standard Deviation 40764.68	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Parts 2 and 4: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose

Outcome measures

Outcome measures
Measure	Part 3: RBA/Food Effect: Regimen B n=6 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part3:RBA/Food Effect:Regimen C-Part 1 Cohort2,Part 2 Cohort 1 n=6 Participants Regimen C included participants from Part 1 Cohort 2 and Part 2 Cohort 1 who received TAK-041, 40 mg suspension, orally on Day 1 in fasted condition.	Part 1 (SRD): Cohort 1: TAK-041 5 mg n=6 Participants TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg n=6 Participants TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg n=15 Participants TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 3: TAK-041 80 mg TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 2 (MRD): Placebo Cohorts 1-4 TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the MRD period.	Part 2 (MRD): Cohort 1: TAK-041 40/20 mg TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 2: TAK-041 80/40 mg TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 3: TAK-041 120/60 mg TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 4: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.	Part 3: RBA/Food Effect: Regimen B TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part 4: MRD: Placebo TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia	Part 4: MRD: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.
Parts 2 and 4: AUCtau: Area Under the Plasma Concentration-Time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-041 in MRD Participants [Day 1]	99401.9 h*ng/mL Standard Deviation 25287.60	147300.0 h*ng/mL Standard Deviation 16846.42	55530.5 h*ng/mL Standard Deviation 7016.30	203506.2 h*ng/mL Standard Deviation 49784.48	148889.0 h*ng/mL Standard Deviation 40389.92	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Part 1: Day 1 pre-dose and at multiple time points post dose, up to 96 hours for Cohorts 1 and 2; up to 168 hours for Cohorts 3-5

Outcome measures

Outcome measures
Measure	Part 3: RBA/Food Effect: Regimen B TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part3:RBA/Food Effect:Regimen C-Part 1 Cohort2,Part 2 Cohort 1 n=6 Participants Regimen C included participants from Part 1 Cohort 2 and Part 2 Cohort 1 who received TAK-041, 40 mg suspension, orally on Day 1 in fasted condition.	Part 1 (SRD): Cohort 1: TAK-041 5 mg TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg n=6 Participants TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg n=6 Participants TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 3: TAK-041 80 mg TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 2 (MRD): Placebo Cohorts 1-4 TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the MRD period.	Part 2 (MRD): Cohort 1: TAK-041 40/20 mg TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 2: TAK-041 80/40 mg TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 3: TAK-041 120/60 mg TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 4: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.	Part 3: RBA/Food Effect: Regimen B TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part 4: MRD: Placebo TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia	Part 4: MRD: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.
Part 1: T1/2z: Terminal Disposition Phase Half-Life for TAK-041 in SRD Participants [Day 1]	—	284.0 hours Interval 107.0 to 431.0	—	208.0 hours Interval 55.0 to 450.0	260.6 hours Interval 108.0 to 402.0	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Part 1: Pre-dose on Day 8 and at multiple timepoints (Up to 96 hours) post-dose

Outcome measures

Outcome measures
Measure	Part 3: RBA/Food Effect: Regimen B n=6 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part3:RBA/Food Effect:Regimen C-Part 1 Cohort2,Part 2 Cohort 1 Regimen C included participants from Part 1 Cohort 2 and Part 2 Cohort 1 who received TAK-041, 40 mg suspension, orally on Day 1 in fasted condition.	Part 1 (SRD): Cohort 1: TAK-041 5 mg n=4 Participants TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 3: TAK-041 80 mg TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 2 (MRD): Placebo Cohorts 1-4 TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the MRD period.	Part 2 (MRD): Cohort 1: TAK-041 40/20 mg TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 2: TAK-041 80/40 mg TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 3: TAK-041 120/60 mg TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 4: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.	Part 3: RBA/Food Effect: Regimen B TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part 4: MRD: Placebo TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia	Part 4: MRD: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.
Part 1: T1/2z: Terminal Disposition Phase Half-Life for TAK-041 in SRD Participants [Day 8], Cohorts 1 (20 mg) and 2 (40 mg) Only	306.3 hours Interval 197.0 to 405.0	—	312.4 hours Interval 185.0 to 367.0	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Parts 2 and 4: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose

Outcome measures

Outcome measures
Measure	Part 3: RBA/Food Effect: Regimen B n=6 Participants TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part3:RBA/Food Effect:Regimen C-Part 1 Cohort2,Part 2 Cohort 1 n=6 Participants Regimen C included participants from Part 1 Cohort 2 and Part 2 Cohort 1 who received TAK-041, 40 mg suspension, orally on Day 1 in fasted condition.	Part 1 (SRD): Cohort 1: TAK-041 5 mg n=6 Participants TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg n=6 Participants TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg n=13 Participants TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 3: TAK-041 80 mg TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 2 (MRD): Placebo Cohorts 1-4 TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the MRD period.	Part 2 (MRD): Cohort 1: TAK-041 40/20 mg TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 2: TAK-041 80/40 mg TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 3: TAK-041 120/60 mg TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 4: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.	Part 3: RBA/Food Effect: Regimen B TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part 4: MRD: Placebo TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia	Part 4: MRD: TAK-041 160/80 mg TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.
Parts 2 and 4: T1/2z: Terminal Disposition Phase Half-Life for TAK-041 in MRD Participants [Day 1]	313.1 hours Interval 158.0 to 376.0	153.5 hours Interval 97.0 to 273.0	196.2 hours Interval 61.0 to 891.0	263.0 hours Interval 96.0 to 420.0	300.1 hours Interval 145.0 to 572.0	—	—	—	—	—	—	—	—	—	—	—	—

Deaths: 0 deaths

Part 4: MRD: Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Part 4: MRD: TAK-041 160/80 mg

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Part 1 (SRD): Placebo Cohorts 1-5 n=10 participants at risk TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 1: TAK-041 5 mg n=6 participants at risk TAK-041 5 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 2: TAK-041 10 mg n=6 participants at risk TAK-041 10 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 1: TAK-041 20 mg n=6 participants at risk TAK-041 20 mg, suspension, orally, once on Day 8 in the SRD period.	Part 1 (SRD): Cohort 2: TAK-041 40 mg n=6 participants at risk TAK-041 40 mg, suspension, orally, once on Day 8 in the SRD period.	Part 1 (SRD): Cohort 3: TAK-041 80 mg n=6 participants at risk TAK-041 80 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 4: TAK-041 120 mg n=6 participants at risk TAK-041 120 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 1 (SRD): Cohort 5: TAK-041 160 mg n=6 participants at risk；n=8 participants at risk TAK-041 160 mg, suspension, orally, once on Day 1 in fasted healthy participants in the SRD period.	Part 2 (MRD): Placebo Cohorts 1-4 n=8 participants at risk；n=6 participants at risk TAK-041 placebo-matching suspension, orally, once on Day 1 in fasted healthy participants in the MRD period.	Part 2 (MRD): Cohort 1: TAK-041 40/20 mg n=6 participants at risk TAK-041 40 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 20 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 2: TAK-041 80/40 mg n=6 participants at risk TAK-041 80 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 40 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 3: TAK-041 120/60 mg n=6 participants at risk TAK-041 120 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 60 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 2 (MRD): Cohort 4: TAK-041 160/80 mg n=6 participants at risk TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 in fasted healthy participants followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in the MRD period.	Part 3: Relative Bioavailability (RBA)/Food Effect: Regimen A n=9 participants at risk TAK-041 40 mg, tablet, orally, once on Day 1 in fasted state (Regimen A) in Cohort 1.	Part 3: RBA/Food Effect: Regimen B n=9 participants at risk TAK-041 40 mg, tablet, orally, once on Day 1 in fed state (Regimen B) in Cohort 2.	Part 4: MRD: Placebo n=8 participants at risk TAK-041 placebo-matching, suspension, orally, on Days 1, 8, 15 and 22 in participants with schizophrenia	Part 4: MRD: TAK-041 160/80 mg n=16 participants at risk TAK-041 160 mg as loading dose, suspension, orally, once on Day 1 followed by 80 mg (half the initial dose) as a maintenance dose on Days 8, 15 and 22 in participants with schizophrenia.
Gastrointestinal disorders Nausea	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 1/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 2/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Diarrhoea	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 1/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Limb fracture	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Headache	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.5% 1/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 3/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.5% 1/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.5% 2/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Dizziness	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Paraesthesia	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.5% 1/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Somnolence	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.5% 1/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 4/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Syncope	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 1/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Speech disorder	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Throat irritation	10.0% 1/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Cardiac disorders Palpitations	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Eye disorders Eyelid oedema	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.5% 1/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Toothache	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.5% 1/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Blood creatine phosphokinase increased	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.5% 1/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Application site irritation	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.5% 1/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Psychiatric disorders Agitation	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.5% 1/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.5% 1/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Psychiatric disorders Abnormal dreams	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 2/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.5% 2/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Psychiatric disorders Change in sustained attention	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.5% 1/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.5% 2/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Psychiatric disorders Euphoric mood	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.5% 1/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Rash	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Vascular disorders Orthostatic hypotension	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.5% 1/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Application site dermatitis	10.0% 1/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Catheter site phlebitis	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Fatigue	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Feeling abnormal	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.5% 1/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Energy increased	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.5% 1/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Upper respiratory tract infection	20.0% 2/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Gastroenteritis	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Conjunctivitis	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Contusion	0.00% 0/10 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 1/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 1/9 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • From the first dose of study drug up to 42 days after the last dose of study drug (Up to 12 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
Publication restrictions are in place

Restriction type: OTHER