Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Intranasal Esketamine in Treatment-resistant Depression (NCT NCT01998958)

NCT ID: NCT01998958

Last Updated: 2025-04-29

Results Overview

MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. A negative change in score indicates improvement.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

108 participants

Primary outcome timeframe

Baseline (Day 1) and Endpoint (Day 8) of Period 1

Results posted on

2025-04-29

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo (Panel A: Period 1) Participants self-administered placebo intranasally (1 spray to each nostril at 0, 5 and 10 minutes) on Days 1 and 4 of Period 1 in Panel A.	Esketamine 28 mg (Panel A: Period 1) Participants self administered esketamine 28 milligram (mg) intranasally (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 1 and 4 of Period 1 in Panel A.	Esketamine 56 mg (Panel A: Period 1) Participants self administered esketamine 56 mg intranasally (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 1 and 4 of Period 1 in Panel A.	Esketamine 84 mg (Panel A: Period 1) Participants self administered esketamine 84 mg intranasally (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) on Days 1 and 4 of Period 1 in Panel A.	Placebo (Panel B: Period 1) Participants self administered placebo intranasally (1 spray to each nostril at 0 and 5 minutes) on Days 1 and 4 of Period 1 in Panel B.	Esketamine 14 mg (Panel B: Period 1) Participants self administered esketamine 14 mg intranasally (1 spray of esketamine 14 mg into one nostril and 1 spray of placebo into other nostril at 0 minute and then 1 spray of placebo to each nostril at 5 minutes) on Days 1 and 4 of Period 1 in Panel B.	Esketamine 56 mg (Panel B: Period 1) Participants self administered esketamine 56 mg intranasally (1 spray of esketamine 14 mg into each nostril at 0 and 5 minutes) on Days 1 and 4 of Period 1 in Panel B.	Placebo (Panel A: Period 2) QIDS >= 11 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score greater than or equal to \[\>=\] 11) were re-randomized to receive Placebo (1 spray to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.	Placebo (Panel A: Period 2) QIDS<11 Participants Participants who were responders (with QIDS-SR16 score \<11) at the end of Period 1 in Panel A continued to receive placebo (1 spray to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.	Placebo to Esketamine 28mg (Panel A: Period 2) Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score \>=11) were re-randomized to receive esketamine 28 mg (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 8 and 11 of Period 2.	Placebo to Esketamine 56 mg (Panel A: Period 2) Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score \>=11) were re-randomized to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 of Period 2.	Placebo to Esketamine 84 mg (Panel A: Period 2) Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score \>=11) were re-randomized to receive esketamine 84 mg (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.	Esketamine 28 mg (Panel A: Period 2) Participants who received esketamine 28 mg in Period 1 of Panel A continued to receive esketamine 28 mg (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 8 and 11 of Period 2.	Esketamine 56 mg (Panel A: Period 2) Participants who received esketamine 56 mg in Period 1 of Panel A continued to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 of Period 2.	Esketamine 84 mg (Panel A: Period 2) Participants who received esketamine 84 mg in Period 1 of Panel A continued to receive esketamine 84 mg (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.	Placebo (Panel B: Period 2) QIDS >=11 Participants Participants who were non-responders with QIDS-SR16 score \>=11 at the end of Period 1 were re-randomized to receive placebo intranasally (1 spray of placebo into each nostril at 0 and 5 minutes using 4 separate devices) on Days 8 and 11 of Period 2 in Panel B.	Placebo (Panel B: Period 2) QIDS<11 Participants Participants who were responders with QIDS-SR16 score \<11 at the end of Period 1 continued to receive placebo intranasally (1 spray of placebo into each nostril at 0 and 5 minutes using 4 separate devices) on Days 8 and 11 in Period 2.	Placebo to Esketamine 14mg (Panel B: Period 2) Participants who received placebo in Period 1 and were non-responders with QIDS-SR16 score \>=11 at the end of Period 1 were re-randomized to receive esketamine 14 mg intranasally (1 spray of esketamine 14 mg into one nostril and 1 spray of placebo in other nostril at 0 minute and 1 spray of placebo in each nostril at 5 minutes using 4 separate devices) on Days 8 and 11 in Period 2.	Placebo to Esketamine 56mg (Panel B: Period 2) Participants who received placebo in Period 1 and were non-responders (with QIDS-SR16 score \>=11) at the end of Period 1 in Panel B were re-randomized to receive esketamine 56 mg intranasally (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 in Period 2.	Esketamine 14 mg (Panel B: Period 2) Participants who received esketamine 14 mg in Period 1 of Panel B continued to receive esketamine 14 mg (1 spray of esketamine 14 mg to one nostril and 1 spray of placebo into other nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 8 and 11 in Period 2.	Esketamine 56 mg (Panel B: Period 2) Participants who received esketamine 56 mg in Period 1 of Panel B continued to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 in Period 2.	Placebo/Placebo/Open Label Esketamine (Panel A) Participants who received Placebo in Period 1 and 2 of Panel A and elected to continue with open label phase received up to 9 single doses of intranasal esketamine on Days 15, 18, 22, 25, 32, 39, 46, 60 and 74. The doses for the optional open-label treatment phase included 28, 56, and 84 mg of esketamine. All participants started with intranasal esketamine 56 mg on Day 15. Subsequent doses on Days 18, 22, 25, 32, 39, and 46 could be adjusted to the next lower or higher dose, based on the investigator's clinical judgment. The same dose administered on Day 46 was administered on Day 60 and Day 74.	Placebo/Esketamine/Open Label Esketamine (Panel A) Participants who received Placebo in Period 1 and esketamine in Period 2 of Panel A and elected to continue with open label phase received up to 9 single doses of intranasal esketamine on Days 15, 18, 22, 25, 32, 39, 46, 60 and 74. The doses for the optional open-label treatment phase included 28, 56, and 84 mg of esketamine. All participants started with intranasal esketamine 56 mg on Day 15. Subsequent doses on Days 18, 22, 25, 32, 39, and 46 could be adjusted to the next lower or higher dose, based on the investigator's clinical judgment. The same dose administered on Day 46 was administered on Day 60 and Day 74.	Esketamine/Esketamine/Open Label Esketamine (Panel A) Participants who received esketamine in Period 1 and 2 of Panel A and elected to continue with open label phase received up to 9 single doses of intranasal esketamine on Days 15, 18, 22, 25, 32, 39, 46, 60 and 74. The doses for the optional open-label treatment phase included 28, 56, and 84 mg of esketamine. All participants started with intranasal esketamine 56 mg on Day 15. Subsequent doses on Days 18, 22, 25, 32, 39, and 46 could be adjusted to the next lower or higher dose, based on the investigator's clinical judgment. The same dose administered on Day 46 was administered on Day 60 and Day 74.	Placebo/Placebo/Open Label Esketamine (Panel B) Participants who received Placebo in Period 1 and 2 of Panel A and elected to continue with open label phase received up to 4 single doses of intranasal esketamine on Days 15, 18, 22 and 25. The doses for the optional open-label treatment phase included 14, 28 and 56 mg of esketamine. All participants started with intranasal esketamine 56 mg on Day 15. Subsequent doses on Days 18, 22 and 25 could be adjusted to the next lower or higher dose, based on the investigator's clinical judgment.	Placebo/Esketamine/Open Label Esketamine (Panel B) Participants who received Placebo in Period 1 and esketamine in Period 2 of Panel A and elected to continue with open label phase received up to 4 single doses of intranasal esketamine on Days 15, 18, 22 and 25. The doses for the optional open-label treatment phase included 14, 28 and 56 mg of esketamine. All participants started with intranasal esketamine 56 mg on Day 15. Subsequent doses on Days 18, 22 and 25 could be adjusted to the next lower or higher dose, based on the investigator's clinical judgment.	Esketamine/Esketamine/Open Label Esketamine (Panel B) Participants who received esketamine in Period 1 and 2 of Panel A and elected to continue with open label phase received up to 4 single doses of intranasal esketamine on Days 15, 18, 22 and 25. The doses for the optional open-label treatment phase included 14, 28 and 56 mg of esketamine. All participants started with intranasal esketamine 56 mg on Day 15. Subsequent doses on Days 18, 22 and 25 could be adjusted to the next lower or higher dose, based on the investigator's clinical judgment.	Placebo: Follow up Phase All participants whose last dose was Placebo in the double-blind phase or open label phase and were not consent withdrawn were followed for safety for 8 weeks.	Esketamine 14 mg: Follow up Phase All participants whose last dose was esketamine 14 mg in the double-blind phase or open label phase and were not consent withdrawn were followed for safety for 8 weeks.	Esketamine 28 mg: Follow up Phase All participants whose last dose was esketamine 28 mg in the double-blind phase or open label phase and were not consent withdrawn were followed for safety for 8 weeks.	Esketamine 56 mg: Follow up Phase All participants whose last dose was esketamine 56 mg in the double-blind phase or open label phase and were not consent withdrawn were followed for safety for 8 weeks.	Esketamine 84 mg: Follow up Phase All participants whose last dose was esketamine 84 mg in the double-blind phase or open label phase and were not consent withdrawn were followed for safety for 8 weeks.
Period 1 (Panel A and B) STARTED	33	11	11	12	21	11	9	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period 1 (Panel A and B) Rerandomized to Esketamine 56 mg	9	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period 1 (Panel A and B) Rerandomized to Esketamine 28mg	8	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period 1 (Panel A and B) Rerandomized to Esketamine 84mg	5	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period 1 (Panel A and B) COMPLETED	32	8	11	12	21	11	9	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period 1 (Panel A and B) NOT COMPLETED	1	3	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period 2 (Panel A and B) STARTED	0	0	0	0	0	0	0	6	4	8	9	5	8	11	12	5	8	5	3	11	9	0	0	0	0	0	0	0	0	0	0	0
Period 2 (Panel A and B) COMPLETED	0	0	0	0	0	0	0	6	4	8	8	5	8	11	10	5	8	5	2	11	9	0	0	0	0	0	0	0	0	0	0	0
Period 2 (Panel A and B) NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	1	0	0	0	2	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Open Label Phase (Optional) STARTED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	10	20	27	13	7	19	0	0	0	0	0
Open Label Phase (Optional) COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	7	11	23	13	7	19	0	0	0	0	0
Open Label Phase (Optional) NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	3	9	4	0	0	0	0	0	0	0	0
Follow-up Phase STARTED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	4	12	39	42
Follow-up Phase COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	4	12	39	42
Follow-up Phase NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo (Panel A: Period 1) Participants self-administered placebo intranasally (1 spray to each nostril at 0, 5 and 10 minutes) on Days 1 and 4 of Period 1 in Panel A.	Esketamine 28 mg (Panel A: Period 1) Participants self administered esketamine 28 milligram (mg) intranasally (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 1 and 4 of Period 1 in Panel A.	Placebo to Esketamine 56 mg (Panel A: Period 2) Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score \>=11) were re-randomized to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 of Period 2.	Esketamine 84 mg (Panel A: Period 2) Participants who received esketamine 84 mg in Period 1 of Panel A continued to receive esketamine 84 mg (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.	Placebo to Esketamine 56mg (Panel B: Period 2) Participants who received placebo in Period 1 and were non-responders (with QIDS-SR16 score \>=11) at the end of Period 1 in Panel B were re-randomized to receive esketamine 56 mg intranasally (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 in Period 2.	Placebo/Placebo/Open Label Esketamine (Panel A) Participants who received Placebo in Period 1 and 2 of Panel A and elected to continue with open label phase received up to 9 single doses of intranasal esketamine on Days 15, 18, 22, 25, 32, 39, 46, 60 and 74. The doses for the optional open-label treatment phase included 28, 56, and 84 mg of esketamine. All participants started with intranasal esketamine 56 mg on Day 15. Subsequent doses on Days 18, 22, 25, 32, 39, and 46 could be adjusted to the next lower or higher dose, based on the investigator's clinical judgment. The same dose administered on Day 46 was administered on Day 60 and Day 74.	Placebo/Esketamine/Open Label Esketamine (Panel A) Participants who received Placebo in Period 1 and esketamine in Period 2 of Panel A and elected to continue with open label phase received up to 9 single doses of intranasal esketamine on Days 15, 18, 22, 25, 32, 39, 46, 60 and 74. The doses for the optional open-label treatment phase included 28, 56, and 84 mg of esketamine. All participants started with intranasal esketamine 56 mg on Day 15. Subsequent doses on Days 18, 22, 25, 32, 39, and 46 could be adjusted to the next lower or higher dose, based on the investigator's clinical judgment. The same dose administered on Day 46 was administered on Day 60 and Day 74.	Esketamine/Esketamine/Open Label Esketamine (Panel A) Participants who received esketamine in Period 1 and 2 of Panel A and elected to continue with open label phase received up to 9 single doses of intranasal esketamine on Days 15, 18, 22, 25, 32, 39, 46, 60 and 74. The doses for the optional open-label treatment phase included 28, 56, and 84 mg of esketamine. All participants started with intranasal esketamine 56 mg on Day 15. Subsequent doses on Days 18, 22, 25, 32, 39, and 46 could be adjusted to the next lower or higher dose, based on the investigator's clinical judgment. The same dose administered on Day 46 was administered on Day 60 and Day 74.
Period 1 (Panel A and B) Withdrawal by Subject	0	1	0	0	0	0	0	0
Period 1 (Panel A and B) Lack of Efficacy	0	1	0	0	0	0	0	0
Period 1 (Panel A and B) Adverse Event	0	1	0	0	0	0	0	0
Period 1 (Panel A and B) Other	1	0	0	0	0	0	0	0
Period 2 (Panel A and B) Adverse Event	0	0	1	1	0	0	0	0
Period 2 (Panel A and B) Withdrawal by Subject	0	0	0	1	1	0	0	0
Open Label Phase (Optional) Adverse Event	0	0	0	0	0	0	0	1
Open Label Phase (Optional) Other	0	0	0	0	0	0	5	1
Open Label Phase (Optional) Lost to Follow-up	0	0	0	0	0	0	1	0
Open Label Phase (Optional) Lack of Efficacy	0	0	0	0	0	1	2	0
Open Label Phase (Optional) Withdrawal by Subject	0	0	0	0	0	2	1	2

Baseline Characteristics

A Study to Evaluate the Safety and Efficacy of Intranasal Esketamine in Treatment-resistant Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo (Panel A: Period 1) n=33 Participants Participants self-administered placebo intranasally (1 spray to each nostril at 0, 5 and 10 minutes) on Days 1 and 4 of Period 1 in Panel A.	Esketamine 28 mg (Panel A: Period 1) n=11 Participants Participants self administered esketamine 28 milligram (mg) intranasally (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 1 and 4 of Period 1 in Panel A.	Esketamine 56 mg (Panel A: Period 1) n=11 Participants Participants self administered esketamine 56 mg intranasally (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 1 and 4 of Period 1 in Panel A.	Esketamine 84 mg (Panel A: Period 1) n=12 Participants Participants self administered esketamine 84 mg intranasally (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) on Days 1 and 4 of Period 1 in Panel A.	Placebo (Panel B: Period 1) n=21 Participants Participants self administered placebo intranasally (1 spray to each nostril at 0 and 5 minutes) on Days 1 and 4 of Period 1 in Panel B.	Esketamine 14 mg (Panel B: Period 1) n=11 Participants Participants self administered esketamine 14 mg intranasally (1 spray of esketamine 14 mg into one nostril and 1 spray of placebo into other nostril at 0 minute and then 1 spray of placebo to each nostril at 5 minutes) on Days 1 and 4 of Period 1 in Panel B.	Esketamine 56 mg (Panel B: Period 1) n=9 Participants Participants self administered esketamine 56 mg intranasally (1 spray of esketamine 14 mg into each nostril at 0 and 5 minutes) on Days 1 and 4 of Period 1 in Panel B.	Total n=108 Participants Total of all reporting groups
Age, Continuous	44.4 years STANDARD_DEVIATION 9.60 • n=5 Participants	42.1 years STANDARD_DEVIATION 10.31 • n=7 Participants	42.7 years STANDARD_DEVIATION 11.23 • n=5 Participants	49.8 years STANDARD_DEVIATION 9.29 • n=4 Participants	45.3 years STANDARD_DEVIATION 7.66 • n=21 Participants	42.2 years STANDARD_DEVIATION 9.43 • n=10 Participants	45.6 years STANDARD_DEVIATION 7.35 • n=115 Participants	44.6 years STANDARD_DEVIATION 9.29 • n=6 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants	6 Participants n=4 Participants	9 Participants n=21 Participants	4 Participants n=10 Participants	4 Participants n=115 Participants	55 Participants n=6 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants	12 Participants n=21 Participants	7 Participants n=10 Participants	5 Participants n=115 Participants	53 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	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=10 Participants	0 Participants n=115 Participants	1 Participants n=6 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	21 Participants n=21 Participants	11 Participants n=10 Participants	9 Participants n=115 Participants	41 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	18 Participants n=6 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	11 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	48 Participants n=6 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) and Endpoint (Day 8) of Period 1

Population: Period 1 Intent-to-treat (ITT) analysis set included all participants randomly assigned to treatment in period 1.

Outcome measures

Outcome measures
Measure	Panel A: Period 2 Placebo n=33 Participants Participants who were non-responders at the end of Period 1 in Panel A (with Quick Inventory of Depressive Symptomatology - 16-item Self Report (QIDS-SR16) score \>=11) were randomly re-assigned to receive same Placebo (1 spray to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 28 mg n=11 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR 16 score \>=11) were randomly re-assigned to receive esketamine 28 mg (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 56 mg n=11 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score \>=11) were randomly re-assigned to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 84 mg n=12 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR 16 score \>=11) were randomly re-assigned to receive esketamine 84 mg (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel B: Period 2 Placebo n=21 Participants Participants who were non-responders with QIDS-SR 16 score \>=11 received placebo intranasally (1 spray of placebo into each nostril at 0 and 5 minutes) on Days 8 and 11 of Period 2.	Panel B: Period 2 Esketamine 14 mg n=11 Participants Participants who received placebo in Period 1 and were non-responders with QIDS-SR16 score \>=11 received esketamine 14 mg intranasally (1 spray of esketamine into one nostril and 1 spray of placebo in other nostril at 0 minutes and 1 spray of placebo in each nostril at 5 minutes) in Period 2.	Panel B: Period 2 Esketamine 56 mg n=9 Participants Participants who were responders (with QIDS-SR16 score \<11) at the end of Period 1 in Panel B continued to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 in Period 2.
Panel A and B: Change From Baseline (Day 1) in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Day 8- Analysis of Covariance (ANCOVA) Analysis	-4.9 Unit on a scale Standard Error 1.74	-9.8 Unit on a scale Standard Error 2.72	-12.4 Unit on a scale Standard Error 2.66	-15.3 Unit on a scale Standard Error 2.56	-6.6 Unit on a scale Standard Error 1.53	-4.8 Unit on a scale Standard Error 2.13	-10.3 Unit on a scale Standard Error 2.36

PRIMARY outcome

Timeframe: Baseline (Day 8) and Endpoint (Day 15) of Period 2

Population: Period 2 ITT analysis set included non-responders (QIDS-SR16 total score \>=11) to placebo treatment in Period 1 and were then randomly re-assigned to a treatment group in Period 2. Only placebo participants with a QIDS-SR16 score \>= 11 at End Point Period 1 who were re-randomized in Period 2 are included in the Period 2 summary.

Outcome measures

Outcome measures
Measure	Panel A: Period 2 Placebo n=6 Participants Participants who were non-responders at the end of Period 1 in Panel A (with Quick Inventory of Depressive Symptomatology - 16-item Self Report (QIDS-SR16) score \>=11) were randomly re-assigned to receive same Placebo (1 spray to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 28 mg n=8 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR 16 score \>=11) were randomly re-assigned to receive esketamine 28 mg (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 56 mg n=9 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score \>=11) were randomly re-assigned to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 84 mg n=5 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR 16 score \>=11) were randomly re-assigned to receive esketamine 84 mg (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel B: Period 2 Placebo n=5 Participants Participants who were non-responders with QIDS-SR 16 score \>=11 received placebo intranasally (1 spray of placebo into each nostril at 0 and 5 minutes) on Days 8 and 11 of Period 2.	Panel B: Period 2 Esketamine 14 mg n=5 Participants Participants who received placebo in Period 1 and were non-responders with QIDS-SR16 score \>=11 received esketamine 14 mg intranasally (1 spray of esketamine into one nostril and 1 spray of placebo in other nostril at 0 minutes and 1 spray of placebo in each nostril at 5 minutes) in Period 2.	Panel B: Period 2 Esketamine 56 mg n=3 Participants Participants who were responders (with QIDS-SR16 score \<11) at the end of Period 1 in Panel B continued to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 in Period 2.
Panel A and B: Change From Baseline (Day 8) in Montgomery Asberg Depression Rating Scale Total Score at Day 15- ANCOVA Analysis	-4.5 Unit on a scale Standard Error 2.92	-7.6 Unit on a scale Standard Error 2.49	-8.9 Unit on a scale Standard Error 2.51	-11.4 Unit on a scale Standard Error 2.68	-0.7 Unit on a scale Standard Error 3.32	-6.6 Unit on a scale Standard Error 4.02	-1.2 Unit on a scale Standard Error 6.04

SECONDARY outcome

Timeframe: Day 2 Up to Day 15

Population: Population analyzed included participants from double-blind (DB) ITT (who were randomly assigned to treatment during the double-blind phase) who completed the double-blind phase and received the same treatment for both periods.

Sustained response was defined as at least 50% improvement from baseline in the MADRS total score with onset by Day 2 that is maintained to study Day 15. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition.

Outcome measures

Outcome measures
Measure	Panel A: Period 2 Placebo n=10 Participants Participants who were non-responders at the end of Period 1 in Panel A (with Quick Inventory of Depressive Symptomatology - 16-item Self Report (QIDS-SR16) score \>=11) were randomly re-assigned to receive same Placebo (1 spray to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 28 mg n=8 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR 16 score \>=11) were randomly re-assigned to receive esketamine 28 mg (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 56 mg n=11 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score \>=11) were randomly re-assigned to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 84 mg n=10 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR 16 score \>=11) were randomly re-assigned to receive esketamine 84 mg (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel B: Period 2 Placebo n=13 Participants Participants who were non-responders with QIDS-SR 16 score \>=11 received placebo intranasally (1 spray of placebo into each nostril at 0 and 5 minutes) on Days 8 and 11 of Period 2.	Panel B: Period 2 Esketamine 14 mg n=11 Participants Participants who received placebo in Period 1 and were non-responders with QIDS-SR16 score \>=11 received esketamine 14 mg intranasally (1 spray of esketamine into one nostril and 1 spray of placebo in other nostril at 0 minutes and 1 spray of placebo in each nostril at 5 minutes) in Period 2.	Panel B: Period 2 Esketamine 56 mg n=9 Participants Participants who were responders (with QIDS-SR16 score \<11) at the end of Period 1 in Panel B continued to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 in Period 2.
Panel A and B: Percentage of Participants With Sustained Response Based on MADRS Total Score in Participants Who Have Completed the Double-Blind Phase and Received the Same Treatment for Both Periods	0 Percentage of participants	12.5 Percentage of participants	9.1 Percentage of participants	30.0 Percentage of participants	15.4 Percentage of participants	18.2 Percentage of participants	22.2 Percentage of participants

SECONDARY outcome

Timeframe: Day 2 Up to Day 15

Population: Population analyzed included participants from DB ITT (who were randomly assigned to treatment during the double-blind phase) who received the same treatment for both periods, including participants who did not complete the double-blind Phase.

Sustained response was defined as at least 50 percent (%) improvement from baseline in the MADRS total score with onset by Day 2 that is maintained to study Day 15. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition.

Outcome measures

Outcome measures
Measure	Panel A: Period 2 Placebo n=10 Participants Participants who were non-responders at the end of Period 1 in Panel A (with Quick Inventory of Depressive Symptomatology - 16-item Self Report (QIDS-SR16) score \>=11) were randomly re-assigned to receive same Placebo (1 spray to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 28 mg n=8 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR 16 score \>=11) were randomly re-assigned to receive esketamine 28 mg (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 56 mg n=11 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score \>=11) were randomly re-assigned to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 84 mg n=12 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR 16 score \>=11) were randomly re-assigned to receive esketamine 84 mg (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel B: Period 2 Placebo n=13 Participants Participants who were non-responders with QIDS-SR 16 score \>=11 received placebo intranasally (1 spray of placebo into each nostril at 0 and 5 minutes) on Days 8 and 11 of Period 2.	Panel B: Period 2 Esketamine 14 mg n=11 Participants Participants who received placebo in Period 1 and were non-responders with QIDS-SR16 score \>=11 received esketamine 14 mg intranasally (1 spray of esketamine into one nostril and 1 spray of placebo in other nostril at 0 minutes and 1 spray of placebo in each nostril at 5 minutes) in Period 2.	Panel B: Period 2 Esketamine 56 mg n=9 Participants Participants who were responders (with QIDS-SR16 score \<11) at the end of Period 1 in Panel B continued to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 in Period 2.
Panel A and B: Percentage of Participants With Sustained Response Based on MADRS Total Score in Participants Who Received the Same Treatment for Both Periods, Including Participants Who Did Not Complete the Double-blind Phase	0 Percentage of participants	12.5 Percentage of participants	9.1 Percentage of participants	25.0 Percentage of participants	15.4 Percentage of participants	18.2 Percentage of participants	22.2 Percentage of participants

SECONDARY outcome

Timeframe: Period 1: Days 1 (2 hour), 2 and 8 of Double-blind Phase

Population: Period 1 ITT analysis set included all participants randomly assigned to treatment in period 1.

A participant is defined a responder at a given time point if the percent improvement in MADRS is greater than or equal to (\>=) 50%. Participant who do not meet such criterion, worsen or discontinue during the DB phase for any reason was considered as non-responders, that is, was assigned a value of 0. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition.

Outcome measures

Outcome measures
Measure	Panel A: Period 2 Placebo n=33 Participants Participants who were non-responders at the end of Period 1 in Panel A (with Quick Inventory of Depressive Symptomatology - 16-item Self Report (QIDS-SR16) score \>=11) were randomly re-assigned to receive same Placebo (1 spray to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 28 mg n=11 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR 16 score \>=11) were randomly re-assigned to receive esketamine 28 mg (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 56 mg n=11 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score \>=11) were randomly re-assigned to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 84 mg n=12 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR 16 score \>=11) were randomly re-assigned to receive esketamine 84 mg (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel B: Period 2 Placebo n=21 Participants Participants who were non-responders with QIDS-SR 16 score \>=11 received placebo intranasally (1 spray of placebo into each nostril at 0 and 5 minutes) on Days 8 and 11 of Period 2.	Panel B: Period 2 Esketamine 14 mg n=11 Participants Participants who received placebo in Period 1 and were non-responders with QIDS-SR16 score \>=11 received esketamine 14 mg intranasally (1 spray of esketamine into one nostril and 1 spray of placebo in other nostril at 0 minutes and 1 spray of placebo in each nostril at 5 minutes) in Period 2.	Panel B: Period 2 Esketamine 56 mg n=9 Participants Participants who were responders (with QIDS-SR16 score \<11) at the end of Period 1 in Panel B continued to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 in Period 2.
Panel A and B: Percentage of Participants With Response Based on MADRS Total Score Day 1 (2 hour)	18.2 Percentage of participants	54.5 Percentage of participants	36.4 Percentage of participants	58.3 Percentage of participants	33.3 Percentage of participants	36.4 Percentage of participants	44.4 Percentage of participants
Panel A and B: Percentage of Participants With Response Based on MADRS Total Score Day 2	3.0 Percentage of participants	36.4 Percentage of participants	27.3 Percentage of participants	41.7 Percentage of participants	28.6 Percentage of participants	36.4 Percentage of participants	44.4 Percentage of participants
Panel A and B: Percentage of Participants With Response Based on MADRS Total Score Day 8	6.1 Percentage of participants	9.1 Percentage of participants	18.2 Percentage of participants	41.7 Percentage of participants	23.8 Percentage of participants	18.2 Percentage of participants	22.2 Percentage of participants

SECONDARY outcome

Timeframe: Period 2: Days 1 (2 hour), 2 and 8 of Double-blind Phase

A participant is defined a responder at a given time point if the percent improvement in MADRS is \>=50%. Participant who do not meet such criterion, worsen or discontinue during the DB phase for any reason was considered as non-responders, that is, was assigned a value of 0. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition.

Outcome measures

Outcome measures
Measure	Panel A: Period 2 Placebo n=6 Participants Participants who were non-responders at the end of Period 1 in Panel A (with Quick Inventory of Depressive Symptomatology - 16-item Self Report (QIDS-SR16) score \>=11) were randomly re-assigned to receive same Placebo (1 spray to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 28 mg n=8 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR 16 score \>=11) were randomly re-assigned to receive esketamine 28 mg (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 56 mg n=9 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score \>=11) were randomly re-assigned to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 84 mg n=5 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR 16 score \>=11) were randomly re-assigned to receive esketamine 84 mg (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel B: Period 2 Placebo n=5 Participants Participants who were non-responders with QIDS-SR 16 score \>=11 received placebo intranasally (1 spray of placebo into each nostril at 0 and 5 minutes) on Days 8 and 11 of Period 2.	Panel B: Period 2 Esketamine 14 mg n=5 Participants Participants who received placebo in Period 1 and were non-responders with QIDS-SR16 score \>=11 received esketamine 14 mg intranasally (1 spray of esketamine into one nostril and 1 spray of placebo in other nostril at 0 minutes and 1 spray of placebo in each nostril at 5 minutes) in Period 2.	Panel B: Period 2 Esketamine 56 mg n=3 Participants Participants who were responders (with QIDS-SR16 score \<11) at the end of Period 1 in Panel B continued to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 in Period 2.
Panel A and B: Percentage of Participants With Response Based on MADRS Total Score Day 1 (2 hour)	16.7 Percentage of participants	12.5 Percentage of participants	22.2 Percentage of participants	40.0 Percentage of participants	0 Percentage of participants	60.0 Percentage of participants	0 Percentage of participants
Panel A and B: Percentage of Participants With Response Based on MADRS Total Score Day 2	0 Percentage of participants	0 Percentage of participants	11.1 Percentage of participants	40.0 Percentage of participants	0 Percentage of participants	80.0 Percentage of participants	0 Percentage of participants
Panel A and B: Percentage of Participants With Response Based on MADRS Total Score Day 8	0 Percentage of participants	12.5 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

SECONDARY outcome

Timeframe: Days 1, 2 and 8 of Double-blind Phase of Period 1

Population: Period 1 ITT analysis set included all participants randomly assigned to treatment in period 1.

Participants who had a MADRS total score of \<=10 were considered remitters. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition.

Outcome measures

Outcome measures
Measure	Panel A: Period 2 Placebo n=33 Participants Participants who were non-responders at the end of Period 1 in Panel A (with Quick Inventory of Depressive Symptomatology - 16-item Self Report (QIDS-SR16) score \>=11) were randomly re-assigned to receive same Placebo (1 spray to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 28 mg n=11 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR 16 score \>=11) were randomly re-assigned to receive esketamine 28 mg (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 56 mg n=11 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score \>=11) were randomly re-assigned to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 84 mg n=12 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR 16 score \>=11) were randomly re-assigned to receive esketamine 84 mg (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel B: Period 2 Placebo n=21 Participants Participants who were non-responders with QIDS-SR 16 score \>=11 received placebo intranasally (1 spray of placebo into each nostril at 0 and 5 minutes) on Days 8 and 11 of Period 2.	Panel B: Period 2 Esketamine 14 mg n=11 Participants Participants who received placebo in Period 1 and were non-responders with QIDS-SR16 score \>=11 received esketamine 14 mg intranasally (1 spray of esketamine into one nostril and 1 spray of placebo in other nostril at 0 minutes and 1 spray of placebo in each nostril at 5 minutes) in Period 2.	Panel B: Period 2 Esketamine 56 mg n=9 Participants Participants who were responders (with QIDS-SR16 score \<11) at the end of Period 1 in Panel B continued to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 in Period 2.
Panel A and B: Percentage of Participants in Remission Based on MADRS Total Score at Days 1, 2 and 8 of Double-blind Phase Day 1	3.0 Percentage of participants	27.3 Percentage of participants	18.2 Percentage of participants	25.0 Percentage of participants	19.0 Percentage of participants	36.4 Percentage of participants	33.3 Percentage of participants
Panel A and B: Percentage of Participants in Remission Based on MADRS Total Score at Days 1, 2 and 8 of Double-blind Phase Day 2	0 Percentage of participants	36.4 Percentage of participants	18.2 Percentage of participants	25.0 Percentage of participants	19.0 Percentage of participants	27.3 Percentage of participants	33.3 Percentage of participants
Panel A and B: Percentage of Participants in Remission Based on MADRS Total Score at Days 1, 2 and 8 of Double-blind Phase Day 8	3.0 Percentage of participants	9.1 Percentage of participants	9.1 Percentage of participants	25.0 Percentage of participants	14.3 Percentage of participants	18.2 Percentage of participants	22.2 Percentage of participants

SECONDARY outcome

Timeframe: Days 1, 2 and 8 of Double-blind Phase of Period 2

Participants who had a MADRS total score of less than or equal to (\<=10) were considered remitters. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. A negative change in score indicates improvement.

Outcome measures

Outcome measures
Measure	Panel A: Period 2 Placebo n=6 Participants Participants who were non-responders at the end of Period 1 in Panel A (with Quick Inventory of Depressive Symptomatology - 16-item Self Report (QIDS-SR16) score \>=11) were randomly re-assigned to receive same Placebo (1 spray to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 28 mg n=8 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR 16 score \>=11) were randomly re-assigned to receive esketamine 28 mg (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 56 mg n=9 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score \>=11) were randomly re-assigned to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 84 mg n=5 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR 16 score \>=11) were randomly re-assigned to receive esketamine 84 mg (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel B: Period 2 Placebo n=5 Participants Participants who were non-responders with QIDS-SR 16 score \>=11 received placebo intranasally (1 spray of placebo into each nostril at 0 and 5 minutes) on Days 8 and 11 of Period 2.	Panel B: Period 2 Esketamine 14 mg n=5 Participants Participants who received placebo in Period 1 and were non-responders with QIDS-SR16 score \>=11 received esketamine 14 mg intranasally (1 spray of esketamine into one nostril and 1 spray of placebo in other nostril at 0 minutes and 1 spray of placebo in each nostril at 5 minutes) in Period 2.	Panel B: Period 2 Esketamine 56 mg n=3 Participants Participants who were responders (with QIDS-SR16 score \<11) at the end of Period 1 in Panel B continued to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 in Period 2.
Panel A and B: Percentage of Participants in Remission Based on MADRS Total Score at Days 1, 2 and 8 of Double-blind Phase Day 1	16.7 Percentage of participants	12.5 Percentage of participants	0 Percentage of participants	40.0 Percentage of participants	0 Percentage of participants	60.0 Percentage of participants	0 Percentage of participants
Panel A and B: Percentage of Participants in Remission Based on MADRS Total Score at Days 1, 2 and 8 of Double-blind Phase Day 2	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	20.0 Percentage of participants	0 Percentage of participants	80.0 Percentage of participants	0 Percentage of participants
Panel A and B: Percentage of Participants in Remission Based on MADRS Total Score at Days 1, 2 and 8 of Double-blind Phase Day 8	0 Percentage of participants	12.5 Percentage of participants	0 Percentage of participants	20.0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Endpoint (Day 8) of Period 1

Population: Period 1 ITT analysis set included all participants randomly assigned to treatment in period 1.

QIDS-SR16 is self-rated scale assesses severity of depressive symptoms. Total scores range from 0-27. Higher score indicates greater severity of depression. Negative change in score indicates improvement. Total score obtained by adding scores for each of 9 symptom domains of Diagnostic and Statistical Manual of Mental Disorders-4th edition major depressive disorder (DSM-IV MDD) criteria: depressed mood, loss of interest/pleasure, concentration/decision making, self-outlook, suicidal ideation, energy/fatigability, sleep, weight/appetite change, psychomotor changes. 16 items used to rate 9 criterion domains: 4 items used to rate sleep disturbance (early/middle/late insomnia/hypersomnia); 2 items used to rate psychomotor disturbance (agitation, retardation); 4 items used to rate appetite/weight disturbance. 1 item used to rate 6 domains (depressed mood, decreased interest, decreased energy, worthlessness/guilt, concentration/decision making, suicidal ideation). Each item was rated 0-3.

Outcome measures

Outcome measures
Measure	Panel A: Period 2 Placebo n=33 Participants Participants who were non-responders at the end of Period 1 in Panel A (with Quick Inventory of Depressive Symptomatology - 16-item Self Report (QIDS-SR16) score \>=11) were randomly re-assigned to receive same Placebo (1 spray to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 28 mg n=11 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR 16 score \>=11) were randomly re-assigned to receive esketamine 28 mg (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 56 mg n=11 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score \>=11) were randomly re-assigned to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 84 mg n=12 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR 16 score \>=11) were randomly re-assigned to receive esketamine 84 mg (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel B: Period 2 Placebo n=21 Participants Participants who were non-responders with QIDS-SR 16 score \>=11 received placebo intranasally (1 spray of placebo into each nostril at 0 and 5 minutes) on Days 8 and 11 of Period 2.	Panel B: Period 2 Esketamine 14 mg n=11 Participants Participants who received placebo in Period 1 and were non-responders with QIDS-SR16 score \>=11 received esketamine 14 mg intranasally (1 spray of esketamine into one nostril and 1 spray of placebo in other nostril at 0 minutes and 1 spray of placebo in each nostril at 5 minutes) in Period 2.	Panel B: Period 2 Esketamine 56 mg n=9 Participants Participants who were responders (with QIDS-SR16 score \<11) at the end of Period 1 in Panel B continued to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 in Period 2.
Panel A and B: Change From Baseline (Day 1) in Quick Inventory of Depressive Symptomatology-16-item Self Report (QIDS-SR16) Total Score at Day 8 in the Double-Blind Treatment Phase- ANCOVA Analysis	-1.8 Unit on a scale Standard Error 0.93	-4.0 Unit on a scale Standard Error 1.43	-4.4 Unit on a scale Standard Error 1.43	-4.2 Unit on a scale Standard Error 1.39	-1.1 Unit on a scale Standard Error 0.78	-0.6 Unit on a scale Standard Error 1.10	-3.0 Unit on a scale Standard Error 1.20

SECONDARY outcome

Timeframe: Baseline (Day 8) and Endpoint (Day 15) of Period 2

Outcome measures

Outcome measures
Measure	Panel A: Period 2 Placebo n=6 Participants Participants who were non-responders at the end of Period 1 in Panel A (with Quick Inventory of Depressive Symptomatology - 16-item Self Report (QIDS-SR16) score \>=11) were randomly re-assigned to receive same Placebo (1 spray to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 28 mg n=8 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR 16 score \>=11) were randomly re-assigned to receive esketamine 28 mg (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 56 mg n=9 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score \>=11) were randomly re-assigned to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 84 mg n=5 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR 16 score \>=11) were randomly re-assigned to receive esketamine 84 mg (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel B: Period 2 Placebo n=5 Participants Participants who were non-responders with QIDS-SR 16 score \>=11 received placebo intranasally (1 spray of placebo into each nostril at 0 and 5 minutes) on Days 8 and 11 of Period 2.	Panel B: Period 2 Esketamine 14 mg n=5 Participants Participants who received placebo in Period 1 and were non-responders with QIDS-SR16 score \>=11 received esketamine 14 mg intranasally (1 spray of esketamine into one nostril and 1 spray of placebo in other nostril at 0 minutes and 1 spray of placebo in each nostril at 5 minutes) in Period 2.	Panel B: Period 2 Esketamine 56 mg n=3 Participants Participants who were responders (with QIDS-SR16 score \<11) at the end of Period 1 in Panel B continued to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 in Period 2.
Panel A and B: Change From Baseline (Day 8) in Quick Inventory of Depressive Symptomatology-16-item Self Report Total Score at Day 15 in the Double-Blind Treatment Phase- ANCOVA Analysis	-2.0 Unit on a scale Standard Error 1.50	-3.1 Unit on a scale Standard Error 1.35	-2.0 Unit on a scale Standard Error 1.41	-3.3 Unit on a scale Standard Error 1.48	-2.1 Unit on a scale Standard Error 1.78	-5.7 Unit on a scale Standard Error 1.78	-1.5 Unit on a scale Standard Error 2.31

SECONDARY outcome

Timeframe: Baseline (Day 1) and Endpoint (Day 8) of Period 1

Population: Period 1 ITT analysis set included all participants randomly assigned to treatment in period 1.

CGI-S provides measure of severity of participant's illness including participant's history, psychosocial circumstances, symptoms, behavior and impact of symptoms on ability to function. CGI-S evaluates severity of psychopathology on scale of 0 to 7. Considering total clinical experience, participant is assessed on severity of mental illness according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among most extremely ill patients. CGI-S permits global evaluation of participant's condition at given time. A negative change in score indicates improvement.

Outcome measures

Outcome measures
Measure	Panel A: Period 2 Placebo n=33 Participants Participants who were non-responders at the end of Period 1 in Panel A (with Quick Inventory of Depressive Symptomatology - 16-item Self Report (QIDS-SR16) score \>=11) were randomly re-assigned to receive same Placebo (1 spray to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 28 mg n=11 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR 16 score \>=11) were randomly re-assigned to receive esketamine 28 mg (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 56 mg n=11 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score \>=11) were randomly re-assigned to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 84 mg n=12 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR 16 score \>=11) were randomly re-assigned to receive esketamine 84 mg (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel B: Period 2 Placebo n=21 Participants Participants who were non-responders with QIDS-SR 16 score \>=11 received placebo intranasally (1 spray of placebo into each nostril at 0 and 5 minutes) on Days 8 and 11 of Period 2.	Panel B: Period 2 Esketamine 14 mg n=11 Participants Participants who received placebo in Period 1 and were non-responders with QIDS-SR16 score \>=11 received esketamine 14 mg intranasally (1 spray of esketamine into one nostril and 1 spray of placebo in other nostril at 0 minutes and 1 spray of placebo in each nostril at 5 minutes) in Period 2.	Panel B: Period 2 Esketamine 56 mg n=9 Participants Participants who were responders (with QIDS-SR16 score \<11) at the end of Period 1 in Panel B continued to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 in Period 2.
Panel A and B: Change From Baseline (Day 1) in Clinical Global Impression - Severity (CGI-S) Total Score at Day 8 in the Double-Blind Treatment Phase- ANCOVA Analysis on Ranks	5.0 Units on a scale Interval 1.0 to 6.0	4.0 Units on a scale Interval 3.0 to 5.0	4.0 Units on a scale Interval 1.0 to 5.0	4.0 Units on a scale Interval 1.0 to 6.0	4.0 Units on a scale Interval 1.0 to 6.0	4.0 Units on a scale Interval 2.0 to 6.0	3.0 Units on a scale Interval 3.0 to 6.0

SECONDARY outcome

Timeframe: Baseline (Day 8) and Endpoint (Day 15) of Period 2

Outcome measures

Outcome measures
Measure	Panel A: Period 2 Placebo n=6 Participants Participants who were non-responders at the end of Period 1 in Panel A (with Quick Inventory of Depressive Symptomatology - 16-item Self Report (QIDS-SR16) score \>=11) were randomly re-assigned to receive same Placebo (1 spray to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 28 mg n=8 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR 16 score \>=11) were randomly re-assigned to receive esketamine 28 mg (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 56 mg n=9 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score \>=11) were randomly re-assigned to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 84 mg n=5 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR 16 score \>=11) were randomly re-assigned to receive esketamine 84 mg (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel B: Period 2 Placebo n=5 Participants Participants who were non-responders with QIDS-SR 16 score \>=11 received placebo intranasally (1 spray of placebo into each nostril at 0 and 5 minutes) on Days 8 and 11 of Period 2.	Panel B: Period 2 Esketamine 14 mg n=5 Participants Participants who received placebo in Period 1 and were non-responders with QIDS-SR16 score \>=11 received esketamine 14 mg intranasally (1 spray of esketamine into one nostril and 1 spray of placebo in other nostril at 0 minutes and 1 spray of placebo in each nostril at 5 minutes) in Period 2.	Panel B: Period 2 Esketamine 56 mg n=3 Participants Participants who were responders (with QIDS-SR16 score \<11) at the end of Period 1 in Panel B continued to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 in Period 2.
Panel A and B: Change From Baseline (Day 8) in Clinical Global Impression - Severity Total Score at Day 15 in the Double-Blind Treatment Phase- ANCOVA Analysis on Ranks	5.0 Units on a scale Interval 4.0 to 5.0	4.0 Units on a scale Interval 3.0 to 5.0	5.0 Units on a scale Interval 4.0 to 6.0	4.0 Units on a scale Interval 3.0 to 5.0	4.0 Units on a scale Interval 3.0 to 6.0	3.0 Units on a scale Interval 3.0 to 4.0	4.0 Units on a scale Interval 4.0 to 5.0

SECONDARY outcome

Timeframe: Baseline (Day 1) and Endpoint (Day 8) of Period 1

Population: Period 1 ITT analysis set included all participants randomly assigned to treatment in period 1.

GAD-7 is a brief and validated 7-item self-report assessment of overall anxiety. Participants respond to each item using a 4-point scale with response categories of 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield a total score with a range of 0 to 21, where higher scores indicate more anxiety. The recall period is 2 weeks. The severity of the GAD-7 is categorized as follows: None (0-4), Mild (5-9), Moderate (10-14) and Severe (15 -21).

Outcome measures

Outcome measures
Measure	Panel A: Period 2 Placebo n=33 Participants Participants who were non-responders at the end of Period 1 in Panel A (with Quick Inventory of Depressive Symptomatology - 16-item Self Report (QIDS-SR16) score \>=11) were randomly re-assigned to receive same Placebo (1 spray to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 28 mg n=11 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR 16 score \>=11) were randomly re-assigned to receive esketamine 28 mg (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 56 mg n=11 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score \>=11) were randomly re-assigned to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 84 mg n=12 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR 16 score \>=11) were randomly re-assigned to receive esketamine 84 mg (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel B: Period 2 Placebo n=21 Participants Participants who were non-responders with QIDS-SR 16 score \>=11 received placebo intranasally (1 spray of placebo into each nostril at 0 and 5 minutes) on Days 8 and 11 of Period 2.	Panel B: Period 2 Esketamine 14 mg n=11 Participants Participants who received placebo in Period 1 and were non-responders with QIDS-SR16 score \>=11 received esketamine 14 mg intranasally (1 spray of esketamine into one nostril and 1 spray of placebo in other nostril at 0 minutes and 1 spray of placebo in each nostril at 5 minutes) in Period 2.	Panel B: Period 2 Esketamine 56 mg n=9 Participants Participants who were responders (with QIDS-SR16 score \<11) at the end of Period 1 in Panel B continued to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 in Period 2.
Panel A and B: Change From Baseline (Day 1) in Generalized Anxiety Disorder (GAD-7) Total Score at Day 8 (Double-Blind Treatment Phase) ANCOVA Analysis	-1.7 Unit on a scale Standard Error 0.88	-1.5 Unit on a scale Standard Error 1.34	-3.1 Unit on a scale Standard Error 1.34	-5.1 Unit on a scale Standard Error 1.30	-1.7 Unit on a scale Standard Error 0.68	-1.9 Unit on a scale Standard Error 0.94	-3.2 Unit on a scale Standard Error 1.03

SECONDARY outcome

Timeframe: Baseline (Day 8) and Endpoint (Day 15) of Period 2

Outcome measures

Outcome measures
Measure	Panel A: Period 2 Placebo n=6 Participants Participants who were non-responders at the end of Period 1 in Panel A (with Quick Inventory of Depressive Symptomatology - 16-item Self Report (QIDS-SR16) score \>=11) were randomly re-assigned to receive same Placebo (1 spray to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 28 mg n=8 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR 16 score \>=11) were randomly re-assigned to receive esketamine 28 mg (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 56 mg n=9 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score \>=11) were randomly re-assigned to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 84 mg n=5 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR 16 score \>=11) were randomly re-assigned to receive esketamine 84 mg (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel B: Period 2 Placebo n=5 Participants Participants who were non-responders with QIDS-SR 16 score \>=11 received placebo intranasally (1 spray of placebo into each nostril at 0 and 5 minutes) on Days 8 and 11 of Period 2.	Panel B: Period 2 Esketamine 14 mg n=5 Participants Participants who received placebo in Period 1 and were non-responders with QIDS-SR16 score \>=11 received esketamine 14 mg intranasally (1 spray of esketamine into one nostril and 1 spray of placebo in other nostril at 0 minutes and 1 spray of placebo in each nostril at 5 minutes) in Period 2.	Panel B: Period 2 Esketamine 56 mg n=3 Participants Participants who were responders (with QIDS-SR16 score \<11) at the end of Period 1 in Panel B continued to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 in Period 2.
Panel A and B: Change From Baseline (Day 8) in Generalized Anxiety Disorder-7 Total Score at Day 15 (Double-Blind Treatment Phase)- ANCOVA Analysis	0.4 Unit on a scale Standard Error 1.02	-1.6 Unit on a scale Standard Error 0.87	1.0 Unit on a scale Standard Error 0.98	-0.9 Unit on a scale Standard Error 1.02	-2.7 Unit on a scale Standard Error 1.68	-6.6 Unit on a scale Standard Error 1.68	-0.7 Unit on a scale Standard Error 2.27

SECONDARY outcome

Timeframe: Baseline (Day 1) and Endpoint (Day 8) of Period 1

Population: Period 1 ITT analysis set included all participants randomly assigned to treatment in period 1.

PGI-S is a patient-rated scale that assesses the severity of their illness at the time of assessment, relative to participants past experience. It is a 4-point (1 to 4) scale in response to the question 'Considering all aspects of your depression right now would you say your depression is?' with scores as follows: 1: none; 2: mild; 3: moderate; 4: severe. A higher score implies a more severe condition.

Outcome measures

Outcome measures
Measure	Panel A: Period 2 Placebo n=33 Participants Participants who were non-responders at the end of Period 1 in Panel A (with Quick Inventory of Depressive Symptomatology - 16-item Self Report (QIDS-SR16) score \>=11) were randomly re-assigned to receive same Placebo (1 spray to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 28 mg n=11 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR 16 score \>=11) were randomly re-assigned to receive esketamine 28 mg (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 56 mg n=11 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score \>=11) were randomly re-assigned to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 84 mg n=12 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR 16 score \>=11) were randomly re-assigned to receive esketamine 84 mg (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel B: Period 2 Placebo n=21 Participants Participants who were non-responders with QIDS-SR 16 score \>=11 received placebo intranasally (1 spray of placebo into each nostril at 0 and 5 minutes) on Days 8 and 11 of Period 2.	Panel B: Period 2 Esketamine 14 mg n=11 Participants Participants who received placebo in Period 1 and were non-responders with QIDS-SR16 score \>=11 received esketamine 14 mg intranasally (1 spray of esketamine into one nostril and 1 spray of placebo in other nostril at 0 minutes and 1 spray of placebo in each nostril at 5 minutes) in Period 2.	Panel B: Period 2 Esketamine 56 mg n=9 Participants Participants who were responders (with QIDS-SR16 score \<11) at the end of Period 1 in Panel B continued to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 in Period 2.
Panel A and B: Change From Baseline (Day 1) in Patient Global Impression of Severity (PGI-S) Score Total Score at Day 8 in the Double-Blind Treatment Phase- ANCOVA Analysis on Ranks	3.0 Unit on a scale Interval 2.0 to 4.0	3.0 Unit on a scale Interval 1.0 to 4.0	3.0 Unit on a scale Interval 1.0 to 3.0	3.0 Unit on a scale Interval 1.0 to 4.0	3.0 Unit on a scale Interval 2.0 to 4.0	3.0 Unit on a scale Interval 1.0 to 3.0	3.0 Unit on a scale Interval 2.0 to 3.0

SECONDARY outcome

Timeframe: Baseline (Day 8) and Endpoint (Day 15) of Period 2

Outcome measures

Outcome measures
Measure	Panel A: Period 2 Placebo n=6 Participants Participants who were non-responders at the end of Period 1 in Panel A (with Quick Inventory of Depressive Symptomatology - 16-item Self Report (QIDS-SR16) score \>=11) were randomly re-assigned to receive same Placebo (1 spray to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 28 mg n=8 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR 16 score \>=11) were randomly re-assigned to receive esketamine 28 mg (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 56 mg n=9 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score \>=11) were randomly re-assigned to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 of Period 2.	Panel A: Period 2 Esketamine 84 mg n=5 Participants Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR 16 score \>=11) were randomly re-assigned to receive esketamine 84 mg (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2.	Panel B: Period 2 Placebo n=5 Participants Participants who were non-responders with QIDS-SR 16 score \>=11 received placebo intranasally (1 spray of placebo into each nostril at 0 and 5 minutes) on Days 8 and 11 of Period 2.	Panel B: Period 2 Esketamine 14 mg n=5 Participants Participants who received placebo in Period 1 and were non-responders with QIDS-SR16 score \>=11 received esketamine 14 mg intranasally (1 spray of esketamine into one nostril and 1 spray of placebo in other nostril at 0 minutes and 1 spray of placebo in each nostril at 5 minutes) in Period 2.	Panel B: Period 2 Esketamine 56 mg n=3 Participants Participants who were responders (with QIDS-SR16 score \<11) at the end of Period 1 in Panel B continued to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 in Period 2.
Panel A and B: Change From Baseline (Day 8) in Patient Global Impression of Severity Score Total Score at Day 15 in the Double-Blind Treatment Phase- ANCOVA Analysis on Ranks	3.0 Unit on a scale Interval 2.0 to 4.0	3.0 Unit on a scale Interval 2.0 to 4.0	4.0 Unit on a scale Interval 2.0 to 4.0	3.0 Unit on a scale Interval 2.0 to 4.0	3.0 Unit on a scale Interval 2.0 to 3.0	3.0 Unit on a scale Interval 2.0 to 3.0	3.0 Unit on a scale Interval 2.0 to 4.0

Adverse Events

Placebo (Panel A and B: Period 1)

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Esketamine 28 mg (Panel A: Period 1)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo (Panel A and B: Period 2) QIDS >=11 Participants

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Placebo to Esketamine 14mg (Panel B: Period 2)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo to Esketamine 28mg (Panel A: Period 2)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo to Esketamine 56mg (Panel A and B: Period 2)

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo to Esketamine 84 mg (Panel A: Period 2)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo (Panel A and Panel B: Period 2)

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Esketamine 14 mg (Panel B: Period 2)

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Esketamine 28 mg (Panel A: Period 2)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Esketamine 56 mg (Panel A and B: Period 2)

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Placebo/Placebo/Open Label Esketamine (Panel A and B)

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Placebo/Esketamine/Open Label Esketamine (Panel A and B)

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Esketamine/Esketamine/Open Label Esketamine (Panel A and B)

Serious events: 1 serious events

Other events: 39 other events

Deaths: 0 deaths

Placebo: Follow up Phase

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Esketamine 14 mg: Follow up Phase

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Esketamine 28 mg: Follow up Phase

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Esketamine 56 mg: Follow up Phase

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Esketamine 84 mg: Follow up Phase

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Esketamine 14 mg (Panel B: Period 1)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Esketamine 56 mg (Panel A and B: Period 1)

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Esketamine 84 mg (Panel A: Period 1)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Esketamine 84 mg (Panel A: Period 2)

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo (Panel A and B: Period 1) n=54 participants at risk Panel A: Participants self-administered placebo intranasally (1 spray to each nostril at 0, 5 and 10 minutes) on Days 1 and 4 of Period 1 in Panel A. Panel B: Participants self-administered placebo intranasally (1 spray to each nostril at 0 and 5 minutes) on Days 1 and 4 of Period 1 in Panel B.	Esketamine 28 mg (Panel A: Period 1) n=11 participants at risk Participants self administered esketamine 28 milligram (mg) intranasally (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 1 and 4 of Period 1 in Panel A.	Placebo (Panel A and B: Period 2) QIDS >=11 Participants n=23 participants at risk Panel A: Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score \>=11) were randomly reassigned to receive same Placebo (1 spray to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2 in Panel A. Panel B: Participants who were non-responders with QIDS-SR16 score \>=11 at the end of Period 1 were randomly assigned to receive placebo intranasally (1 spray of placebo into each nostril at 0 and 5 minutes using 4 separate devices) on Days 8 and 11 of Period 2 in Panel B.	Placebo to Esketamine 14mg (Panel B: Period 2) n=5 participants at risk Participants who received placebo in Period 1 and were non-responders with QIDS-SR16 score \>=11 at the end of Period 1 were randomly reassigned to receive esketamine 14 mg intranasally (1 spray of esketamine 14 mg into once nostril and 1 spray of placebo in other nostril at 0 minute and 1 spray of placebo in each nostril at 5 minutes using 4 separate devices) on Days 8 and 11 in Period 2 of Panel B.	Placebo to Esketamine 28mg (Panel A: Period 2) n=8 participants at risk Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score \>=11) were randomly reassigned to receive esketamine 28 mg (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 8 and 11 of Period 2 in Panel A.	Placebo to Esketamine 56mg (Panel A and B: Period 2) n=12 participants at risk Panel A: Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score \>=11) were randomly reassigned to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 of Period 2 in Panel A. Panel B: Participants who were responders (with QIDS-SR16 score \<11) at the end of Period 1 in Panel B continued to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 in Period 2 of Panel B.	Placebo to Esketamine 84 mg (Panel A: Period 2) n=5 participants at risk Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score \>=11) were randomly reassigned to receive esketamine 84 mg (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2 in Panel A.	Placebo (Panel A and Panel B: Period 2) n=23 participants at risk All participants who received placebo in Period 2 of Panel A and B (including participants with QIDS-SR16 score \>=11 and QIDS-SR16 score \<11) in double-blind phase.	Esketamine 14 mg (Panel B: Period 2) n=16 participants at risk Participants who received esketamine 14 mg in Period 1 of Panel B continued to receive esketamine 14 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 in Period 2 of Panel B.	Esketamine 28 mg (Panel A: Period 2) n=16 participants at risk Participants who received esketamine 28 mg in Period 1 of Panel A continued to receive esketamine 28 mg (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 8 and 11 of Period 2 in Panel A.	Esketamine 56 mg (Panel A and B: Period 2) n=32 participants at risk Panel A: Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score \>=11) were randomly re-assigned to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 of Period 2. Panel B: Participants who were responders (with QIDS-SR16 score \<11) at the end of Period 1 in Panel B continued to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 in Period 2.	Placebo/Placebo/Open Label Esketamine (Panel A and B) n=23 participants at risk Panel A: Participants who received Placebo in Period 1 and 2 of Panel A and elected to continue with open label (OL) phase received up to 9 single doses of intranasal esketamine on Days 15,18,22,25,32, 39, 46,60,74. Doses for optional OL phase included 28, 56, and 84 mg of esketamine. All participants started with intranasal esketamine 56 mg on Day 15. Subsequent doses on Days 18,22,25,32,39,46 could be adjusted to next lower or higher dose, based on investigator's clinical judgment. Same dose administered on Day 46 was administered on Day 60, 74. Panel B: Participants who received Placebo in Period 1 and 2 of Panel A and elected to continue with OL phase received up to 4 single doses of intranasal esketamine on Days 15, 18, 22, 25. Doses for OL phase included 14, 28, 56 mg of esketamine. All participants started with intranasal esketamine 56 mg on Day 15. Subsequent doses on Days 18, 22, 25 could be adjusted to next lower or higher dose, based on investigator's clinical judgment.	Placebo/Esketamine/Open Label Esketamine (Panel A and B) n=27 participants at risk Panel A: Participants who received Placebo in Period 1, esketamine in Period 2 and elected to continue with OL phase received up to 9 single doses of intranasal esketamine on Days 15,18,22,25,32,39,46,60, 74. Doses for OL phase included 28,56,84 mg of esketamine. All participants started with intranasal esketamine 56 mg on Day 15. Subsequent doses on Days 18,22,25,32,39, 46 could be adjusted to the next lower or higher dose, based on the investigator's clinical judgment. Same dose administered on Day 46 was administered on Day 60,74. Panel B: Participants who received Placebo in Period 1 and esketamine in Period 2 of Panel A and elected to continue with OL phase received up to 4 single doses of intranasal esketamine on Days 15,18,22,25. Doses for OL phase included 14,28,56 mg of esketamine. All participants started with intranasal esketamine 56 mg on Day 15. Subsequent doses on Days 18,22,25 could be adjusted to next lower or higher dose, based on the investigator's clinical judgment.	Esketamine/Esketamine/Open Label Esketamine (Panel A and B) n=46 participants at risk Panel A: Participants who received esketamine in Period 1 and 2 and elected to continue with open label phase received up to 9 single doses of intranasal esketamine on Days 15,18,22,25,32,39,46,60,74. Doses for OL treatment phase included 28, 56, 84 mg of esketamine. All participants started with intranasal esketamine 56 mg on Day 15. Subsequent doses on Days 18, 22,25,32,39, 46 could be adjusted to the next lower or higher dose, based on the investigator's clinical judgment. Same dose administered on Day 46 was administered on Day 60,74.Panel B: Participants who received esketamine in Period 1 and 2 of Panel A and elected to continue with OL phase received up to 4 single doses of intranasal esketamine on Days 15, 18, 22, 25. Doses for OL phase included 14, 28, 56 mg of esketamine. All participants started with intranasal esketamine 56 mg on Day 15. Subsequent doses on Days 18, 22, 25 could be adjusted to the next lower or higher dose, based on the investigator's clinical judgment.	Placebo: Follow up Phase n=1 participants at risk All participants whose last dose was Placebo in the double-blind phase or open label phase and were not consent withdrawn were followed for safety for 8 weeks.	Esketamine 14 mg: Follow up Phase n=4 participants at risk All participants whose last dose was esketamine 14 mg in the double-blind phase or open label phase and were not consent withdrawn were followed for safety for 8 weeks.	Esketamine 28 mg: Follow up Phase n=12 participants at risk All participants whose last dose was esketamine 28 mg in the double-blind phase or open label phase and were not consent withdrawn were followed for safety for 8 weeks.	Esketamine 56 mg: Follow up Phase n=39 participants at risk All participants whose last dose was esketamine 56 mg in the double-blind phase or open label phase and were not consent withdrawn were followed for safety for 8 weeks.	Esketamine 84 mg: Follow up Phase n=42 participants at risk All participants whose last dose was esketamine 84 mg in the double-blind phase or open label phase and were not consent withdrawn were followed for safety for 8 weeks.	Esketamine 14 mg (Panel B: Period 1) n=11 participants at risk Participants self administered esketamine 14 mg intranasally (1 spray of esketamine 14 mg into one nostril and 1 spray of placebo into other nostril at 0 minute and then 1 spray of placebo to each nostril at 5 minutes) on Days 1 and 4 of Period 1 in Panel B.	Esketamine 56 mg (Panel A and B: Period 1) n=20 participants at risk Panel A: Participants self administered esketamine 56 mg intranasally (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 1 and 4 of Period 1. Panel B: Participants self administered esketamine 56 mg intranasally (1 spray of esketamine 14 mg into each nostril at 0 and 5 minutes) on Days 1 and 4 of Period 1.	Esketamine 84 mg (Panel A: Period 1) n=12 participants at risk Participants self administered esketamine 84 mg intranasally (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) on Days 1 and 4 of Period 1 in Panel A.	Esketamine 84 mg (Panel A: Period 2) n=17 participants at risk Participants who received esketamine 84 mg in Period 1 of Panel A continued to receive esketamine 84 mg (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2 in Panel A.
Psychiatric disorders Confusional State	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/3 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Gastrointestinal disorders Oesophagitis	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 1/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 1/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
General disorders General Physical Health Deterioration	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/3 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.4% 1/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Pregnancy, puerperium and perinatal conditions Ectopic Pregnancy	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/3 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.2% 1/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Psychiatric disorders Completed Suicide	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/3 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.6% 1/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.

Other adverse events

Other adverse events
Measure	Placebo (Panel A and B: Period 1) n=54 participants at risk Panel A: Participants self-administered placebo intranasally (1 spray to each nostril at 0, 5 and 10 minutes) on Days 1 and 4 of Period 1 in Panel A. Panel B: Participants self-administered placebo intranasally (1 spray to each nostril at 0 and 5 minutes) on Days 1 and 4 of Period 1 in Panel B.	Esketamine 28 mg (Panel A: Period 1) n=11 participants at risk Participants self administered esketamine 28 milligram (mg) intranasally (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 1 and 4 of Period 1 in Panel A.	Placebo (Panel A and B: Period 2) QIDS >=11 Participants n=23 participants at risk Panel A: Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score \>=11) were randomly reassigned to receive same Placebo (1 spray to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2 in Panel A. Panel B: Participants who were non-responders with QIDS-SR16 score \>=11 at the end of Period 1 were randomly assigned to receive placebo intranasally (1 spray of placebo into each nostril at 0 and 5 minutes using 4 separate devices) on Days 8 and 11 of Period 2 in Panel B.	Placebo to Esketamine 14mg (Panel B: Period 2) n=5 participants at risk Participants who received placebo in Period 1 and were non-responders with QIDS-SR16 score \>=11 at the end of Period 1 were randomly reassigned to receive esketamine 14 mg intranasally (1 spray of esketamine 14 mg into once nostril and 1 spray of placebo in other nostril at 0 minute and 1 spray of placebo in each nostril at 5 minutes using 4 separate devices) on Days 8 and 11 in Period 2 of Panel B.	Placebo to Esketamine 28mg (Panel A: Period 2) n=8 participants at risk Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score \>=11) were randomly reassigned to receive esketamine 28 mg (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 8 and 11 of Period 2 in Panel A.	Placebo to Esketamine 56mg (Panel A and B: Period 2) n=12 participants at risk Panel A: Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score \>=11) were randomly reassigned to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 of Period 2 in Panel A. Panel B: Participants who were responders (with QIDS-SR16 score \<11) at the end of Period 1 in Panel B continued to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 in Period 2 of Panel B.	Placebo to Esketamine 84 mg (Panel A: Period 2) n=5 participants at risk Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score \>=11) were randomly reassigned to receive esketamine 84 mg (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2 in Panel A.	Placebo (Panel A and Panel B: Period 2) n=23 participants at risk All participants who received placebo in Period 2 of Panel A and B (including participants with QIDS-SR16 score \>=11 and QIDS-SR16 score \<11) in double-blind phase.	Esketamine 14 mg (Panel B: Period 2) n=16 participants at risk Participants who received esketamine 14 mg in Period 1 of Panel B continued to receive esketamine 14 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 in Period 2 of Panel B.	Esketamine 28 mg (Panel A: Period 2) n=16 participants at risk Participants who received esketamine 28 mg in Period 1 of Panel A continued to receive esketamine 28 mg (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 8 and 11 of Period 2 in Panel A.	Esketamine 56 mg (Panel A and B: Period 2) n=32 participants at risk Panel A: Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score \>=11) were randomly re-assigned to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 of Period 2. Panel B: Participants who were responders (with QIDS-SR16 score \<11) at the end of Period 1 in Panel B continued to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 in Period 2.	Placebo/Placebo/Open Label Esketamine (Panel A and B) n=23 participants at risk Panel A: Participants who received Placebo in Period 1 and 2 of Panel A and elected to continue with open label (OL) phase received up to 9 single doses of intranasal esketamine on Days 15,18,22,25,32, 39, 46,60,74. Doses for optional OL phase included 28, 56, and 84 mg of esketamine. All participants started with intranasal esketamine 56 mg on Day 15. Subsequent doses on Days 18,22,25,32,39,46 could be adjusted to next lower or higher dose, based on investigator's clinical judgment. Same dose administered on Day 46 was administered on Day 60, 74. Panel B: Participants who received Placebo in Period 1 and 2 of Panel A and elected to continue with OL phase received up to 4 single doses of intranasal esketamine on Days 15, 18, 22, 25. Doses for OL phase included 14, 28, 56 mg of esketamine. All participants started with intranasal esketamine 56 mg on Day 15. Subsequent doses on Days 18, 22, 25 could be adjusted to next lower or higher dose, based on investigator's clinical judgment.	Placebo/Esketamine/Open Label Esketamine (Panel A and B) n=27 participants at risk Panel A: Participants who received Placebo in Period 1, esketamine in Period 2 and elected to continue with OL phase received up to 9 single doses of intranasal esketamine on Days 15,18,22,25,32,39,46,60, 74. Doses for OL phase included 28,56,84 mg of esketamine. All participants started with intranasal esketamine 56 mg on Day 15. Subsequent doses on Days 18,22,25,32,39, 46 could be adjusted to the next lower or higher dose, based on the investigator's clinical judgment. Same dose administered on Day 46 was administered on Day 60,74. Panel B: Participants who received Placebo in Period 1 and esketamine in Period 2 of Panel A and elected to continue with OL phase received up to 4 single doses of intranasal esketamine on Days 15,18,22,25. Doses for OL phase included 14,28,56 mg of esketamine. All participants started with intranasal esketamine 56 mg on Day 15. Subsequent doses on Days 18,22,25 could be adjusted to next lower or higher dose, based on the investigator's clinical judgment.	Esketamine/Esketamine/Open Label Esketamine (Panel A and B) n=46 participants at risk Panel A: Participants who received esketamine in Period 1 and 2 and elected to continue with open label phase received up to 9 single doses of intranasal esketamine on Days 15,18,22,25,32,39,46,60,74. Doses for OL treatment phase included 28, 56, 84 mg of esketamine. All participants started with intranasal esketamine 56 mg on Day 15. Subsequent doses on Days 18, 22,25,32,39, 46 could be adjusted to the next lower or higher dose, based on the investigator's clinical judgment. Same dose administered on Day 46 was administered on Day 60,74.Panel B: Participants who received esketamine in Period 1 and 2 of Panel A and elected to continue with OL phase received up to 4 single doses of intranasal esketamine on Days 15, 18, 22, 25. Doses for OL phase included 14, 28, 56 mg of esketamine. All participants started with intranasal esketamine 56 mg on Day 15. Subsequent doses on Days 18, 22, 25 could be adjusted to the next lower or higher dose, based on the investigator's clinical judgment.	Placebo: Follow up Phase n=1 participants at risk All participants whose last dose was Placebo in the double-blind phase or open label phase and were not consent withdrawn were followed for safety for 8 weeks.	Esketamine 14 mg: Follow up Phase n=4 participants at risk All participants whose last dose was esketamine 14 mg in the double-blind phase or open label phase and were not consent withdrawn were followed for safety for 8 weeks.	Esketamine 28 mg: Follow up Phase n=12 participants at risk All participants whose last dose was esketamine 28 mg in the double-blind phase or open label phase and were not consent withdrawn were followed for safety for 8 weeks.	Esketamine 56 mg: Follow up Phase n=39 participants at risk All participants whose last dose was esketamine 56 mg in the double-blind phase or open label phase and were not consent withdrawn were followed for safety for 8 weeks.	Esketamine 84 mg: Follow up Phase n=42 participants at risk All participants whose last dose was esketamine 84 mg in the double-blind phase or open label phase and were not consent withdrawn were followed for safety for 8 weeks.	Esketamine 14 mg (Panel B: Period 1) n=11 participants at risk Participants self administered esketamine 14 mg intranasally (1 spray of esketamine 14 mg into one nostril and 1 spray of placebo into other nostril at 0 minute and then 1 spray of placebo to each nostril at 5 minutes) on Days 1 and 4 of Period 1 in Panel B.	Esketamine 56 mg (Panel A and B: Period 1) n=20 participants at risk Panel A: Participants self administered esketamine 56 mg intranasally (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 1 and 4 of Period 1. Panel B: Participants self administered esketamine 56 mg intranasally (1 spray of esketamine 14 mg into each nostril at 0 and 5 minutes) on Days 1 and 4 of Period 1.	Esketamine 84 mg (Panel A: Period 1) n=12 participants at risk Participants self administered esketamine 84 mg intranasally (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) on Days 1 and 4 of Period 1 in Panel A.	Esketamine 84 mg (Panel A: Period 2) n=17 participants at risk Participants who received esketamine 84 mg in Period 1 of Panel A continued to receive esketamine 84 mg (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2 in Panel A.
General disorders Thirst	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.1% 1/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Infections and infestations Cystitis	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.7% 1/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	5.0% 1/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Infections and infestations Nasopharyngitis	1.9% 1/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 1/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.7% 1/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 2/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	12.8% 5/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.4% 1/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	5.0% 1/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
General disorders Pyrexia	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	5.0% 1/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
General disorders Sluggishness	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	5.0% 1/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Cardiac disorders Bradycardia	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	9.1% 1/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Cardiac disorders Palpitations	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 1/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 1/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.2% 1/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.1% 1/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.2% 1/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Cardiac disorders Sinus Bradycardia	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.2% 1/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Ear and labyrinth disorders Ear Congestion	1.9% 1/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Ear and labyrinth disorders Vertigo	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	9.1% 1/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	16.7% 2/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.2% 1/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.2% 2/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.7% 2/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	11.1% 3/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 2/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	5.9% 1/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Eye disorders Accommodation Disorder	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.7% 1/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.2% 1/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	9.1% 1/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Eye disorders Conjunctival Hyperaemia	1.9% 1/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Eye disorders Vision Blurred	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	20.0% 1/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.2% 1/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 1/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.7% 1/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.2% 1/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	11.8% 2/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Eye disorders Visual Impairment	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 1/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.7% 1/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.5% 3/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	9.1% 1/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	5.0% 1/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Gastrointestinal disorders Abdominal Pain	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 1/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	5.0% 1/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.2% 1/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.2% 1/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Gastrointestinal disorders Hypoaesthesia Oral	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	9.1% 1/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	16.7% 2/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	20.0% 1/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	9.4% 3/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.7% 2/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.7% 1/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 2/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	15.0% 3/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	11.8% 2/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Gastrointestinal disorders Nausea	9.3% 5/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	18.2% 2/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	13.0% 3/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	20.0% 1/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	16.7% 2/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	40.0% 2/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.7% 2/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.2% 1/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.2% 1/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	9.4% 3/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	17.4% 4/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	22.2% 6/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	13.0% 6/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	9.1% 1/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	25.0% 5/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	16.7% 2/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	11.8% 2/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Gastrointestinal disorders Oral Discomfort	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.1% 1/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.7% 1/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.2% 1/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Gastrointestinal disorders Paraesthesia Oral	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	9.1% 1/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.1% 1/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.7% 2/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.5% 3/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	5.0% 1/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Gastrointestinal disorders Salivary Hypersecretion	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.1% 1/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.2% 1/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Gastrointestinal disorders Stomatitis	1.9% 1/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Gastrointestinal disorders Vomiting	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.1% 1/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	11.1% 3/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.5% 3/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.6% 1/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	9.1% 1/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	5.0% 1/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
General disorders Asthenia	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.7% 2/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.7% 2/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.7% 2/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 2/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.6% 1/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	9.1% 1/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
General disorders Chills	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.2% 1/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	9.1% 1/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
General disorders Discomfort	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.1% 1/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.2% 1/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	5.0% 1/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
General disorders Energy Increased	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	5.9% 1/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
General disorders Feeling Abnormal	1.9% 1/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	18.2% 2/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 1/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	40.0% 2/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 1/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	25.0% 4/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	9.4% 3/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	17.4% 4/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	14.8% 4/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	15.2% 7/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	18.2% 2/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	20.0% 4/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	5.9% 1/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
General disorders Feeling Drunk	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.2% 1/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.1% 1/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 1/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.5% 3/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
General disorders Feeling Hot	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.1% 1/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.2% 1/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
General disorders Feeling Jittery	1.9% 1/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	12.5% 1/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
General disorders Gait Disturbance	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.1% 1/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.7% 1/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
General disorders Hangover	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.2% 1/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.2% 1/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
General disorders Injection Site Haemorrhage	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.2% 1/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
General disorders Malaise	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.1% 1/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.7% 2/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.7% 1/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.2% 1/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.6% 1/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
General disorders Pain	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
General disorders Product Taste Abnormal	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	5.9% 1/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Injury, poisoning and procedural complications Contusion	1.9% 1/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 1/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.2% 1/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Injury, poisoning and procedural complications Scratch	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.2% 1/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	5.0% 1/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Injury, poisoning and procedural complications Skin Abrasion	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.2% 1/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Investigations Blood Pressure Diastolic Increased	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	12.5% 1/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.2% 1/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.7% 1/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.2% 1/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	5.0% 1/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Investigations Blood Pressure Increased	1.9% 1/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 1/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	20.0% 1/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	20.0% 1/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 1/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.2% 1/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.1% 1/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	17.4% 4/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	11.1% 3/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.5% 3/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	10.0% 2/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	5.9% 1/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Investigations Blood Pressure Systolic Increased	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	9.1% 1/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Respiratory, thoracic and mediastinal disorders Nasal Dryness	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.1% 1/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	5.9% 1/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Investigations Oxygen Saturation Decreased	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	20.0% 1/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.2% 1/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.2% 1/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Metabolism and nutrition disorders Decreased Appetite	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.2% 1/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.6% 1/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.4% 1/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	9.1% 1/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	5.0% 1/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Musculoskeletal and connective tissue disorders Back Pain	1.9% 1/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.7% 1/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Musculoskeletal and connective tissue disorders Limb Discomfort	1.9% 1/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 1/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Musculoskeletal and connective tissue disorders Muscle Tightness	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.1% 1/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.2% 1/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	5.0% 1/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	5.9% 1/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	9.1% 1/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Nervous system disorders Akathisia	1.9% 1/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	20.0% 1/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Nervous system disorders Altered State of Consciousness	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.1% 1/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Nervous system disorders Coordination Abnormal	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.1% 1/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.7% 1/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Nervous system disorders Disturbance in Attention	1.9% 1/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 1/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Nervous system disorders Dizziness	1.9% 1/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	36.4% 4/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	40.0% 2/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	33.3% 4/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	60.0% 3/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	12.5% 2/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	12.5% 2/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	34.4% 11/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	30.4% 7/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	33.3% 9/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	30.4% 14/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	9.1% 1/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	35.0% 7/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	41.7% 5/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	29.4% 5/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Nervous system disorders Dizziness Postural	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.2% 2/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.7% 2/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.7% 4/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.6% 1/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Nervous system disorders Dysaesthesia	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 1/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.2% 1/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	9.1% 1/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Nervous system disorders Dysgeusia	16.7% 9/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	18.2% 2/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	26.1% 6/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	20.0% 1/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	12.5% 1/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	16.7% 2/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	60.0% 3/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	17.4% 4/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	12.5% 2/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.2% 1/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	12.5% 4/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	17.4% 4/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	22.2% 6/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	19.6% 9/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	9.1% 1/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	20.0% 4/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	25.0% 3/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	23.5% 4/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Nervous system disorders Dysgraphia	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.1% 1/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.7% 1/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.2% 1/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	5.0% 1/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Nervous system disorders Dyskinesia	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.2% 1/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	5.0% 1/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Nervous system disorders Headache	7.4% 4/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	36.4% 4/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	21.7% 5/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	25.0% 2/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	25.0% 3/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	20.0% 1/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	17.4% 4/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.2% 1/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	12.5% 2/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	9.4% 3/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	17.4% 4/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	18.5% 5/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	10.9% 5/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	25.0% 1/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	9.5% 4/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	18.2% 2/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	20.0% 4/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	16.7% 2/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	5.9% 1/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Nervous system disorders Hypersomnia	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	9.1% 1/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.2% 1/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Nervous system disorders Hypoaesthesia	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	9.1% 1/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 1/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	20.0% 1/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 1/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	18.8% 3/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	12.5% 4/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	13.0% 3/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	14.8% 4/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	17.4% 8/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	9.1% 1/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	15.0% 3/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Nervous system disorders Loss of Consciousness	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.2% 1/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Nervous system disorders Mental Impairment	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.1% 1/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.7% 1/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 2/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Nervous system disorders Paraesthesia	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 1/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.2% 1/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.4% 1/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Nervous system disorders Psychomotor Hyperactivity	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	12.5% 1/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.2% 1/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Nervous system disorders Sedation	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	12.5% 1/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	20.0% 1/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.2% 1/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.1% 1/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	13.0% 3/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	7.4% 2/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.5% 3/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	15.0% 3/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	5.9% 1/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Nervous system disorders Slow Speech	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 2/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Nervous system disorders Somnolence	5.6% 3/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	9.1% 1/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	30.4% 7/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	20.0% 1/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	16.7% 2/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	26.1% 6/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.2% 1/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.2% 1/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	15.6% 5/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	30.4% 7/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	18.5% 5/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	10.9% 5/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	18.2% 2/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	10.0% 2/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Nervous system disorders Syncope	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	9.1% 1/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Nervous system disorders Tremor	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.7% 1/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.2% 1/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.6% 1/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	9.1% 1/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Nervous system disorders Tunnel Vision	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.7% 1/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.2% 1/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	16.7% 2/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	5.9% 1/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Nervous system disorders Visual Field Defect	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.1% 1/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.2% 1/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	5.0% 1/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Psychiatric disorders Anxiety	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.1% 1/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.7% 1/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Psychiatric disorders Confusional State	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.1% 1/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Psychiatric disorders Daydreaming	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.2% 1/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Psychiatric disorders Dissociation	1.9% 1/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	20.0% 1/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	33.3% 4/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	20.0% 1/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.2% 1/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	25.0% 8/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.7% 2/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	14.8% 4/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	17.4% 8/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	30.0% 6/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	25.0% 3/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	11.8% 2/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Psychiatric disorders Dissociative Disorder	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	9.1% 1/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	12.5% 1/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	20.0% 1/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.2% 1/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.1% 1/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	17.4% 4/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	7.4% 2/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.5% 3/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	5.0% 1/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	25.0% 3/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	17.6% 3/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Psychiatric disorders Dysphoria	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Psychiatric disorders Fear	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.1% 1/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Psychiatric disorders Hallucination, Visual	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	12.5% 1/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.2% 1/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.1% 1/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	7.4% 2/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 2/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	5.0% 1/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Psychiatric disorders Illusion	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.2% 1/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 1/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 2/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	5.0% 1/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Psychiatric disorders Insomnia	1.9% 1/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 1/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	16.7% 2/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.2% 2/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	25.0% 1/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.6% 1/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Psychiatric disorders Irritability	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 1/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 1/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	7.4% 2/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.2% 1/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Psychiatric disorders Merycism	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Psychiatric disorders Somatic Hallucination	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.1% 1/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Psychiatric disorders Suspiciousness	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	5.0% 1/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Psychiatric disorders Thinking Abnormal	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 1/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.7% 1/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.2% 1/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	5.0% 1/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Renal and urinary disorders Bladder Pain	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.1% 1/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Renal and urinary disorders Micturition Urgency	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.1% 1/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Renal and urinary disorders Polyuria	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.1% 1/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	5.0% 1/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Respiratory, thoracic and mediastinal disorders Dry Throat	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.1% 1/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 1/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 1/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.5% 3/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Gastrointestinal disorders Oesophageal Stenosis	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 1/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Respiratory, thoracic and mediastinal disorders Hyperventilation	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.1% 1/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.7% 1/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	1.9% 1/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	20.0% 1/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	5.9% 1/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Respiratory, thoracic and mediastinal disorders Nasal Discomfort	5.6% 3/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.7% 2/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	16.7% 2/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.1% 1/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	13.0% 3/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	7.4% 2/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	5.0% 1/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Respiratory, thoracic and mediastinal disorders Nasal Mucosal Disorder	1.9% 1/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	9.1% 1/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Respiratory, thoracic and mediastinal disorders Nasal Obstruction	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.1% 1/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Respiratory, thoracic and mediastinal disorders Nasal Oedema	1.9% 1/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	20.0% 1/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Respiratory, thoracic and mediastinal disorders Nasal Pruritus	3.7% 2/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	20.0% 1/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	9.1% 1/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	3.7% 2/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.7% 2/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	20.0% 1/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 1/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.2% 1/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.7% 2/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	7.4% 2/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.5% 3/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	5.0% 1/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	5.9% 1/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Respiratory, thoracic and mediastinal disorders Pharyngeal Disorder	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	20.0% 1/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.2% 1/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Respiratory, thoracic and mediastinal disorders Pharyngeal Hypoaesthesia	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	20.0% 1/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.2% 1/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	5.9% 1/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.1% 1/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 1/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.7% 1/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.6% 1/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	9.1% 1/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Respiratory, thoracic and mediastinal disorders Sneezing	1.9% 1/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	9.1% 1/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	12.5% 1/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 1/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Respiratory, thoracic and mediastinal disorders Throat Irritation	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	9.1% 1/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	20.0% 1/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.1% 1/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.7% 2/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	7.4% 2/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.5% 3/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	11.8% 2/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Respiratory, thoracic and mediastinal disorders Upper-Airway Cough Syndrome	3.7% 2/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	20.0% 1/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Skin and subcutaneous tissue disorders Dermatitis Contact	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	16.7% 2/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.2% 2/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.1% 1/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Skin and subcutaneous tissue disorders Scab	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.2% 1/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.7% 1/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Vascular disorders Hot Flush	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	9.1% 1/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 1/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Vascular disorders Hypertension	3.7% 2/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	25.0% 3/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	6.2% 1/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	9.4% 3/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.7% 1/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 2/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	5.0% 1/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	5.9% 1/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Vascular disorders Peripheral Coldness	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.1% 1/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 2/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	10.0% 2/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Cardiac disorders Sinus Tachycardia	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/3 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Eye disorders Conjunctivitis Allergic	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 1/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Gastrointestinal disorders Dry Mouth	1.9% 1/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Gastrointestinal disorders Diarrhoea	1.9% 1/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 1/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Gastrointestinal disorders Erosive Oesophagitis	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 1/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Gastrointestinal disorders Gastritis	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 1/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Infections and infestations Gastroenteritis	1.9% 1/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Infections and infestations Pharyngitis	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.2% 1/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Injury, poisoning and procedural complications Arthropod Bite	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Investigations C-Reactive Protein Increased	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Musculoskeletal and connective tissue disorders Muscle Spasms	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 1/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Nervous system disorders Dysarthria	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	3.7% 1/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Nervous system disorders Sensory Disturbance	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 1/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Psychiatric disorders Depersonalisation	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.7% 2/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	2.2% 1/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Psychiatric disorders Persecutory Delusion	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	8.3% 1/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Psychiatric disorders Suicidal Ideation	0.00% 0/54 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	4.3% 1/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/8 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/5 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/16 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/32 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/23 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/27 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/46 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/1 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/4 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/39 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/42 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/11 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/20 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/12 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.	0.00% 0/17 • Up to 21 weeks Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.

Additional Information

Senior Director

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Publication restrictions are in place

Restriction type: OTHER