Trial Outcomes & Findings for Study of the Safety, Tolerability, and Pharmacokinetics of Once Weekly Zicronapine in Patients With Schizophrenia (NCT NCT01377233)

Last Updated: 2016-03-22

Results Overview

Number of patients with treatment-emergent adverse events during each of the two study periods plus corresponding safety follow-up period. Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

46 participants

Primary outcome timeframe

11 weeks for open-label period; 13 weeks for double-blind period

Results posted on

2016-03-22

Participant Flow

46 patients were initially enrolled in a 3-week open-label study period. The 42 patients who completed the open-label period were subsequently randomized to a 5-week double-blind period.

Participant milestones

Participant milestones
Measure	Zicronapine Open-label 10 mg Daily Zicronapine open-label 10 mg daily: Encapsulated tablet ,10 mg, once daily, open-label	Zicronapine Basis Dose 10 mg Daily Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind	Zicronapine Low Dose 20 mg Once Weekly Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind	Zicronapine Med Dose 30 mg Once Weekly Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind	Zicronapine High Dose 45 mg Once Weekly Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
Open-label STARTED	46	0	0	0	0
Open-label COMPLETED	42	0	0	0	0
Open-label NOT COMPLETED	4	0	0	0	0
Double-blind STARTED	0	11	10	11	10
Double-blind COMPLETED	0	10	8	7	8
Double-blind NOT COMPLETED	0	1	2	4	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Zicronapine Open-label 10 mg Daily Zicronapine open-label 10 mg daily: Encapsulated tablet ,10 mg, once daily, open-label	Zicronapine Basis Dose 10 mg Daily Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind	Zicronapine Low Dose 20 mg Once Weekly Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind	Zicronapine Med Dose 30 mg Once Weekly Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind	Zicronapine High Dose 45 mg Once Weekly Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
Open-label Adverse Event	1	0	0	0	0
Open-label Withdrawal by Subject	3	0	0	0	0
Double-blind Adverse Event	0	1	2	2	0
Double-blind Protocol Violation	0	0	0	0	1
Double-blind Withdrawal by Subject	0	0	0	1	0
Double-blind Administrative or other	0	0	0	1	1

Baseline Characteristics

Study of the Safety, Tolerability, and Pharmacokinetics of Once Weekly Zicronapine in Patients With Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Zicronapine Open-label 10 mg Daily n=4 Participants Zicronapine open-label 10 mg daily: Encapsulated tablet ,10 mg, once daily, open-label	Zicronapine 10 mg Daily n=11 Participants Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind	Zicronapine 20 mg Once Weekly n=10 Participants Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind	Zicronapine 30 mg Once Weekly n=11 Participants Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind	Zicronapine 45 mg Once Weekly n=10 Participants Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind	Total n=46 Participants Total of all reporting groups
Age, Continuous	38.5 years STANDARD_DEVIATION 6.6 • n=5 Participants	42.7 years STANDARD_DEVIATION 11.7 • n=7 Participants	47.8 years STANDARD_DEVIATION 6.4 • n=5 Participants	50.8 years STANDARD_DEVIATION 5.0 • n=4 Participants	50.1 years STANDARD_DEVIATION 4.8 • n=21 Participants	47.0 years STANDARD_DEVIATION 8.3 • n=10 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	17 Participants n=10 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants	6 Participants n=21 Participants	29 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	7 Participants n=7 Participants	5 Participants n=5 Participants	8 Participants n=4 Participants	7 Participants n=21 Participants	28 Participants n=10 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	16 Participants n=10 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
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
Region of Enrollment United States	4 participants n=5 Participants	11 participants n=7 Participants	10 participants n=5 Participants	11 participants n=4 Participants	10 participants n=21 Participants	46 participants n=10 Participants
Height	176.3 cm STANDARD_DEVIATION 9.4 • n=5 Participants	169.5 cm STANDARD_DEVIATION 8.3 • n=7 Participants	170.1 cm STANDARD_DEVIATION 9.7 • n=5 Participants	174.6 cm STANDARD_DEVIATION 10.3 • n=4 Participants	170.9 cm STANDARD_DEVIATION 11.7 • n=21 Participants	171.8 cm STANDARD_DEVIATION 9.8 • n=10 Participants
Weight	94.7 kg STANDARD_DEVIATION 27.5 • n=5 Participants	90.0 kg STANDARD_DEVIATION 21.1 • n=7 Participants	91.5 kg STANDARD_DEVIATION 19.2 • n=5 Participants	87.5 kg STANDARD_DEVIATION 17.5 • n=4 Participants	93.8 kg STANDARD_DEVIATION 16.8 • n=21 Participants	89.7 kg STANDARD_DEVIATION 18.0 • n=10 Participants
BMI	30.0 kg/m2 STANDARD_DEVIATION 5.5 • n=5 Participants	31.3 kg/m2 STANDARD_DEVIATION 7.1 • n=7 Participants	31.6 kg/m2 STANDARD_DEVIATION 5.9 • n=5 Participants	28.6 kg/m2 STANDARD_DEVIATION 4.2 • n=4 Participants	32.2 kg/m2 STANDARD_DEVIATION 5.2 • n=21 Participants	30.4 kg/m2 STANDARD_DEVIATION 5.3 • n=10 Participants
Waist circumference	98.7 cm STANDARD_DEVIATION 16.2 • n=5 Participants	99.8 cm STANDARD_DEVIATION 16.4 • n=7 Participants	101.8 cm STANDARD_DEVIATION 14.1 • n=5 Participants	101.1 cm STANDARD_DEVIATION 13.1 • n=4 Participants	106.5 cm STANDARD_DEVIATION 12.5 • n=21 Participants	103.3 cm STANDARD_DEVIATION 13.2 • n=10 Participants

PRIMARY outcome

Timeframe: 11 weeks for open-label period; 13 weeks for double-blind period

Population: Adverse events for the 46 patients enrolled in the open-label period are reported in the first (open-label) study arm. Adverse events for the 42 patients (out of the 46 enrolled) who were subsequently randomized to the double-blind period are reported across the last four (randomized) study arms.

Outcome measures

Outcome measures
Measure	Zicronapine Open-label 10 mg Daily n=46 Participants Zicronapine open-label 10 mg daily: Encapsulated tablet ,10 mg, once daily, open-label	Zicronapine Basis Dose 10 mg Daily n=11 Participants Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind	Zicronapine Low Dose 20 mg Once Weekly n=10 Participants Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind	Zicronapine Med Dose 30 mg Once Weekly n=11 Participants Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind	Zicronapine High Dose 45 mg Once Weekly n=10 Participants Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
Number of Patients With Adverse Events as a Measure of Safety and Tolerability	12 participants	8 participants	4 participants	4 participants	9 participants

SECONDARY outcome

Timeframe: 8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period)

Population: All patients who were randomized to the double-blind study period, who took at least one dose of drug, and who had at least one valid PANSS assessment were included in the analysis.

The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 that indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. The PANSS total score was the sum of the rating scores for 7 positive subscale items, 7 negative subscale items, and 16 general psychopathology subscale items from the PANSS panel. PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome).

Outcome measures

Outcome measures
Measure	Zicronapine Open-label 10 mg Daily n=10 Participants Zicronapine open-label 10 mg daily: Encapsulated tablet ,10 mg, once daily, open-label	Zicronapine Basis Dose 10 mg Daily n=8 Participants Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind	Zicronapine Low Dose 20 mg Once Weekly n=7 Participants Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind	Zicronapine Med Dose 30 mg Once Weekly n=8 Participants Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind	Zicronapine High Dose 45 mg Once Weekly Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
Positive and Negative Syndrome Scale (PANSS) Total and Subscales Change From Baseline PANSS total	-8.0 units on a scale Standard Error 2.7	-8.7 units on a scale Standard Error 2.5	-10.6 units on a scale Standard Error 2.6	-12.2 units on a scale Standard Error 2.5	—
Positive and Negative Syndrome Scale (PANSS) Total and Subscales Change From Baseline PANSS Positive Symptoms	-1.5 units on a scale Standard Error 1.1	-0.8 units on a scale Standard Error 1.0	-1.8 units on a scale Standard Error 1.1	-2.6 units on a scale Standard Error 1.0	—
Positive and Negative Syndrome Scale (PANSS) Total and Subscales Change From Baseline PANSS Negative Symptoms	-2.9 units on a scale Standard Error 1.0	-2.8 units on a scale Standard Error 1.0	-2.0 units on a scale Standard Error 1.0	-3.1 units on a scale Standard Error 1.0	—
Positive and Negative Syndrome Scale (PANSS) Total and Subscales Change From Baseline PANSS General Psychopathology	-5.2 units on a scale Standard Error 1.2	-5.5 units on a scale Standard Error 1.2	-6.4 units on a scale Standard Error 1.3	-6.2 units on a scale Standard Error 1.2	—

SECONDARY outcome

Timeframe: 8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period)

Population: All patients who were randomized to the double-blind study period, who took at least one dose of drug, and who had at least one valid PANSS assessment were included in the full analysis set (FAS)

The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses their clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).

Outcome measures

Outcome measures
Measure	Zicronapine Open-label 10 mg Daily n=10 Participants Zicronapine open-label 10 mg daily: Encapsulated tablet ,10 mg, once daily, open-label	Zicronapine Basis Dose 10 mg Daily n=8 Participants Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind	Zicronapine Low Dose 20 mg Once Weekly n=7 Participants Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind	Zicronapine Med Dose 30 mg Once Weekly n=8 Participants Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind	Zicronapine High Dose 45 mg Once Weekly Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
Clinical Global Impression Severity Scale (CGI-S) Change From Baseline	-0.5 units on a scale Standard Error 0.2	-0.5 units on a scale Standard Error 0.2	-0.2 units on a scale Standard Error 0.2	-0.7 units on a scale Standard Error 0.2	—

SECONDARY outcome

Timeframe: 8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period)

The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment is made independent of whether the rater believes the improvement is drug-related or not.

Outcome measures

Outcome measures
Measure	Zicronapine Open-label 10 mg Daily n=10 Participants Zicronapine open-label 10 mg daily: Encapsulated tablet ,10 mg, once daily, open-label	Zicronapine Basis Dose 10 mg Daily n=8 Participants Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind	Zicronapine Low Dose 20 mg Once Weekly n=7 Participants Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind	Zicronapine Med Dose 30 mg Once Weekly n=8 Participants Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind	Zicronapine High Dose 45 mg Once Weekly Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
Clinical Global Impression Improvement Scale (CGI-I)	2.9 units on a scale Standard Deviation 0.6	3.4 units on a scale Standard Deviation 1.1	3.0 units on a scale Standard Deviation 0.6	2.9 units on a scale Standard Deviation 1.1	—

Adverse Events

Zicronapine Open-label 10 mg Daily

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Zicronapine Basis Dose 10 mg Daily

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Zicronapine Low Dose 20 mg Once Weekly

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Zicronapine Med Dose 30 mg Once Weekly

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Zicronapine High Dose 45 mg Once Weekly

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Zicronapine Open-label 10 mg Daily n=46 participants at risk Zicronapine open-label 10 mg daily: Encapsulated tablet ,10 mg, once daily, open-label	Zicronapine Basis Dose 10 mg Daily n=11 participants at risk Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind	Zicronapine Low Dose 20 mg Once Weekly n=10 participants at risk Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind	Zicronapine Med Dose 30 mg Once Weekly n=11 participants at risk Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind	Zicronapine High Dose 45 mg Once Weekly n=10 participants at risk Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
Psychiatric disorders Schizophrenia	0.00% 0/46 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	9.1% 1/11 • Number of events 1 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	10.0% 1/10 • Number of events 1 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/46 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	10.0% 1/10 • Number of events 1 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.

Other adverse events

Other adverse events
Measure	Zicronapine Open-label 10 mg Daily n=46 participants at risk Zicronapine open-label 10 mg daily: Encapsulated tablet ,10 mg, once daily, open-label	Zicronapine Basis Dose 10 mg Daily n=11 participants at risk Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind	Zicronapine Low Dose 20 mg Once Weekly n=10 participants at risk Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind	Zicronapine Med Dose 30 mg Once Weekly n=11 participants at risk Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind	Zicronapine High Dose 45 mg Once Weekly n=10 participants at risk Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
Cardiac disorders Ventricular Tachycardia	0.00% 0/46 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	9.1% 1/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.
Gastrointestinal disorders Abdominal Discomfort	0.00% 0/46 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	9.1% 1/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	9.1% 1/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/46 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	9.1% 1/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.
Gastrointestinal disorders Dry Mouth	2.2% 1/46 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	9.1% 1/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.
Gastrointestinal disorders Dyspepsia	0.00% 0/46 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	10.0% 1/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.
General disorders Non-Cardiac Chest Pain	0.00% 0/46 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	10.0% 1/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.
General disorders Pain	0.00% 0/46 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	9.1% 1/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.
Infections and infestations Nasopharyngitis	2.2% 1/46 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	9.1% 1/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.
Infections and infestations Urinary Tract Infection	0.00% 0/46 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	10.0% 1/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.
Injury, poisoning and procedural complications Accidental Overdose	2.2% 1/46 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	20.0% 2/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.
Injury, poisoning and procedural complications Limb Injury	0.00% 0/46 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	9.1% 1/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.
Injury, poisoning and procedural complications Road Traffic Accident	0.00% 0/46 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	9.1% 1/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.
Investigations Alanine Aminotransferase Increased	0.00% 0/46 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	10.0% 1/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.
Investigations Aspartate Aminotransferase Increased	0.00% 0/46 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	10.0% 1/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.
Investigations Weight Decreased	0.00% 0/46 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	10.0% 1/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.
Investigations Weight Increased	0.00% 0/46 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	18.2% 2/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	10.0% 1/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	9.1% 1/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	20.0% 2/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/46 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	9.1% 1/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/46 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	10.0% 1/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/46 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	10.0% 1/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.
Musculoskeletal and connective tissue disorders Musculoskeletal Stiffness	0.00% 0/46 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	10.0% 1/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.
Musculoskeletal and connective tissue disorders Rheumatoid Arthritis	0.00% 0/46 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	9.1% 1/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.
Musculoskeletal and connective tissue disorders Trismus	0.00% 0/46 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	10.0% 1/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.
Nervous system disorders Dizziness	2.2% 1/46 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	10.0% 1/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.
Nervous system disorders Headache	0.00% 0/46 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	9.1% 1/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	10.0% 1/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.
Nervous system disorders Sedation	4.3% 2/46 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	9.1% 1/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.
Nervous system disorders Tardive Dyskinesia	0.00% 0/46 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	10.0% 1/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.
Psychiatric disorders Drug Abuse	0.00% 0/46 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	10.0% 1/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.
Psychiatric disorders Insomnia	2.2% 1/46 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	9.1% 1/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	20.0% 2/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	10.0% 1/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.
Psychiatric disorders Libido Decreased	0.00% 0/46 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	9.1% 1/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.
Psychiatric disorders Psychotic Disorder	2.2% 1/46 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	10.0% 1/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	9.1% 1/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.
Psychiatric disorders Schizophrenia	0.00% 0/46 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	9.1% 1/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.
Skin and subcutaneous tissue disorders Pruritus Generalised	0.00% 0/46 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	9.1% 1/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.
Social circumstances Treatment Noncompliance	0.00% 0/46 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	0.00% 0/11 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.	10.0% 1/10 • Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total) Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.

Additional Information

Study director

H. Lundbeck A/S

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place