Trial Outcomes & Findings for TRUST Study: Raptiva ® in Hand & Foot Psoriasis (NCT NCT00739882)

NCT ID: NCT00739882

Last Updated: 2014-02-27

Results Overview

The proportion of subjects achieving a PGA - H\&F rating of clear, almost clear, or mild at Week 12: Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet; Mild - Light pink erythema with minimal scaling and with or without pustules on the hands and/or feet

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 76 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2014-02-27

Participant Flow

First subject's first visit: 08 April 2008, last subject's last visit: 15 June 2009. Seventy six subjects entered the study, 46 completed the double-blind period and 31 of these then entered the open-label period. The remaining 15 entered an observational follow-up.

During the screening period, approximately 200 subjects were to be screened for trial eligibility within 14 days before Day 1. A total of 100 subjects had been screened at the time the trial was terminated, of whom 76 subjects were enrolled in the trial.

Participant milestones

Measure	Efalizumab Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.	Placebo Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)
Double-blind Period STARTED	51	25
Double-blind Period COMPLETED	32	14
Double-blind Period NOT COMPLETED	19	11
Open-label Period STARTED	17	14
Open-label Period COMPLETED	7	9
Open-label Period NOT COMPLETED	10	5

Reasons for withdrawal

Measure	Efalizumab Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.	Placebo Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)
Double-blind Period Adverse Event	1	2
Double-blind Period Protocol Violation	1	0
Double-blind Period Lack of Efficacy	1	1
Double-blind Period Other	16	8
Open-label Period Adverse Event	1	0
Open-label Period Other	9	5

Baseline Characteristics

TRUST Study: Raptiva ® in Hand & Foot Psoriasis

Baseline characteristics by cohort

Measure	Efalizumab n=51 Participants Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.	Placebo n=25 Participants Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)	Total n=76 Participants Total of all reporting groups
Age, Customized 18-40 years	16 participants n=5 Participants	4 participants n=7 Participants	20 participants n=5 Participants
Age, Customized 41-64 years	29 participants n=5 Participants	17 participants n=7 Participants	46 participants n=5 Participants
Age, Customized >64 years	6 participants n=5 Participants	4 participants n=7 Participants	10 participants n=5 Participants
Age, Continuous	49.0 years STANDARD_DEVIATION 13.3 • n=5 Participants	51.7 years STANDARD_DEVIATION 12.9 • n=7 Participants	49.9 years STANDARD_DEVIATION 13.1 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	10 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	15 Participants n=7 Participants	45 Participants n=5 Participants
Region of Enrollment Austria	7 participants n=5 Participants	4 participants n=7 Participants	11 participants n=5 Participants
Region of Enrollment Belgium	4 participants n=5 Participants	0 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment France	8 participants n=5 Participants	5 participants n=7 Participants	13 participants n=5 Participants
Region of Enrollment Germany	14 participants n=5 Participants	4 participants n=7 Participants	18 participants n=5 Participants
Region of Enrollment Italy	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment Netherlands	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment Spain	7 participants n=5 Participants	4 participants n=7 Participants	11 participants n=5 Participants
Region of Enrollment Turkey	9 participants n=5 Participants	4 participants n=7 Participants	13 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Due to the termination of the trial, analysis of efficacy-related endpoints was not performed

The proportion of subjects achieving a PGA - H&F rating of clear, almost clear, or mild at Week 12:

Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet; Mild - Light pink erythema with minimal scaling and with or without pustules on the hands and/or feet

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Due to the termination of the trial, analysis of efficacy-related endpoints was not performed

The proportion of participants achieving a PGA - H&F rating of clear, or almost clear, at Week 12:

Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Population: Due to the termination of the trial, analysis of efficacy-related endpoints was not performed

The proportion of participants achieving a PGA - H&F rating of clear, almost clear, or mild at Week 24:

Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet; Mild - Light pink erythema with minimal scaling and with or without pustules on the hands and/or feet

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Population: Due to the termination of the trial, analysis of efficacy-related endpoints was not performed

The proportion of participants achieving a PGA - H&F rating of clear, or almost clear, at Week 24:

Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet; Mild - Light pink erythema with minimal scaling and with or without pustules on the hands and/or feet

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Due to the termination of the trial, analysis of efficacy-related endpoints was not performed

The proportion of participants achieving a PGA rating of good, excellent, or cleared at Week 12.

Cleared = 100% improvement; Excellent = 75-99% improvement; Good = 50-74% improvement

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Due to the termination of the trial, analysis of efficacy-related endpoints was not performed

The proportion of participants achieving a PGA rating of excellent, or cleared at Week 12.

Cleared = 100% improvement; Excellent = 75-99% improvement

Outcome measures

Outcome data not reported

Adverse Events

Efalizumab - Double-blind Period

Serious events: 1 serious events

Other events: 35 other events

Deaths: 0 deaths

Placebo - Double-blind Period

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Efalizumab - Open-label Period

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo - Open-label Period

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Efalizumab - Double-blind Period n=51 participants at risk	Placebo - Double-blind Period n=25 participants at risk	Efalizumab - Open-label Period n=17 participants at risk	Placebo - Open-label Period n=14 participants at risk
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	7.1% 1/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Infections and infestations Meningitis aseptic	0.00% 0/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	4.0% 1/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Skin and subcutaneous tissue disorders Psoriasis	2.0% 1/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Surgical and medical procedures Tendon operation	0.00% 0/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	7.1% 1/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.

Other adverse events

Measure	Efalizumab - Double-blind Period n=51 participants at risk	Placebo - Double-blind Period n=25 participants at risk	Efalizumab - Open-label Period n=17 participants at risk	Placebo - Open-label Period n=14 participants at risk
Gastrointestinal disorders Abdominal pain	0.00% 0/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	8.0% 2/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Infections and infestations Acute tonsillitis	2.0% 1/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Investigations Alanine aminotransferase increased	2.0% 1/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Psychiatric disorders Anxiety	0.00% 0/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	8.0% 2/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Musculoskeletal and connective tissue disorders Arthralgia	3.9% 2/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Investigations Aspartate aminotransferase increased	2.0% 1/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
General disorders Asthenia	3.9% 2/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	7.1% 1/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Investigations Blood glucose increased	0.00% 0/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	7.1% 1/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Musculoskeletal and connective tissue disorders Bone pain	2.0% 1/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Infections and infestations Bronchitis	2.0% 1/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Metabolism and nutrition disorders Cachexia	2.0% 1/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Nervous system disorders Carotid arteriosclerosis	2.0% 1/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Infections and infestations Cellulitis	2.0% 1/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Gastrointestinal disorders Cheilitis	0.00% 0/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	4.0% 1/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
General disorders Chest pain	2.0% 1/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
General disorders Chills	3.9% 2/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	4.0% 1/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	2.0% 1/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Gastrointestinal disorders Colitis ulcerative	2.0% 1/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Eye disorders Conjunctival hyperaemia	2.0% 1/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Eye disorders Conjunctivitis	2.0% 1/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Gastrointestinal disorders Constipation	0.00% 0/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	5.9% 1/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Respiratory, thoracic and mediastinal disorders Cough	2.0% 1/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Psychiatric disorders Depression	0.00% 0/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	4.0% 1/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Skin and subcutaneous tissue disorders Dermatitis	3.9% 2/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	4.0% 1/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Gastrointestinal disorders Diarrhoea	2.0% 1/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	4.0% 1/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Skin and subcutaneous tissue disorders Dry skin	2.0% 1/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Gastrointestinal disorders Dyspepsia	0.00% 0/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	4.0% 1/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Renal and urinary disorders Dysuria	2.0% 1/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Skin and subcutaneous tissue disorders Eczema	3.9% 2/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Reproductive system and breast disorders Endometrial hyperplasia	0.00% 0/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	7.1% 1/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.0% 1/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	5.9% 1/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Eye disorders Eye pain	0.00% 0/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	7.1% 1/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Eye disorders Eye swelling	2.0% 1/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Eye disorders Eyelid oedema	0.00% 0/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	5.9% 1/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
General disorders Fatigue	9.8% 5/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	14.3% 2/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Investigations Gamma-glutamyltransferase increased	2.0% 1/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Infections and infestations Gastroenteritis	2.0% 1/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	7.1% 1/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Gastrointestinal disorders Gastrointestinal disorder	2.0% 1/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Infections and infestations Gastrointestinal infection	3.9% 2/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Skin and subcutaneous tissue disorders Generalised erythema	0.00% 0/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	5.9% 1/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Nervous system disorders Headache	19.6% 10/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	4.0% 1/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	5.9% 1/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	14.3% 2/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	4.0% 1/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Vascular disorders Hypertension	2.0% 1/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Infections and infestations Impetigo	2.0% 1/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Infections and infestations Influenza	3.9% 2/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
General disorders Influenza like illness	9.8% 5/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	4.0% 1/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	5.9% 1/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	7.1% 1/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Psychiatric disorders Insomnia	0.00% 0/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	4.0% 1/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	7.1% 1/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Injury, poisoning and procedural complications Joint sprain	2.0% 1/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Blood and lymphatic system disorders Leukocytosis	11.8% 6/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	4.0% 1/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	5.9% 1/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Blood and lymphatic system disorders Lymphocytosis	2.0% 1/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Infections and infestations Meningitis aseptic	0.00% 0/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	4.0% 1/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Musculoskeletal and connective tissue disorders Myalgia	2.0% 1/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	4.0% 1/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Infections and infestations Nasopharyngitis	3.9% 2/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	12.0% 3/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	14.3% 2/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Gastrointestinal disorders Nausea	0.00% 0/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	4.0% 1/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Musculoskeletal and connective tissue disorders Neck pain	2.0% 1/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	7.1% 1/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
General disorders Non-cardiac chest pain	2.0% 1/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Eye disorders Ocular hyperaemia	2.0% 1/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
General disorders Oedema peripheral	2.0% 1/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	8.0% 2/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Gastrointestinal disorders Oral mucosa erosion	2.0% 1/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
General disorders Pain	0.00% 0/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	4.0% 1/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Nervous system disorders Paraesthesia	2.0% 1/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	4.0% 1/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	2.0% 1/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	12.0% 3/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Skin and subcutaneous tissue disorders Psoriasis	3.9% 2/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	4.0% 1/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	5.9% 1/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	7.1% 1/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
General disorders Pyrexia	2.0% 1/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Skin and subcutaneous tissue disorders Rash papular	3.9% 2/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Infections and infestations Rhinitis	5.9% 3/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Nervous system disorders Sciatica	2.0% 1/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Reproductive system and breast disorders Sinus congestion	2.0% 1/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Gastrointestinal disorders Stomatitis	0.00% 0/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	5.9% 1/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Surgical and medical procedures Tendon operation	0.00% 0/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	4.0% 1/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	7.1% 1/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Infections and infestations Tonsillitis	2.0% 1/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Investigations Transaminases increased	0.00% 0/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	4.0% 1/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Infections and infestations Upper respiratory tract infection	3.9% 2/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	5.9% 1/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Infections and infestations Urinary tract infection	3.9% 2/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	5.9% 1/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	7.1% 1/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
Ear and labyrinth disorders Vertigo	2.0% 1/51 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	4.0% 1/25 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/17 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.	0.00% 0/14 • Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.

Additional Information

Medical Responsible

Merck Serono, a division of Merck KGaA, Darmstadt, Germany

Phone: +49 6151 72 5200

Email: service@merckgroup.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER