Trial Outcomes & Findings for Efficacy and Safety of Calcipotriol Plus Hydrocortisone Ointment in Psoriasis Vulgaris on the Face and Skin Folds (NCT NCT00691002)

Last Updated: 2025-03-10

Results Overview

The (sub) investigator made an assessment of the disease severity of the face using the 6-category scale below. Clear, Almost clear, Mild, Moderate, Severe, Very severe The assessment was made considering the condition of psoriasis vulgaris of the face at the time of the evaluation, not in relation to the condition at a previous visit. For subjects with a baseline (Visit 1) severity of moderate or worse - "controlled disease" of the face was defined as clear or almost clear according to the IGA of disease severity of the face. For subjects with a baseline (Visit 1) severity of mild - "controlled disease" of the face was defined as clear according to the IGA of disease severity of the face.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1245 participants

Primary outcome timeframe

At Week 8 (end of treatment for double-blind phase)

Results posted on

2025-03-10

Participant Flow

A total of 1245 subjects were enrolled (informed consent signed and CRF started). Five subjects left the study during washout (2 screening failures, 2 lost to follow-up and 1 unacceptable adverse event). One subject attended Visit 1 but was not randomized (voluntary withdrawal). Therefore, 1239 of the enrolled subjects were randomized in the study.

The Randomized double-blind phase of the study lasted up to 8 weeks, and was followed by a 52-week Open-label period in which participants had the opportunity to receive Calcipotriol 25 mcg/g plus 10 mg/g Hydrocortisone ointment.

Participant milestones

Participant milestones
Measure	LEO 80190 Once daily application Calcipotriol 25 mcg/g plus 10 mg/g hydrocortisone ointment (LEO 80190)	Calcipotriol Once daily application Calcipotriol 25 mcg/g in the ointment vehicle	Hydrocortisone Once daily application Hydrocortisone 10 mg/g in the ointment vehicle	LEO 80190 Vehicle Once daily application Ointment Vehicle
8-week, Double-blind, 4-arm STARTED	353	342	363	181
8-week, Double-blind, 4-arm COMPLETED	325	308	340	169
8-week, Double-blind, 4-arm NOT COMPLETED	28	34	23	12
52-week, Open-label, Single Arm STARTED	454	0	0	0
52-week, Open-label, Single Arm COMPLETED	403	0	0	0
52-week, Open-label, Single Arm NOT COMPLETED	51	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of Calcipotriol Plus Hydrocortisone Ointment in Psoriasis Vulgaris on the Face and Skin Folds

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LEO 80190 n=353 Participants Once daily application Calcipotriol 25 mcg/g plus 10 mg/g hydrocortisone ointment (LEO 80190)	Calcipotriol n=342 Participants Once daily application Calcipotriol 25 mcg/g in the ointment vehicle	Hydrocortisone n=363 Participants Once daily application Hydrocortisone 10 mg/g in the ointment vehicle	LEO 80190 Vehicle n=181 Participants Once daily application Ointment Vehicle	Total n=1239 Participants Total of all reporting groups
Age, Continuous	42.8 years STANDARD_DEVIATION 15.3 • n=5 Participants	44.8 years STANDARD_DEVIATION 15.1 • n=7 Participants	43.0 years STANDARD_DEVIATION 14.1 • n=5 Participants	44.6 years STANDARD_DEVIATION 15.1 • n=4 Participants	43.6 years STANDARD_DEVIATION 14.9 • n=21 Participants
Sex: Female, Male Female	155 Participants n=5 Participants	139 Participants n=7 Participants	147 Participants n=5 Participants	76 Participants n=4 Participants	517 Participants n=21 Participants
Sex: Female, Male Male	198 Participants n=5 Participants	203 Participants n=7 Participants	216 Participants n=5 Participants	105 Participants n=4 Participants	722 Participants n=21 Participants
Region of Enrollment Belgium	4 participants n=5 Participants	6 participants n=7 Participants	5 participants n=5 Participants	2 participants n=4 Participants	17 participants n=21 Participants
Region of Enrollment Croatia	15 participants n=5 Participants	13 participants n=7 Participants	16 participants n=5 Participants	7 participants n=4 Participants	51 participants n=21 Participants
Region of Enrollment Czechia	29 participants n=5 Participants	22 participants n=7 Participants	24 participants n=5 Participants	15 participants n=4 Participants	90 participants n=21 Participants
Region of Enrollment Germany	99 participants n=5 Participants	95 participants n=7 Participants	96 participants n=5 Participants	55 participants n=4 Participants	345 participants n=21 Participants
Region of Enrollment Hungary	58 participants n=5 Participants	59 participants n=7 Participants	64 participants n=5 Participants	35 participants n=4 Participants	216 participants n=21 Participants
Region of Enrollment Latvia	23 participants n=5 Participants	20 participants n=7 Participants	24 participants n=5 Participants	10 participants n=4 Participants	77 participants n=21 Participants
Region of Enrollment Macedonia	7 participants n=5 Participants	8 participants n=7 Participants	8 participants n=5 Participants	3 participants n=4 Participants	26 participants n=21 Participants
Region of Enrollment Netherlands	4 participants n=5 Participants	6 participants n=7 Participants	5 participants n=5 Participants	1 participants n=4 Participants	16 participants n=21 Participants
Region of Enrollment Poland	79 participants n=5 Participants	76 participants n=7 Participants	80 participants n=5 Participants	37 participants n=4 Participants	272 participants n=21 Participants
Region of Enrollment Serbia	34 participants n=5 Participants	36 participants n=7 Participants	40 participants n=5 Participants	16 participants n=4 Participants	126 participants n=21 Participants
Region of Enrollment Slovenia	1 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	3 participants n=21 Participants

PRIMARY outcome

Timeframe: At Week 8 (end of treatment for double-blind phase)

Outcome measures

Outcome measures
Measure	LEO 80190 n=353 Participants Once daily application Calcipotriol plus hydrocortisone (LEO 80190)	Calcipotriol n=341 Participants Once daily application Calcipotriol 25 mcg/g in the ointment vehicle	Hydrocortisone n=363 Participants Once daily application Hydrocortisone 10 mg/g in the ointment vehicle	LEO 80190 Vehicle n=180 Participants Once daily application Ointment Vehicle
Participants With "Controlled Disease" According to the Investigator's Global Assessment(IGA) of Disease Severity of the Face at Week 8 (Visit 6) in the Double-blind Phase	158 Participants	135 Participants	115 Participants	41 Participants

SECONDARY outcome

Timeframe: At Week 4

The assessment of the disease severity of the face was made using the 6-category scale below. Clear Almost clear Mild Moderate Severe Very severe The assessment was made considering the condition of psoriasis vulgaris of the face at the time of the evaluation, not in relation to the condition at a previous visit. For subjects with a baseline severity of moderate or worse - "controlled disease" of the face was defined as clear or almost clear according to the IGA of disease severity of the face. For subjects with a baseline severity of mild - "controlled disease" of the face was defined as clear according to the IGA of disease severity of the face.

Outcome measures

Outcome measures
Measure	LEO 80190 n=353 Participants Once daily application Calcipotriol plus hydrocortisone (LEO 80190)	Calcipotriol n=341 Participants Once daily application Calcipotriol 25 mcg/g in the ointment vehicle	Hydrocortisone n=363 Participants Once daily application Hydrocortisone 10 mg/g in the ointment vehicle	LEO 80190 Vehicle n=180 Participants Once daily application Ointment Vehicle
Participants With "Controlled Disease" According to the IGA of Disease Severity of the Face at Week 4 (Visit 4) in the Double-blind Phase	101 Participants	66 Participants	61 Participants	14 Participants

SECONDARY outcome

Timeframe: At Week 8 (end of treatment for double-blind phase)

"Success" was defined as a TSS score of 0 or 1. For each clinical sign, a single score, reflecting the average severity of all psoriatic lesions on the face was determined according to the scale below: Redness 0 = none (no erythema) 1 = mild (faint erythema, pink to very light red) 2 = moderate (definite light red erythema) 3 = severe (dark red erythema) 4 = very severe (very dark red erythema) Thickness 0 = none (no plaque elevation) 1 = mild (slight, barely perceptible elevation) 2 = moderate (definite elevation but not thick) 3 = severe (definite elevation, thick plaque with sharp edge) 4 = very severe (very thick plaque with sharp edge) Scaliness 0 = none (no scaling) 1 = mild (sparse, fine-scale lesions, only partially covered) 2 = moderate (coarser scales, most of lesions covered) 3 = severe (entire lesion covered with coarse scales) 4 = very severe (very thick coarse scales, possibly fissured) The sum of the three scores constituted a TSS ranging from 0 to 12

Outcome measures

Outcome measures
Measure	LEO 80190 n=353 Participants Once daily application Calcipotriol plus hydrocortisone (LEO 80190)	Calcipotriol n=341 Participants Once daily application Calcipotriol 25 mcg/g in the ointment vehicle	Hydrocortisone n=363 Participants Once daily application Hydrocortisone 10 mg/g in the ointment vehicle	LEO 80190 Vehicle n=180 Participants Once daily application Ointment Vehicle
Participants With "Success" According to Total Sign Score (TSS) of the Face at Week 8 (Visit 6) in the Double-blind Phase	171 Participants	136 Participants	131 Participants	42 Participants

SECONDARY outcome

Timeframe: At Week 8 (end of treatment for double-blind phase)

The (sub)investigator made an assessment of the disease severity of the intertriginous areas using the 6-category scale below. Clear, Almost clear, Mild, Moderate, Severe, Very severe The assessment was made considering the condition of psoriasis vulgaris of the intertrigi-nous areas at the time of the evaluation, not in relation to the condition at a previous visit. For subjects with a baseline severity of moderate or worse - "controlled disease" of the intertriginous areas was defined as clear or almost clear according to the IGA of disease severity of the intertriginous areas. For subjects with a baseline severity of mild - "controlled disease" of the intertriginous areas was defined as clear according to the IGA of disease severity of the intertriginous areas.

Outcome measures

Outcome measures
Measure	LEO 80190 n=171 Participants Once daily application Calcipotriol plus hydrocortisone (LEO 80190)	Calcipotriol n=173 Participants Once daily application Calcipotriol 25 mcg/g in the ointment vehicle	Hydrocortisone n=182 Participants Once daily application Hydrocortisone 10 mg/g in the ointment vehicle	LEO 80190 Vehicle n=89 Participants Once daily application Ointment Vehicle
Participants With "Controlled Disease" According to the IGA of Disease Severity of the Intertriginous Areas at Week 8 (Visit 6) in the Double-blind Phase	80 Participants	55 Participants	48 Participants	14 Participants

SECONDARY outcome

Timeframe: At Week 8 (end of treatment for double-blind phase)

The severity of the subject's psoriasis vulgaris on the intertriginous areas was evaluated in terms of the three clinical signs: redness, thickness and scaliness. All the defined intertriginous areas were rated separately using the same scale as for the investigator's assessment of clinical signs (redness, thickness and scaliness) of the face. For each clinical sign, a single score, reflecting the average severity of all psoriatic lesions on the face was determined according to the scale below: Redness 0 = none 1. = mild 2. = moderate 3. = severe 4. = very severe Thickness 0 = none 1. = mild 2. = moderate 3. = severe 4. = very severe Scaliness 0 = none 1. = mild 2. = moderate 3. = severe 4. = very severe A mean score was calculated for each sign (redness, thickness and scaliness) based on scores of all the defined intertriginous areas with psoriasis at baseline and the sum of these mean scores constituted the TSS. "Success" was defined as a TSS score of 0 or 1.

Outcome measures

Outcome measures
Measure	LEO 80190 n=171 Participants Once daily application Calcipotriol plus hydrocortisone (LEO 80190)	Calcipotriol n=173 Participants Once daily application Calcipotriol 25 mcg/g in the ointment vehicle	Hydrocortisone n=182 Participants Once daily application Hydrocortisone 10 mg/g in the ointment vehicle	LEO 80190 Vehicle n=89 Participants Once daily application Ointment Vehicle
Participants With "Success" According to Total Sign Score of the Intertriginous Areas at Week 8 (Visit 6) in the Double-blind Phase	82 Participants	81 Participants	59 Participants	15 Participants

Adverse Events

LEO 80190

Serious events: 5 serious events

Other events: 91 other events

Deaths: 0 deaths

Calcipotriol

Serious events: 5 serious events

Other events: 100 other events

Deaths: 0 deaths

Hydrocortisone

Serious events: 4 serious events

Other events: 70 other events

Deaths: 0 deaths

LEO 80190 Vehicle

Serious events: 0 serious events

Other events: 47 other events

Deaths: 0 deaths

Open-label Phase

Serious events: 24 serious events

Other events: 266 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	LEO 80190 n=351 participants at risk Once daily application Calcipotriol plus hydrocortisone (LEO 80190)	Calcipotriol n=341 participants at risk Once daily application Calcipotriol 25 mcg/g in the ointment vehicle	Hydrocortisone n=362 participants at risk Once daily application Hydrocortisone 10 mg/g in the ointment vehicle	LEO 80190 Vehicle n=181 participants at risk Once daily application Ointment Vehicle	Open-label Phase n=453 participants at risk LEO 80190 ointment : calcipotriol 25 mcg/g plus 10 mg/g hydrocortisone ointment
Cardiac disorders Atrial fibrillation	0.00% 0/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.29% 1/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Cardiac disorders Myocardial infarction	0.28% 1/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.22% 1/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Ear and labyrinth disorders Tinnitus	0.28% 1/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
General disorders Chest pain	0.00% 0/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.28% 1/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Infections and infestations Pneumonia	0.00% 0/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.29% 1/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.22% 1/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Injury, poisoning and procedural complications Deafness traumatic	0.28% 1/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Injury, poisoning and procedural complications Upper limb fracture	0.28% 1/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.29% 1/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign bone neoplasm	0.00% 0/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.29% 1/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.22% 1/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal neoplasm	0.00% 0/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.29% 1/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Psychiatric disorders Depression	0.00% 0/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.28% 1/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Skin and subcutaneous tissue disorders Psoriasis	0.57% 2/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.55% 2/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.66% 3/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Cardiac disorders Cardiac failure congestive	0.00% 0/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.22% 1/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Ear and labyrinth disorders Vertigo	0.00% 0/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.22% 1/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Gastrointestinal disorders Diverticulitis	0.00% 0/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.22% 1/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Gastrointestinal disorders Nausea	0.00% 0/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.22% 1/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Infections and infestations Erysipelas	0.00% 0/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.44% 2/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Infections and infestations Gastroenteritis	0.00% 0/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.22% 1/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Injury, poisoning and procedural complications Cervical vertebra injury	0.00% 0/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.22% 1/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.44% 2/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Injury, poisoning and procedural complications Concussion	0.00% 0/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.22% 1/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Injury, poisoning and procedural complications Contusion	0.00% 0/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.44% 2/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Injury, poisoning and procedural complications Excoriation	0.00% 0/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.22% 1/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma stage 0	0.00% 0/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.22% 1/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.00% 0/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.22% 1/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.22% 1/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Nervous system disorders Cerebrovascular accident	0.00% 0/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.22% 1/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Pregnancy, puerperium and perinatal conditions Pregnancy	0.00% 0/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.44% 2/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Psychiatric disorders Panic disorder	0.00% 0/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.22% 1/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Reproductive system and breast disorders Postmenopausal haemorrhage	0.00% 0/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.22% 1/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Surgical and medical procedures Knee operation	0.00% 0/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.22% 1/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Vascular disorders Hypertensive crisis	0.00% 0/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.22% 1/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.

Other adverse events

Other adverse events
Measure	LEO 80190 n=351 participants at risk Once daily application Calcipotriol plus hydrocortisone (LEO 80190)	Calcipotriol n=341 participants at risk Once daily application Calcipotriol 25 mcg/g in the ointment vehicle	Hydrocortisone n=362 participants at risk Once daily application Hydrocortisone 10 mg/g in the ointment vehicle	LEO 80190 Vehicle n=181 participants at risk Once daily application Ointment Vehicle	Open-label Phase n=453 participants at risk LEO 80190 ointment : calcipotriol 25 mcg/g plus 10 mg/g hydrocortisone ointment
Gastrointestinal disorders Diarrhoea	1.1% 4/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	1.8% 6/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	2.0% 9/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Gastrointestinal disorders Toothache	1.1% 4/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.29% 1/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.28% 1/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	1.1% 5/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
General disorders Application site pruritus	0.57% 2/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	1.1% 2/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
General disorders Pyrexia	1.1% 4/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.59% 2/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.83% 3/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	1.1% 2/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	2.0% 9/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Infections and infestations Herpes simplex	1.1% 4/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.28% 1/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Infections and infestations Influenza	0.85% 3/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.59% 2/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.55% 2/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	1.1% 2/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	2.2% 10/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Infections and infestations Nasopharyngitis	2.3% 8/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	1.5% 5/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	3.3% 12/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	6.1% 11/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	12.1% 55/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Nervous system disorders Burning sensation	1.4% 5/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	3.5% 12/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.28% 1/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	2.2% 4/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Nervous system disorders Headache	3.1% 11/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	1.8% 6/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	2.2% 8/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	1.1% 2/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	3.8% 17/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Rhinitis	1.1% 4/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.29% 1/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	1.1% 4/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	2.9% 13/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Skin and subcutaneous tissue disorders Erythema	2.0% 7/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	7.0% 24/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	1.9% 7/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	3.9% 7/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	2.9% 13/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Skin and subcutaneous tissue disorders Pruritus	2.0% 7/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	4.1% 14/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.83% 3/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	2.8% 5/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	1.8% 8/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Skin and subcutaneous tissue disorders Psoriasis	7.4% 26/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	6.7% 23/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	7.5% 27/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	6.6% 12/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	25.2% 114/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Skin and subcutaneous tissue disorders Skin irritation	0.57% 2/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	1.2% 4/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.28% 1/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Infections and infestations Bronchitis	0.00% 0/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	1.3% 6/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Infections and infestations Cystitis acute	0.00% 0/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	1.1% 5/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Infections and infestations Respiratory tract infection viral	0.00% 0/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	2.0% 9/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Infections and infestations Upper respiratory tract infection	0.00% 0/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	1.3% 6/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Infections and infestations Viral infection	0.00% 0/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	1.1% 5/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	2.6% 12/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	1.8% 8/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	2.2% 10/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	1.8% 8/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Vascular disorders Hypertension	0.00% 0/351 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/341 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/362 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	0.00% 0/181 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.	1.5% 7/453 • Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2) The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.

Additional Information

Clinical Trial Disclosure Manager

LEO Pharma A/S

Phone: +45 4494 5888

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Company acknowledges the investigators' right to publish the entire results of the study, irrespective of outcome. The Company retains the right to have any publication submitted to the Company for review at least 30 days prior to the same paper being submit-ted for publication or presentation. Investigators must undertake not to submit any part of their individual data for publication without the prior consent of LEO.
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