Trial Outcomes & Findings for Safety and Efficacy of Escalating Doses of LEO 43204 Applied Once Daily for Two Consecutive Days on Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis (NCT NCT02120456)

NCT ID: NCT02120456

Last Updated: 2025-03-06

Results Overview

The number participants experiencing a DLT was used to identify the maximum tolerated dose(MTD) levels of LEO 43204 after once daily treatment for 2 consecutive days.The MTD was defined as the highest dose level at which less than 4 out of 12 participants experienced a DLT. A DLT was defined as one or more of the following three LSRs: * Crusting Grade 4 * Erosion/Ulceration Grade 4 * Vesiculation/Pustulation Grade 4 or two or more of the following five LSRs: * Crusting Grade 3 * Swelling Grade 4 * Erosion/Ulceration Grade 3 * Vesiculation/Pustulation Grade 3 or other clinically relevant signs or symptoms observed, which the Investigator judged to be counted as a DLT. The LSRs consists of the following 6 categories: Erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration. Each individual LSR category was given a numeric grade of severity from 0-4. Grade 0 being no presence and Grade 4 being the highest grade of severity.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 224 participants
• Primary outcome timeframe: From Day 1 up to and including Day 8
• Results posted on: 2025-03-06

Participant Flow

Participant milestones

Measure	Part 1: LEO 43204 Gel 0.018% Once daily treatment for two consecutive days with LEO 43204 gel 0.018% on sun exposed area of 250 cm2 on the arm between wrist and shoulder.	Part 1: LEO 43204 Gel 0.025% Once daily treatment for two consecutive days with LEO 43204 gel 0.025% on sun exposed area of 250 cm2 on the arm between wrist and shoulder.	Part 1: LEO 43204 Gel 0.037% Once daily treatment for two consecutive days with LEO 43204 gel 0.037% on sun exposed area of 250 cm2 on the arm between wrist and shoulder.	Part 1: LEO 43204 Gel 0.05% Once daily treatment for two consecutive days with LEO 43204 gel 0.05% on sun exposed area of 250 cm2 on the arm between wrist and shoulder.	Part 1: LEO 43204 Gel 0.075% Once daily treatment for two consecutive days with LEO 43204 gel 0.075% on sun exposed area of 250 cm2 on the arm between wrist and shoulder.	Part 1: LEO 43204 Gel 0.1% Once daily treatment for two consecutive days with LEO 43204 gel 0.1% on sun exposed area of 250 cm2 on the arm between wrist and shoulder.	Part 2: LEO 43204 Vehicle Gel Once daily treatment for two consecutive days with LEO 43204 vehicle gel on sun exposed area of 250 cm2 on the extremities or trunk (except chest).	Part 2: LEO 43204 Gel 0.075% Once daily treatment for two consecutive days with LEO 43204 gel 0.075% on sun exposed area of 250 cm2 on the extremities or trunk (except chest).	Part 2: LEO 43204 Gel 0.1% Once daily treatment for two consecutive days with LEO 43204 gel 0.1% on sun exposed area of 250 cm2 on the extremities or trunk (except chest).
Part 1 Open-label, Dose-escalation Phase STARTED	12	12	12	12	12	9	0	0	0
Part 1 Open-label, Dose-escalation Phase COMPLETED	12	12	12	12	12	9	0	0	0
Part 1 Open-label, Dose-escalation Phase NOT COMPLETED	0	0	0	0	0	0	0	0	0
Part 2 Double-blind Phase STARTED	0	0	0	0	0	0	32	60	63
Part 2 Double-blind Phase COMPLETED	0	0	0	0	0	0	30	60	62
Part 2 Double-blind Phase NOT COMPLETED	0	0	0	0	0	0	2	0	1

Reasons for withdrawal

Measure	Part 1: LEO 43204 Gel 0.018% Once daily treatment for two consecutive days with LEO 43204 gel 0.018% on sun exposed area of 250 cm2 on the arm between wrist and shoulder.	Part 1: LEO 43204 Gel 0.025% Once daily treatment for two consecutive days with LEO 43204 gel 0.025% on sun exposed area of 250 cm2 on the arm between wrist and shoulder.	Part 1: LEO 43204 Gel 0.037% Once daily treatment for two consecutive days with LEO 43204 gel 0.037% on sun exposed area of 250 cm2 on the arm between wrist and shoulder.	Part 1: LEO 43204 Gel 0.05% Once daily treatment for two consecutive days with LEO 43204 gel 0.05% on sun exposed area of 250 cm2 on the arm between wrist and shoulder.	Part 1: LEO 43204 Gel 0.075% Once daily treatment for two consecutive days with LEO 43204 gel 0.075% on sun exposed area of 250 cm2 on the arm between wrist and shoulder.	Part 1: LEO 43204 Gel 0.1% Once daily treatment for two consecutive days with LEO 43204 gel 0.1% on sun exposed area of 250 cm2 on the arm between wrist and shoulder.	Part 2: LEO 43204 Vehicle Gel Once daily treatment for two consecutive days with LEO 43204 vehicle gel on sun exposed area of 250 cm2 on the extremities or trunk (except chest).	Part 2: LEO 43204 Gel 0.075% Once daily treatment for two consecutive days with LEO 43204 gel 0.075% on sun exposed area of 250 cm2 on the extremities or trunk (except chest).	Part 2: LEO 43204 Gel 0.1% Once daily treatment for two consecutive days with LEO 43204 gel 0.1% on sun exposed area of 250 cm2 on the extremities or trunk (except chest).
Part 2 Double-blind Phase Lost to Follow-up	0	0	0	0	0	0	1	0	0
Part 2 Double-blind Phase Withdrawal of consent	0	0	0	0	0	0	1	0	0
Part 2 Double-blind Phase Unable to attend visit due to work	0	0	0	0	0	0	0	0	1

Baseline Characteristics

Safety and Efficacy of Escalating Doses of LEO 43204 Applied Once Daily for Two Consecutive Days on Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis

Baseline characteristics by cohort

Measure	Part 1: LEO 43204 Gel 0.025% n=12 Participants Once daily treatment for two consecutive days with LEO 43204 gel 0.025%	Part 1: LEO 43204 Gel 0.037% n=12 Participants Once daily treatment for two consecutive days with LEO 43204 gel 0.037%	Part 1: LEO 43204 Gel 0.05% n=12 Participants Once daily treatment for two consecutive days with LEO 43204 gel 0.05%	Part 1: LEO 43204 Gel 0.075% n=12 Participants Once daily treatment for two consecutive days with LEO 43204 gel 0.075%	Part 1: LEO 43204 Gel 0.1% n=9 Participants Once daily treatment for two consecutive days with LEO 43204 gel 0.1%	Part 2: LEO 43204 Vehicle Gel n=32 Participants Once daily treatment for two consecutive days LEO 43204 vehicle gel	Part 1: LEO 43204 Gel 0.018% n=12 Participants Once daily treatment for two consecutive days with LEO 43204 gel 0.018%	Part 2: LEO 43204 Gel 0.075% n=60 Participants Once daily treatment for two consecutive days LEO 43204 gel 0.075%	Part 2: LEO 43204 Gel 0.1% n=63 Participants Once daily treatment for two consecutive days LEO 43204 gel 0.1%	Total n=224 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=5 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	5 Participants n=21 Participants	3 Participants n=8 Participants	11 Participants n=8 Participants	9 Participants n=5 Participants	22 Participants n=24 Participants	23 Participants n=42 Participants	82 Participants n=42 Participants
Age, Categorical >=65 years	10 Participants n=7 Participants	9 Participants n=5 Participants	8 Participants n=4 Participants	7 Participants n=21 Participants	6 Participants n=8 Participants	21 Participants n=8 Participants	3 Participants n=5 Participants	38 Participants n=24 Participants	40 Participants n=42 Participants	142 Participants n=42 Participants
Sex: Female, Male Female	3 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	6 Participants n=8 Participants	15 Participants n=8 Participants	4 Participants n=5 Participants	24 Participants n=24 Participants	26 Participants n=42 Participants	96 Participants n=42 Participants
Sex: Female, Male Male	9 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	3 Participants n=8 Participants	17 Participants n=8 Participants	8 Participants n=5 Participants	36 Participants n=24 Participants	37 Participants n=42 Participants	128 Participants n=42 Participants
Region of Enrollment Canada	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=8 Participants	11 participants n=8 Participants	0 participants n=5 Participants	20 participants n=24 Participants	21 participants n=42 Participants	52 participants n=42 Participants
Region of Enrollment United States	12 participants n=7 Participants	12 participants n=5 Participants	12 participants n=4 Participants	12 participants n=21 Participants	9 participants n=8 Participants	21 participants n=8 Participants	12 participants n=5 Participants	40 participants n=24 Participants	42 participants n=42 Participants	172 participants n=42 Participants

PRIMARY outcome

Timeframe: From Day 1 up to and including Day 8

The number participants experiencing a DLT was used to identify the maximum tolerated dose(MTD) levels of LEO 43204 after once daily treatment for 2 consecutive days.The MTD was defined as the highest dose level at which less than 4 out of 12 participants experienced a DLT.

A DLT was defined as one or more of the following three LSRs:

• Crusting Grade 4
• Erosion/Ulceration Grade 4
• Vesiculation/Pustulation Grade 4

or two or more of the following five LSRs:

• Crusting Grade 3
• Swelling Grade 4
• Erosion/Ulceration Grade 3
• Vesiculation/Pustulation Grade 3

or other clinically relevant signs or symptoms observed, which the Investigator judged to be counted as a DLT.

The LSRs consists of the following 6 categories: Erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration. Each individual LSR category was given a numeric grade of severity from 0-4. Grade 0 being no presence and Grade 4 being the highest grade of severity.

Outcome measures

Measure	Part 1: LEO 43204 Gel 0.018% n=12 Participants Once daily treatment for two consecutive days with LEO 43204 gel 0.018%	Part 1: LEO 43204 Gel 0.025% n=12 Participants Once daily treatment for two consecutive days with LEO 43204 gel 0.025%	Part 1: LEO 43204 Gel 0.037% n=12 Participants Once daily treatment for two consecutive days with LEO 43204 gel 0.037%	Part 1: LEO 43204 Gel 0.05% n=12 Participants Once daily treatment for two consecutive days with LEO 43204 gel 0.05%	Part 1: LEO 43204 Gel 0.075% n=12 Participants Once daily treatment for two consecutive days with LEO 43204 gel 0.075%	Part 1: LEO 43204 Gel 0.1% n=9 Participants Once daily treatment for two consecutive days with LEO 43204 gel 0.1%
Part 1: Participants Experiencing Dose Limiting Toxicity (DLT) Based on Local Skin Responses (LSRs) Yes	0 Participants	0 Participants	2 Participants	1 Participants	1 Participants	0 Participants
Part 1: Participants Experiencing Dose Limiting Toxicity (DLT) Based on Local Skin Responses (LSRs) No	12 Participants	12 Participants	10 Participants	11 Participants	11 Participants	9 Participants

PRIMARY outcome

Timeframe: From baseline to Week 8

Percent reduction from baseline in clinically visible actinic keratosis lesions (AKs) identified in the treatment area.

Outcome measures

Measure	Part 1: LEO 43204 Gel 0.018% n=32 Participants Once daily treatment for two consecutive days with LEO 43204 gel 0.018%	Part 1: LEO 43204 Gel 0.025% n=60 Participants Once daily treatment for two consecutive days with LEO 43204 gel 0.025%	Part 1: LEO 43204 Gel 0.037% n=63 Participants Once daily treatment for two consecutive days with LEO 43204 gel 0.037%	Part 1: LEO 43204 Gel 0.05% Once daily treatment for two consecutive days with LEO 43204 gel 0.05%	Part 1: LEO 43204 Gel 0.075% Once daily treatment for two consecutive days with LEO 43204 gel 0.075%	Part 1: LEO 43204 Gel 0.1% Once daily treatment for two consecutive days with LEO 43204 gel 0.1%
Part 2: Percent Reduction From Baseline in Actinic Keratosis (AK) Count	32.7 percentage of reduction Interval 17.9 to 44.8	70.0 percentage of reduction Interval 64.1 to 74.9	62.2 percentage of reduction Interval 55.5 to 67.8	—	—	—

SECONDARY outcome

Timeframe: From baseline to Week 8

Complete clearance was defined as a 100% reduction from baseline in AK count.

Outcome measures

Measure	Part 1: LEO 43204 Gel 0.018% n=32 Participants Once daily treatment for two consecutive days with LEO 43204 gel 0.018%	Part 1: LEO 43204 Gel 0.025% n=60 Participants Once daily treatment for two consecutive days with LEO 43204 gel 0.025%	Part 1: LEO 43204 Gel 0.037% n=63 Participants Once daily treatment for two consecutive days with LEO 43204 gel 0.037%	Part 1: LEO 43204 Gel 0.05% Once daily treatment for two consecutive days with LEO 43204 gel 0.05%	Part 1: LEO 43204 Gel 0.075% Once daily treatment for two consecutive days with LEO 43204 gel 0.075%	Part 1: LEO 43204 Gel 0.1% Once daily treatment for two consecutive days with LEO 43204 gel 0.1%
Part 2: Participants With Complete Clearance of AKs (Last Observation Carried Forward [LOCF])	3 Participants	6 Participants	6 Participants	—	—	—

SECONDARY outcome

Timeframe: From baseline to Week 8

Partial clearance was defined as at least 75% reduction from baseline in AK count.

Outcome measures

Measure	Part 1: LEO 43204 Gel 0.018% n=32 Participants Once daily treatment for two consecutive days with LEO 43204 gel 0.018%	Part 1: LEO 43204 Gel 0.025% n=60 Participants Once daily treatment for two consecutive days with LEO 43204 gel 0.025%	Part 1: LEO 43204 Gel 0.037% n=63 Participants Once daily treatment for two consecutive days with LEO 43204 gel 0.037%	Part 1: LEO 43204 Gel 0.05% Once daily treatment for two consecutive days with LEO 43204 gel 0.05%	Part 1: LEO 43204 Gel 0.075% Once daily treatment for two consecutive days with LEO 43204 gel 0.075%	Part 1: LEO 43204 Gel 0.1% Once daily treatment for two consecutive days with LEO 43204 gel 0.1%
Part 2: Participants With Partial Clearance of AKs (LOCF)	5 Participants	27 Participants	28 Participants	—	—	—

Adverse Events

Part 1: LEO 43204 Gel 0.018%

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 1: LEO 43204 Gel 0.025%

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 1: LEO 43204 Gel 0.037%

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Part 1: LEO 43204 Gel 0.05%

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Part 1: LEO 43204 Gel 0.075%

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Part 1: LEO 43204 Gel 0.1%

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Part 2: LEO 43204 Vehicle Gel

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Part 2: LEO 43204 Gel 0.075%

Serious events: 1 serious events

Other events: 36 other events

Deaths: 0 deaths

Part 2: LEO 43204 Gel 0.1%

Serious events: 2 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Measure	Part 1: LEO 43204 Gel 0.018% n=12 participants at risk Once daily treatment for two consecutive days with LEO 43204 gel 0.018%	Part 1: LEO 43204 Gel 0.025% n=12 participants at risk Once daily treatment for two consecutive days with LEO 43204 gel 0.025%	Part 1: LEO 43204 Gel 0.037% n=12 participants at risk Once daily treatment for two consecutive days with LEO 43204 gel 0.037%	Part 1: LEO 43204 Gel 0.05% n=12 participants at risk Once daily treatment for two consecutive days with LEO 43204 gel 0.05%	Part 1: LEO 43204 Gel 0.075% n=12 participants at risk Once daily treatment for two consecutive days with LEO 43204 gel 0.075%	Part 1: LEO 43204 Gel 0.1% n=9 participants at risk Once daily treatment for two consecutive days with LEO 43204 gel 0.1%	Part 2: LEO 43204 Vehicle Gel n=32 participants at risk Once daily treatment for two consecutive days LEO 43204 vehicle gel	Part 2: LEO 43204 Gel 0.075% n=60 participants at risk Once daily treatment for two consecutive days LEO 43204 gel 0.075%	Part 2: LEO 43204 Gel 0.1% n=63 participants at risk Once daily treatment for two consecutive days LEO 43204 gel 0.1%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Keratoacanthoma	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Infections and infestations Urinary tract infection	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.7% 1/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8

Other adverse events

Measure	Part 1: LEO 43204 Gel 0.018% n=12 participants at risk Once daily treatment for two consecutive days with LEO 43204 gel 0.018%	Part 1: LEO 43204 Gel 0.025% n=12 participants at risk Once daily treatment for two consecutive days with LEO 43204 gel 0.025%	Part 1: LEO 43204 Gel 0.037% n=12 participants at risk Once daily treatment for two consecutive days with LEO 43204 gel 0.037%	Part 1: LEO 43204 Gel 0.05% n=12 participants at risk Once daily treatment for two consecutive days with LEO 43204 gel 0.05%	Part 1: LEO 43204 Gel 0.075% n=12 participants at risk Once daily treatment for two consecutive days with LEO 43204 gel 0.075%	Part 1: LEO 43204 Gel 0.1% n=9 participants at risk Once daily treatment for two consecutive days with LEO 43204 gel 0.1%	Part 2: LEO 43204 Vehicle Gel n=32 participants at risk Once daily treatment for two consecutive days LEO 43204 vehicle gel	Part 2: LEO 43204 Gel 0.075% n=60 participants at risk Once daily treatment for two consecutive days LEO 43204 gel 0.075%	Part 2: LEO 43204 Gel 0.1% n=63 participants at risk Once daily treatment for two consecutive days LEO 43204 gel 0.1%
General disorders Application site pruritus	16.7% 2/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	8.3% 1/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	33.3% 4/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	58.3% 7/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	58.3% 7/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	66.7% 6/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	3.1% 1/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	38.3% 23/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	41.3% 26/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
General disorders Application site pain	16.7% 2/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	8.3% 1/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	16.7% 2/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	50.0% 6/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	50.0% 6/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	33.3% 3/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	25.0% 15/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	36.5% 23/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
General disorders Application site paraesthesia	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	3.1% 1/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
General disorders Application site vesicles	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
General disorders Fatigue	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.7% 1/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
General disorders Foreign body reaction	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
General disorders Administration site reaction	8.3% 1/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	8.3% 1/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
General disorders Application site discomfort	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	11.1% 1/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
General disorders Application site inflammation	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	11.1% 1/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
General disorders Oedema peripheral	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	11.1% 1/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Infections and infestations Upper respiratory tract infection	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	3.1% 1/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	3.3% 2/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	4.8% 3/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Infections and infestations Nasopharyngitis	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	3.1% 1/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.7% 1/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Infections and infestations Bronchitis	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.7% 1/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Infections and infestations Helicobacter gastritis	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.7% 1/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Infections and infestations Sinusitis	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.7% 1/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Infections and infestations Viral infection	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.7% 1/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Infections and infestations Viral pharyngitis	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.7% 1/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Nervous system disorders Headache	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	3.3% 2/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	3.2% 2/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Nervous system disorders Dizziness	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	3.3% 2/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Nervous system disorders Hypoaesthesia	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Nervous system disorders Nerve compression	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	3.1% 1/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Nervous system disorders Restless legs syndrome	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.7% 1/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Nervous system disorders Tension headache	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	3.1% 1/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Nervous system disorders Tremor	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	11.1% 1/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Skin and subcutaneous tissue disorders Rash	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.7% 1/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	3.2% 2/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Skin and subcutaneous tissue disorders Erythema	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	3.3% 2/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	8.3% 1/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.7% 1/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	8.3% 1/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Skin and subcutaneous tissue disorders Eczema asteatotic	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Skin and subcutaneous tissue disorders Skin burning sensation	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	8.3% 1/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Injury, poisoning and procedural complications Contusion	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.7% 1/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Injury, poisoning and procedural complications Excoriation	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Injury, poisoning and procedural complications Fall	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.7% 1/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Injury, poisoning and procedural complications Muscle strain	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	8.3% 1/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.7% 1/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.7% 1/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.7% 1/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	3.2% 2/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	3.1% 1/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Eye disorders Conjunctivitis	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Eye disorders Dry eye	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.7% 1/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Eye disorders Eye irritation	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	8.3% 1/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Investigations Alanine aminotransferase increased	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.7% 1/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Investigations Electrocardiogram qt prolonged	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Investigations Platelet count increased	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Investigations Blood lactate dehydrogenase increased	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	8.3% 1/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.7% 1/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Musculoskeletal and connective tissue disorders Muscle twitching	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.7% 1/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	8.3% 1/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Gastrointestinal disorders Cheilitis	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Gastrointestinal disorders Dental caries	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Cardiac disorders Supraventricular tachycardia	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.7% 1/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Renal and urinary disorders Nephrolithiasis	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.7% 1/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Reproductive system and breast disorders Prostatomegaly	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Vascular disorders Haematoma	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	3.1% 1/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Ear and labyrinth disorders Vertigo	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	8.3% 1/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Psychiatric disorders Depression	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	8.3% 1/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Infections and infestations Urinary tract infection	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	8.3% 1/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/9 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.7% 1/60 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/63 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8

Additional Information

Clinical Trial Disclosure Specialist

LEO Pharma A/S

Email: disclosure@leo-pharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee LEO acknowledges the investigators right to publish the entire results of the study, irrespective of outcome. LEO retains the right to have any publication submitted to LEO for review. Investigators must undertake not to submit any part of their individual data for publication without the prior consent of LEO.
• Publication restrictions are in place

Restriction type: OTHER