Trial Outcomes & Findings for A Study of Increasing Strengths, Safety and Efficacy of Two Formulas of LEO 43204 on the Face or the Chest in Patients With Actinic Keratosis (NCT NCT01922050)

NCT ID: NCT01922050

Last Updated: 2025-03-06

Results Overview

The number of participants experiencing DLTs are tabulated by treatment group. This was used to identify the maximum tolerated dose (MTD) of LEO 43204 after once daily treatment for 2 consecutive days.The MTD was defined as the highest dose level with less than 4 out of 12 participants(cohorts 1 to 4) or less than 6 out of 18 participants(cohorts 5 and 6) experiencing a DLT DLT was defined as one or more of the following 3 LSRs: * Crusting Grade 4 * Erosion/Ulceration Grade 4 * Vesiculation/Pustulation Grade 4 or two or more of the following five LSRs: * Erythema Grade 4 * Crusting Grade 3 * Swelling Grade 4 * Erosion/Ulceration Grade 3 * Vesiculation/Pustulation Grade 3 The Local Skin Responses consists of the following 6 categories: Erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration. Each individual LSR category are given a numeric grade of severity from 0-4. Grade 0 being no presence and 4 being the highest grade of severity.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

320 participants

Primary outcome timeframe

From Day 1 up to and including Day 8

Results posted on

2025-03-06

Participant Flow

Participant milestones

Participant milestones
Measure	Part 1: LEO 43204 Gel 0.0015 Part 1: Dose-Escalation LEO 43204 gel 0.0015% applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest.	Part 1: LEO 43204 Gel 0.003 Part 1: Dose-Escalation LEO 43204 gel 0.003% applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest.	Part 1: LEO 43204 Gel 0.006 Part 1: Dose-Escalation LEO 43204 gel 0.006% applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest.	Part 1: LEO 43204 Gel 0.012 Part 1: Dose-Escalation LEO 43204 gel 0.012% applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest.	Part 1: LEO 43204 Gel 0.018 Part 1: Dose-Escalation LEO 43204 gel 0.018% applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest.	Part 1: LEO 43204 Gel 0.025 Part 1: Dose-Escalation LEO 43204 gel 0.025% applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest.	Part 1: LEO 43204 Cream 0.0015 Part 1: Dose-Escalation LEO 43204 cream 0.0015% applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest.	Part 1: LEO 43204 Cream 0.003 Part 1: Dose-Escalation LEO 43204 cream 0.003% applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest.	Part 1: LEO 43204 Cream 0.006 Part 1: Dose-Escalation LEO 43204 cream 0.006% applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest.	Part 1: LEO 43204 Cream 0.012 Part 1: Dose-Escalation LEO 43204 cream 0.0012% applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest.	Part 2: LEO 43204 Gel 0.006 Part 2: Double-Blind phase LEO 43204 gel 0.006% applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest. The first treatment was to be applied on Day 1 by the participant at the site under supervision of the study staff. The second treatment was applied by the participant on Day 2 at home.	Part 2: LEO 43204 Gel 0.012 Part 2: Double-Blind phase LEO 43204 gel 0.012% applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest. The first treatment was to be applied on Day 1 by the participant at the site under supervision of the study staff. The second treatment was applied by the participant on Day 2 at home.	Part 2: LEO 43204 Gel 0.018 Part 2: Double-Blind phase LEO 43204 gel 0.018% applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest. The first treatment was to be applied on Day 1 by the participant at the site under supervision of the study staff. The second treatment was applied by the participant on Day 2 at home.	Part 2: LEO 43204 Gel Vehicle Part 2: Double-Blind phase LEO 43204 gel vehicle applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest. The first treatment was to be applied on Day 1 by the participant at the site under supervision of the study staff. The second treatment was applied by the participant on Day 2 at home.
Part 1 Open-label, Dose-escalation Phase STARTED	3	3	6	6	17	18	3	3	6	12	0	0	0	0
Part 1 Open-label, Dose-escalation Phase COMPLETED	3	3	6	6	17	18	3	3	6	12	0	0	0	0
Part 1 Open-label, Dose-escalation Phase NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Part 2 Double-blind Phase STARTED	0	0	0	0	0	0	0	0	0	0	62	60	62	59
Part 2 Double-blind Phase COMPLETED	0	0	0	0	0	0	0	0	0	0	61	58	62	56
Part 2 Double-blind Phase NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	1	2	0	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Increasing Strengths, Safety and Efficacy of Two Formulas of LEO 43204 on the Face or the Chest in Patients With Actinic Keratosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: LEO 43204 Gel 0.0015 n=3 Participants Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: LEO 43204 Gel 0.003 n=3 Participants Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: LEO 43204 Gel 0.006 n=6 Participants Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: LEO 43204 Gel 0.012 n=6 Participants Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: LEO 43204 Gel 0.018 n=17 Participants Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: LEO 43204 Gel 0.025 n=18 Participants Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: LEO 43204 Cream 0.0015 n=3 Participants Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: LEO 43204 Cream 0.003 n=3 Participants Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: LEO 43204 Cream 0.006 n=6 Participants Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: LEO 43204 Cream 0.012 n=12 Participants Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 2: LEO 43204 Gel Vehicle n=59 Participants Part 2: Double-Blind, Once-Daily, 2-Day Treatment	Part 2: LEO 43204 Gel 0.006 n=62 Participants Part 2: Double-Blind, Once-Daily, 2-Day Treatment	Part 2: LEO 43204 Gel 0.012 n=60 Participants Part 2: Double-Blind, Once-Daily, 2-Day Treatment	Part 2: LEO 43204 Gel 0.018 n=62 Participants Part 2: Double-Blind, Once-Daily, 2-Day Treatment	Total n=320 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	10 Participants n=21 Participants	6 Participants n=8 Participants	2 Participants n=8 Participants	0 Participants n=24 Participants	4 Participants n=42 Participants	5 Participants n=42 Participants	18 Participants n=42 Participants	17 Participants n=42 Participants	21 Participants n=36 Participants	21 Participants n=36 Participants	110 Participants n=24 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants	7 Participants n=21 Participants	12 Participants n=8 Participants	1 Participants n=8 Participants	3 Participants n=24 Participants	2 Participants n=42 Participants	7 Participants n=42 Participants	41 Participants n=42 Participants	45 Participants n=42 Participants	39 Participants n=36 Participants	41 Participants n=36 Participants	210 Participants n=24 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	6 Participants n=21 Participants	6 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	5 Participants n=42 Participants	17 Participants n=42 Participants	20 Participants n=42 Participants	19 Participants n=36 Participants	21 Participants n=36 Participants	103 Participants n=24 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	11 Participants n=21 Participants	12 Participants n=8 Participants	3 Participants n=8 Participants	3 Participants n=24 Participants	5 Participants n=42 Participants	7 Participants n=42 Participants	42 Participants n=42 Participants	42 Participants n=42 Participants	41 Participants n=36 Participants	41 Participants n=36 Participants	217 Participants n=24 Participants
Region of Enrollment Canada	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	32 Participants n=42 Participants	31 Participants n=42 Participants	31 Participants n=36 Participants	32 Participants n=36 Participants	126 Participants n=24 Participants
Region of Enrollment United States	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	17 Participants n=21 Participants	18 Participants n=8 Participants	3 Participants n=8 Participants	3 Participants n=24 Participants	6 Participants n=42 Participants	12 Participants n=42 Participants	27 Participants n=42 Participants	31 Participants n=42 Participants	29 Participants n=36 Participants	30 Participants n=36 Participants	194 Participants n=24 Participants

PRIMARY outcome

Timeframe: From Day 1 up to and including Day 8

Outcome measures

Outcome measures
Measure	Part 1: Cohort 1: LEO 43204 Gel 0.0015 n=3 Participants Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: Cohort 2: LEO 43204 Gel 0.003 n=3 Participants Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: Cohort 3: LEO 43204 Gel 0.006 n=6 Participants Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: Cohort 4: LEO 43204 Gel 0.012 n=6 Participants Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: Cohort 5: LEO 43204 Gel 0.018 n=17 Participants Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: Cohort 6: LEO 43204 Gel 0.025 n=18 Participants Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: Cohort 1: LEO 43204 Cream 0.0015 n=3 Participants Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: Cohort 2: LEO 43204 Cream 0.003 n=3 Participants Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: Cohort 3: LEO 43204 Cream 0.006 n=6 Participants Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: Cohort 4: LEO 43204 Cream 0.012 n=12 Participants Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment
Part 1: Number of Participants Experiencing a Dose Limiting Toxicity (DLT) Based on Local Skin Responses (LSRs) No	3 Participants	3 Participants	6 Participants	6 Participants	17 Participants	12 Participants	3 Participants	3 Participants	6 Participants	9 Participants
Part 1: Number of Participants Experiencing a Dose Limiting Toxicity (DLT) Based on Local Skin Responses (LSRs) Yes	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	6 Participants	0 Participants	0 Participants	0 Participants	3 Participants

PRIMARY outcome

Timeframe: At Week 8

Population: The analysis was based on the Full Analysis Set, which was defined as all randomized participants who applied investigation product. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and thus was excluded from the efficacy analysis.

Outcome measures

Outcome measures
Measure	Part 1: Cohort 1: LEO 43204 Gel 0.0015 n=58 Participants Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: Cohort 2: LEO 43204 Gel 0.003 n=62 Participants Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: Cohort 3: LEO 43204 Gel 0.006 n=60 Participants Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: Cohort 4: LEO 43204 Gel 0.012 n=62 Participants Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: Cohort 5: LEO 43204 Gel 0.018 Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: Cohort 6: LEO 43204 Gel 0.025 Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: Cohort 1: LEO 43204 Cream 0.0015 Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: Cohort 2: LEO 43204 Cream 0.003 Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: Cohort 3: LEO 43204 Cream 0.006 Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: Cohort 4: LEO 43204 Cream 0.012 Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment
Part 2: Percent Reduction From Baseline in Actinic Keratosis (AK) Counts (Multiple Imputation)	42.3 percentage of reduction Interval 30.5 to 52.1	69.7 percentage of reduction Interval 63.1 to 75.1	73.4 percentage of reduction Interval 67.1 to 78.5	79.0 percentage of reduction Interval 74.0 to 83.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At Week 8

Complete clearance was defined as a 100% reduction from baseline in AK count. For treatment groups Vehicle, 0.006 and 0.012 the table shows the percentage of mean number of participants across imputations with complete clearance. For treatment group 0.018 the table shows the percentage of mean number of participants with complete clearance in observed cases.

Outcome measures

Outcome measures
Measure	Part 1: Cohort 1: LEO 43204 Gel 0.0015 n=58 Participants Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: Cohort 2: LEO 43204 Gel 0.003 n=62 Participants Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: Cohort 3: LEO 43204 Gel 0.006 n=60 Participants Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: Cohort 4: LEO 43204 Gel 0.012 n=62 Participants Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: Cohort 5: LEO 43204 Gel 0.018 Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: Cohort 6: LEO 43204 Gel 0.025 Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: Cohort 1: LEO 43204 Cream 0.0015 Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: Cohort 2: LEO 43204 Cream 0.003 Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: Cohort 3: LEO 43204 Cream 0.006 Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: Cohort 4: LEO 43204 Cream 0.012 Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment
Part 2: Percentage of Participants With Complete Clearance of Actinic Keratosis Lesions (AKs) (Multiple Imputation)	12.2 percentage of participants Interval 3.7 to 20.7	9.9 percentage of participants Interval 2.4 to 17.3	18.8 percentage of participants Interval 8.8 to 28.8	24.2 percentage of participants Interval 13.5 to 34.9	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At Week 8

Partial clearance was defined as at least 75% reduction from baseline in AK count. For treatment groups Vehicle, 0.006 and 0.012 the table shows the percentage of mean number of participants across imputations with partial clearance. For treatment group 0.018 the table shows the percentage of mean number of participants with partial clearance in observed cases.

Outcome measures

Outcome measures
Measure	Part 1: Cohort 1: LEO 43204 Gel 0.0015 n=58 Participants Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: Cohort 2: LEO 43204 Gel 0.003 n=62 Participants Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: Cohort 3: LEO 43204 Gel 0.006 n=60 Participants Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: Cohort 4: LEO 43204 Gel 0.012 n=62 Participants Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: Cohort 5: LEO 43204 Gel 0.018 Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: Cohort 6: LEO 43204 Gel 0.025 Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: Cohort 1: LEO 43204 Cream 0.0015 Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: Cohort 2: LEO 43204 Cream 0.003 Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: Cohort 3: LEO 43204 Cream 0.006 Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: Cohort 4: LEO 43204 Cream 0.012 Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment
Part 2: Percentage of Participants With Partial Clearance of AKs (Multiple Imputation)	29.9 percentage of participants Interval 18.0 to 41.9	52.4 percentage of participants Interval 39.9 to 64.9	54.5 percentage of participants Interval 41.8 to 67.2	62.9 percentage of participants Interval 50.9 to 74.9	—	—	—	—	—	—

Adverse Events

Part 1: LEO 43204 Gel 0.0015

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 1: LEO 43204 Gel 0.003

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 1: LEO 43204 Gel 0.006

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Part 1: LEO 43204 Gel 0.012

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Part 1: LEO 43204 Gel 0.018

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Part 1: LEO 43204 Gel 0.025

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Part 1: LEO 43204 Cream 0.0015

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 1: LEO 43204 Cream 0.003

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 1: LEO 43204 Cream 0.006

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 1: LEO 43204 Cream 0.012

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Part 2: LEO 43204 Gel Vehicle

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Part 2: LEO 43204 Gel 0.006

Serious events: 5 serious events

Other events: 38 other events

Deaths: 0 deaths

Part 2: LEO 43204 Gel 0.012

Serious events: 2 serious events

Other events: 40 other events

Deaths: 0 deaths

Part 2: LEO 43204 Gel 0.018

Serious events: 0 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part 1: LEO 43204 Gel 0.0015 n=3 participants at risk Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: LEO 43204 Gel 0.003 n=3 participants at risk Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: LEO 43204 Gel 0.006 n=6 participants at risk Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: LEO 43204 Gel 0.012 n=6 participants at risk Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: LEO 43204 Gel 0.018 n=17 participants at risk Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: LEO 43204 Gel 0.025 n=18 participants at risk Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: LEO 43204 Cream 0.0015 n=3 participants at risk Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: LEO 43204 Cream 0.003 n=3 participants at risk Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: LEO 43204 Cream 0.006 n=6 participants at risk Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: LEO 43204 Cream 0.012 n=12 participants at risk Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 2: LEO 43204 Gel Vehicle n=58 participants at risk Part 2: Double-Blind, Once-Daily, 2-Day Treatment	Part 2: LEO 43204 Gel 0.006 n=62 participants at risk Part 2: Double-Blind, Once-Daily, 2-Day Treatment	Part 2: LEO 43204 Gel 0.012 n=60 participants at risk Part 2: Double-Blind, Once-Daily, 2-Day Treatment	Part 2: LEO 43204 Gel 0.018 n=62 participants at risk Part 2: Double-Blind, Once-Daily, 2-Day Treatment
Cardiac disorders Bradycardia	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.7% 1/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Cardiac disorders Myocardial infarction	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Cardiac disorders Ventricular fibrillation	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
General disorders Chest pain	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	3.2% 2/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.7% 1/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	16.7% 1/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Nervous system disorders Convulsion	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	5.9% 1/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.

Other adverse events

Other adverse events
Measure	Part 1: LEO 43204 Gel 0.0015 n=3 participants at risk Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: LEO 43204 Gel 0.003 n=3 participants at risk Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: LEO 43204 Gel 0.006 n=6 participants at risk Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: LEO 43204 Gel 0.012 n=6 participants at risk Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: LEO 43204 Gel 0.018 n=17 participants at risk Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: LEO 43204 Gel 0.025 n=18 participants at risk Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: LEO 43204 Cream 0.0015 n=3 participants at risk Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: LEO 43204 Cream 0.003 n=3 participants at risk Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: LEO 43204 Cream 0.006 n=6 participants at risk Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 1: LEO 43204 Cream 0.012 n=12 participants at risk Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment	Part 2: LEO 43204 Gel Vehicle n=58 participants at risk Part 2: Double-Blind, Once-Daily, 2-Day Treatment	Part 2: LEO 43204 Gel 0.006 n=62 participants at risk Part 2: Double-Blind, Once-Daily, 2-Day Treatment	Part 2: LEO 43204 Gel 0.012 n=60 participants at risk Part 2: Double-Blind, Once-Daily, 2-Day Treatment	Part 2: LEO 43204 Gel 0.018 n=62 participants at risk Part 2: Double-Blind, Once-Daily, 2-Day Treatment
General disorders Application site pain	33.3% 1/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	33.3% 1/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	33.3% 2/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	50.0% 3/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	17.6% 3/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	44.4% 8/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	33.3% 1/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	41.7% 5/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	8.6% 5/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	40.3% 25/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	55.0% 33/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	59.7% 37/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
General disorders Application site pruritus	33.3% 1/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	33.3% 1/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	33.3% 2/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	66.7% 4/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	11.8% 2/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	5.6% 1/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	33.3% 4/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.7% 1/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	22.6% 14/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	23.3% 14/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	25.8% 16/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
General disorders Application site erythema	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	33.3% 2/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	16.7% 1/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	11.8% 2/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	5.6% 1/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	16.7% 1/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	25.0% 3/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
General disorders Application site discolouration	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	5.6% 1/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
General disorders Application site discomfort	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	5.6% 1/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	8.3% 1/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	6.5% 4/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	3.3% 2/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	9.7% 6/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
General disorders Application site exfoliation	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	5.9% 1/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
General disorders Application site oedema	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	5.9% 1/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.7% 1/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
General disorders Application site photosensitivity reaction	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	5.9% 1/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Eye disorders Eye irritation	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	16.7% 1/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	5.9% 1/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Eye disorders Dry eye	33.3% 1/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Eye disorders Eyelid oedema	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	5.6% 1/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.7% 1/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Eye disorders Periorbital oedema	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	5.6% 1/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	8.3% 1/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	3.3% 2/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	3.2% 2/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Eye disorders Scintillating scotoma	33.3% 1/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Infections and infestations Herpes simplex	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	5.9% 1/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.7% 1/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Infections and infestations Nasopharyngitis	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	16.7% 1/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	5.9% 1/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	3.2% 2/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Infections and infestations Viral infection	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	5.9% 1/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.7% 1/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	16.7% 1/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	8.3% 1/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Nervous system disorders Headache	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	33.3% 1/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	11.8% 2/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	5.6% 1/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	6.5% 4/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	10.0% 6/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	8.1% 5/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Nervous system disorders Sciatica	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	16.7% 1/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	3.2% 2/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Gastrointestinal disorders Cheilitis	33.3% 1/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	8.3% 1/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Gastrointestinal disorders Glossodynia	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	16.7% 1/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Gastrointestinal disorders Nausea	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	5.6% 1/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	33.3% 1/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Renal and urinary disorders Haematuria	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	16.7% 1/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Renal and urinary disorders Polyuria	33.3% 1/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	16.7% 1/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Investigations Hepatic enzyme increased	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	5.9% 1/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	5.6% 1/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	16.7% 1/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.7% 1/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Vascular disorders Hypertension	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	5.9% 1/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
General disorders Application site warmth	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	8.3% 1/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Eye disorders Conjunctival hyperaemia	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	8.3% 1/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Infections and infestations Urinary tract infection	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	16.7% 1/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	8.3% 1/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	16.7% 1/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Renal and urinary disorders Renal colic	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	8.3% 1/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Vascular disorders Flushing	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	33.3% 1/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
General disorders Application site paraesthesia	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.7% 1/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	3.2% 2/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.7% 1/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	3.2% 2/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
General disorders Application site dermatitis	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
General disorders Application site irritation	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	3.2% 2/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
General disorders Application site swelling	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
General disorders Chills	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
General disorders Fatigue	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.7% 1/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Nervous system disorders Dizziness	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Nervous system disorders Neuralgia	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Nervous system disorders Presyncope	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.7% 1/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Nervous system disorders Tension headache	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Infections and infestations Gastroenteritis	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.7% 1/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Infections and infestations Herpes zoster	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Infections and infestations Hordeolum	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Infections and infestations Infection	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Infections and infestations Pneumonia	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.7% 1/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Infections and infestations Oral herpes	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	3.3% 2/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.7% 1/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	6.5% 4/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Skin and subcutaneous tissue disorders Acne	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.7% 1/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.7% 1/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.7% 1/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Skin and subcutaneous tissue disorders Granuloma skin	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.7% 1/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.7% 1/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Gastrointestinal disorders Vomiting	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	3.4% 2/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.7% 1/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Gastrointestinal disorders Dental caries	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Gastrointestinal disorders Toothache	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.7% 1/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Injury, poisoning and procedural complications Contusion	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.7% 1/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Injury, poisoning and procedural complications Excoriation	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.7% 1/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Injury, poisoning and procedural complications Ligament injury	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.7% 1/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Injury, poisoning and procedural complications Lip injury	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.7% 1/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Injury, poisoning and procedural complications Periorbital haemorrhage	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.7% 1/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Eye disorders Eye pain	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.7% 1/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.7% 1/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Musculoskeletal and connective tissue disorders Joint hyperextension	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.7% 1/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Cardiac disorders Angina pectoris	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Cardiac disorders Atrioventricular block first degree	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Psychiatric disorders Insomnia	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.7% 1/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Psychiatric disorders Anxiety	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Psychiatric disorders Depression	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Investigations Electrocardiogram abnormal	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.7% 1/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Investigations White blood cell count increased	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.7% 1/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Vascular disorders Haematoma	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Ear and labyrinth disorders Ear pain	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.7% 1/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Hepatobiliary disorders Hepatic steatosis	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.7% 1/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Renal and urinary disorders Renal failure chronic	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/17 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/18 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/3 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/6 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/12 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/58 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	1.6% 1/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/60 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.	0.00% 0/62 • From Day 1 to Week 8 The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.

Additional Information

Clinical Trial Disclosure Specialist

LEO Pharma A/S

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee LEO acknowledges the investigator's 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