Trial Outcomes & Findings for Efficacy and Safety of LEO 43204 in the Field Treatment of Actinic Keratosis on Face or Chest including12-month Follow-up (NCT NCT02549339)

NCT ID: NCT02549339

Last Updated: 2025-03-10

Results Overview

The number of clinically visible actinic keratosis lesions (AKs) identified in the treatment area was recorded at Day 1, Week 4, and Week 8. Complete clearance was defined as no clinically visible AKs in the treatment area. The table shows the percentage of mean number of subjects across imputations with complete clearance.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 383 participants
• Primary outcome timeframe: At Week 8
• Results posted on: 2025-03-10

Participant Flow

A total of 383 participants were enrolled across 5 countries: United States, Canada, Germany, Spain, and Italy. 74 were screening failures, and 309 participants were randomized to 1 of the 2 treatment groups.

Participant milestones

Measure	LEO 43204 0.018% Gel Treatment with LEO 43204 0.018% gel once daily for 3 consecutive days applied on full face or within a contiguous area of approximately 250 cm2 on the chest.	Vehicle Gel Treatment with vehicle gel once daily for 3 consecutive days applied on full face or within a contiguous area of approximately 250 cm2 on the chest.
3-day Treatment and 8-week Follow-up STARTED	205	104
3-day Treatment and 8-week Follow-up Treated	202	104
3-day Treatment and 8-week Follow-up COMPLETED	201	99
3-day Treatment and 8-week Follow-up NOT COMPLETED	4	5
12-month Follow-up STARTED	201	98
12-month Follow-up COMPLETED	192	87
12-month Follow-up NOT COMPLETED	9	11

Reasons for withdrawal

Measure	LEO 43204 0.018% Gel Treatment with LEO 43204 0.018% gel once daily for 3 consecutive days applied on full face or within a contiguous area of approximately 250 cm2 on the chest.	Vehicle Gel Treatment with vehicle gel once daily for 3 consecutive days applied on full face or within a contiguous area of approximately 250 cm2 on the chest.
3-day Treatment and 8-week Follow-up Protocol Violation	2	0
3-day Treatment and 8-week Follow-up Withdrawal by Subject	1	3
3-day Treatment and 8-week Follow-up Other	1	0
3-day Treatment and 8-week Follow-up Lost to Follow-up	0	2
12-month Follow-up Lack of Efficacy	0	2
12-month Follow-up Withdrawal by Subject	8	3
12-month Follow-up Lost to Follow-up	1	3
12-month Follow-up Other	0	3

Baseline Characteristics

Efficacy and Safety of LEO 43204 in the Field Treatment of Actinic Keratosis on Face or Chest including12-month Follow-up

Baseline characteristics by cohort

Measure	LEO 43204 0.018% Gel n=202 Participants Treatment once daily for 3 days with LEO 43204 0.018% gel	Vehicle Gel n=104 Participants Treatment once daily for 3 days with vehicle gel	Total n=306 Participants Total of all reporting groups
Age, Continuous	69.1 years STANDARD_DEVIATION 9.2 • n=5 Participants	66.3 years STANDARD_DEVIATION 9.1 • n=7 Participants	68.2 years STANDARD_DEVIATION 9.3 • n=5 Participants
Age, Customized Age group · 18-64 years	63 Participants n=5 Participants	38 Participants n=7 Participants	101 Participants n=5 Participants
Age, Customized Age group · 65-84 years	131 Participants n=5 Participants	65 Participants n=7 Participants	196 Participants n=5 Participants
Age, Customized Age group · >=85 years	8 Participants n=5 Participants	1 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Female	65 Participants n=5 Participants	41 Participants n=7 Participants	106 Participants n=5 Participants
Sex: Female, Male Male	137 Participants n=5 Participants	63 Participants n=7 Participants	200 Participants n=5 Participants
Region of Enrollment United States	103 Participants n=5 Participants	55 Participants n=7 Participants	158 Participants n=5 Participants
Region of Enrollment Canada	47 Participants n=5 Participants	26 Participants n=7 Participants	73 Participants n=5 Participants
Region of Enrollment Germany	26 Participants n=5 Participants	10 Participants n=7 Participants	36 Participants n=5 Participants
Region of Enrollment Spain	14 Participants n=5 Participants	7 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment Italy	12 Participants n=5 Participants	6 Participants n=7 Participants	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Week 8

The number of clinically visible actinic keratosis lesions (AKs) identified in the treatment area was recorded at Day 1, Week 4, and Week 8.

Complete clearance was defined as no clinically visible AKs in the treatment area.

The table shows the percentage of mean number of subjects across imputations with complete clearance.

Outcome measures

Measure	LEO 43204 0.018% Gel n=202 Participants Treatment once daily for 3 days with LEO 43204 0.018% gel	Vehicle Gel n=104 Participants Treatment once daily for 3 days with vehicle gel
Complete Clearance of Actinic Keratosis (AK)	20.4 percentage of participants Interval 14.9 to 26.0	2.9 percentage of participants Interval -0.3 to 6.1

SECONDARY outcome

Timeframe: At Week 8

The number of clinically visible AKs identified in the treatment area was recorded at Day 1, Week 4, and Week 8.

Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area.

The table shows the percentage of mean number of participants across imputations with partial clearance.

Outcome measures

Measure	LEO 43204 0.018% Gel n=202 Participants Treatment once daily for 3 days with LEO 43204 0.018% gel	Vehicle Gel n=104 Participants Treatment once daily for 3 days with vehicle gel
Percentage of Participants With Partial Clearance (Multiple Imputation)	60.3 percentage of participants Interval 53.5 to 67.1	10.7 percentage of participants Interval 4.7 to 16.7

SECONDARY outcome

Timeframe: At Week 4

The number of clinically visible AKs identified in the treatment area was recorded at Day 1, Week 4, and Week 8.

Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area.

The table shows the percentage of mean number of participants across imputations with partial clearance.

Outcome measures

Measure	LEO 43204 0.018% Gel n=202 Participants Treatment once daily for 3 days with LEO 43204 0.018% gel	Vehicle Gel n=104 Participants Treatment once daily for 3 days with vehicle gel
Percentage of Participants With Partial Clearance (Multiple Imputation)	61.1 percentage of participants Interval 54.4 to 67.8	10.8 percentage of participants Interval 4.8 to 16.9

SECONDARY outcome

Timeframe: At Week 8

The percent reduction at Week 8 from baseline was analysed using a negative binomial regression for the AK count at Week 8 with treatment group and pooled sites as factors and baseline count as offset variable (using multiple imputations to account for missing values). The table presents adjusted mean percent reduction at Week 8 from baseline.

Outcome measures

Measure	LEO 43204 0.018% Gel n=202 Participants Treatment once daily for 3 days with LEO 43204 0.018% gel	Vehicle Gel n=104 Participants Treatment once daily for 3 days with vehicle gel
Percent Reduction in AK Count in the Treatment Area Compared to Baseline	74.8 percentage of reduction Interval 71.8 to 77.4	15.0 percentage of reduction Interval 3.4 to 25.2

Adverse Events

LEO 43204 0.018% Gel

Serious events: 0 serious events

Other events: 136 other events

Deaths: 0 deaths

Vehicle Gel

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

LEO 43204 0.018% Gel - Extended Follow-up

Serious events: 1 serious events

Other events: 35 other events

Deaths: 0 deaths

Vehicle Gel - Extended Follow-up

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	LEO 43204 0.018% Gel n=202 participants at risk Treatment once daily for 3 days LEO 43204 0.018% gel	Vehicle Gel n=104 participants at risk Treatment once daily for 3 days Vehicle gel	LEO 43204 0.018% Gel - Extended Follow-up n=201 participants at risk Treatment once daily for 3 days LEO 43204 0.018% gel	Vehicle Gel - Extended Follow-up n=98 participants at risk Treatment once daily for 3 days Vehicle gel
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.50% 1/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"

Other adverse events

Measure	LEO 43204 0.018% Gel n=202 participants at risk Treatment once daily for 3 days LEO 43204 0.018% gel	Vehicle Gel n=104 participants at risk Treatment once daily for 3 days Vehicle gel	LEO 43204 0.018% Gel - Extended Follow-up n=201 participants at risk Treatment once daily for 3 days LEO 43204 0.018% gel	Vehicle Gel - Extended Follow-up n=98 participants at risk Treatment once daily for 3 days Vehicle gel
General disorders Application site pain	55.9% 113/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	4.8% 5/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
General disorders Application site pruritus	31.2% 63/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	4.8% 5/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	1.0% 1/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
General disorders Application site discomfort	4.5% 9/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	2.9% 3/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
General disorders Application site warmth	1.5% 3/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.96% 1/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
General disorders Application site paraesthesia	0.99% 2/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.96% 1/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
General disorders Chills	1.5% 3/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
General disorders Pain	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.96% 1/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
General disorders Application site dryness	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
General disorders Application site haematoma	0.00% 0/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.96% 1/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
General disorders Application site laceration	0.00% 0/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.96% 1/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
General disorders Application site nodule	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
General disorders Chest discomfort	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
General disorders Facial pain	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
General disorders Hangover	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
General disorders Pyrexia	0.00% 0/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.96% 1/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Eye disorders Periorbital oedema	4.0% 8/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Eye disorders Eye irritation	2.0% 4/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.96% 1/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Eye disorders Lacrimation increased	0.99% 2/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.96% 1/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Eye disorders Eye pain	0.99% 2/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Eye disorders Conjunctival haemorrhage	0.00% 0/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.96% 1/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Eye disorders Dry eye	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Eye disorders Eczema eyelids	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Eye disorders Eyelid oedema	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Eye disorders Eyelid pain	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Eye disorders Photophobia	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Eye disorders Vision blurred	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Infections and infestations Upper respiratory tract infection	3.0% 6/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.96% 1/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Infections and infestations Nasopharyngitis	1.5% 3/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.96% 1/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Infections and infestations Rhinitis	1.5% 3/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Infections and infestations Herpes simplex	0.99% 2/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.50% 1/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	1.0% 1/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Infections and infestations Application site infection	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Infections and infestations Cellulitis	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Infections and infestations Conjunctivitis	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Infections and infestations Folliculitis	0.00% 0/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.96% 1/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Infections and infestations Furuncle	0.00% 0/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.96% 1/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Infections and infestations Influenza	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Infections and infestations Sinusitis	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Injury, poisoning and procedural complications Laceration	2.0% 4/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Injury, poisoning and procedural complications Fall	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.96% 1/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Injury, poisoning and procedural complications Ligament sprain	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.96% 1/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Injury, poisoning and procedural complications Skin abrasion	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.96% 1/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Injury, poisoning and procedural complications Accidental exposure to product	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.96% 1/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Injury, poisoning and procedural complications Concussion	0.00% 0/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.96% 1/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Injury, poisoning and procedural complications Face injury	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Injury, poisoning and procedural complications Muscle strain	0.00% 0/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.96% 1/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Injury, poisoning and procedural complications Periorbital haematoma	0.00% 0/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.96% 1/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Injury, poisoning and procedural complications Sunburn	0.00% 0/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.96% 1/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	2.5% 5/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	2.9% 3/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	4.5% 9/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	1.0% 1/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	2.5% 5/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	3.0% 6/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	3.1% 3/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	1.9% 2/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	5.0% 10/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	2.0% 2/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Nervous system disorders Headache	5.9% 12/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Nervous system disorders Anosmia	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Nervous system disorders Sciatica	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Nervous system disorders Tension headache	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Musculoskeletal and connective tissue disorders Arthralgia	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	1.9% 2/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.96% 1/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Musculoskeletal and connective tissue disorders Exostosis	0.00% 0/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.96% 1/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.96% 1/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Musculoskeletal and connective tissue disorders Myalgia	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.96% 1/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	1.9% 2/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.96% 1/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Respiratory, thoracic and mediastinal disorders Cough	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Respiratory, thoracic and mediastinal disorders Dysphonia	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Respiratory, thoracic and mediastinal disorders Epistaxis	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Gastrointestinal disorders Nausea	0.99% 2/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Gastrointestinal disorders Vomiting	0.99% 2/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Gastrointestinal disorders Rectal polyp	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Psychiatric disorders Insomnia	1.5% 3/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Psychiatric disorders Anxiety	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Psychiatric disorders Depression	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Psychiatric disorders Sleep disorder	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Reproductive system and breast disorders Prostatitis	0.99% 2/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Reproductive system and breast disorders Prostatomegaly	0.00% 0/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.96% 1/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Skin and subcutaneous tissue disorders Ingrowing nail	0.00% 0/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.96% 1/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Skin and subcutaneous tissue disorders Intertrigo	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Skin and subcutaneous tissue disorders Post inflammatory pigmentation change	0.00% 0/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.96% 1/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	2.0% 4/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	1.0% 1/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Investigations Blood creatinine increased	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Investigations Liver function test abnormal	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Metabolism and nutrition disorders Hyperglycaemia	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Metabolism and nutrition disorders Hyperkalaemia	0.50% 1/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Vascular disorders Hypertension	0.00% 0/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.96% 1/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	0.00% 0/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	2.0% 2/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.50% 1/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.00% 0/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	1.5% 3/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Skin and subcutaneous tissue disorders Hypertrophic scar	0.00% 0/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	1.00% 2/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Skin and subcutaneous tissue disorders Papule	0.00% 0/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.50% 1/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Skin and subcutaneous tissue disorders Rosacea	0.00% 0/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.50% 1/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
General disorders Application site scar	0.00% 0/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	1.5% 3/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	3.1% 3/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
General disorders Application site discolouration	0.00% 0/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.50% 1/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	1.0% 1/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
General disorders Application site dermatitis	0.00% 0/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.50% 1/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
General disorders Application site macule	0.00% 0/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	1.0% 1/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Infections and infestations Postoperative wound infection	0.00% 0/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.50% 1/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"
Injury, poisoning and procedural complications Scar	0.00% 0/202 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/104 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	0.00% 0/201 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"	1.0% 1/98 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information"

Additional Information

Clinical Trial Disclosure Specialist

LEO Pharma A/S

Email: disclosure@leo-pharma.com

Results disclosure agreements

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

Restriction type: OTHER