Trial Outcomes & Findings for A Dose-Finding Study of GSK2894512 Cream in Subjects With Atopic Dermatitis (AD) (NCT NCT02564055)

NCT ID: NCT02564055

Last Updated: 2017-11-20

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

247 participants

Primary outcome timeframe

Baseline and up to Week 12

Results posted on

2017-11-20

Participant Flow

Eligible participants entered a 4 weeks screening phase and participants who met the eligibility criteria entered into the 12 weeks double-blind treatment phase and 4 weeks post-treatment follow-up phase. The total duration of participation in the study was 16 to 20 weeks.

A total of 363 adolescent and adult participants with atopic dermatitis (AD) were screened, of which 116 were screen failures and 247 entered the treatment phase. Participants in the treatment phase were randomized to receive GSK2894512 cream (0.5 or 1%) or vehicle control once daily (QD) or twice daily (BID).

Participant milestones

Participant milestones
Measure	GSK2894512 1% BID Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% QD Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks.	Vehicle QD Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks.
Overall Study STARTED	40	41	43	41	42	40
Overall Study COMPLETED	34	36	31	35	27	28
Overall Study NOT COMPLETED	6	5	12	6	15	12

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK2894512 1% BID Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% QD Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks.	Vehicle QD Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks.
Overall Study Adverse Event	1	0	4	1	4	1
Overall Study Protocol Violation	1	0	0	0	0	0
Overall Study Reached stopping criteria	0	0	0	0	0	1
Overall Study Lost to Follow-up	0	1	4	2	1	0
Overall Study Physician Decision	0	0	1	0	0	0
Overall Study Withdrawal by Subject	4	4	3	3	10	10

Baseline Characteristics

A Dose-Finding Study of GSK2894512 Cream in Subjects With Atopic Dermatitis (AD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK2894512 1% BID n=40 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=41 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=43 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% QD n=41 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=42 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=40 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	Total n=247 Participants Total of all reporting groups
Age, Continuous	28.5 Years STANDARD_DEVIATION 13.90 • n=5 Participants	31.6 Years STANDARD_DEVIATION 15.72 • n=7 Participants	29.0 Years STANDARD_DEVIATION 15.91 • n=5 Participants	29.3 Years STANDARD_DEVIATION 14.02 • n=4 Participants	27.9 Years STANDARD_DEVIATION 14.72 • n=21 Participants	29.4 Years STANDARD_DEVIATION 15.15 • n=8 Participants	29.3 Years STANDARD_DEVIATION 14.83 • n=8 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	24 Participants n=7 Participants	17 Participants n=5 Participants	22 Participants n=4 Participants	23 Participants n=21 Participants	17 Participants n=8 Participants	121 Participants n=8 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	17 Participants n=7 Participants	26 Participants n=5 Participants	19 Participants n=4 Participants	19 Participants n=21 Participants	23 Participants n=8 Participants	126 Participants n=8 Participants
Race/Ethnicity, Customized Race/Ethnicity, Customized · White/Caucasian	16 Participants n=5 Participants	18 Participants n=7 Participants	17 Participants n=5 Participants	17 Participants n=4 Participants	20 Participants n=21 Participants	12 Participants n=8 Participants	100 Participants n=8 Participants
Race/Ethnicity, Customized Race/Ethnicity, Customized · Black/African American	7 Participants n=5 Participants	10 Participants n=7 Participants	11 Participants n=5 Participants	12 Participants n=4 Participants	6 Participants n=21 Participants	12 Participants n=8 Participants	58 Participants n=8 Participants
Race/Ethnicity, Customized Race/Ethnicity, Customized · American Indian/Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized Race/Ethnicity, Customized · Asian/S.E. Asian Descent/Japanese	15 Participants n=5 Participants	13 Participants n=7 Participants	13 Participants n=5 Participants	10 Participants n=4 Participants	15 Participants n=21 Participants	14 Participants n=8 Participants	80 Participants n=8 Participants
Race/Ethnicity, Customized Race/Ethnicity, Customized · American Indian/Alaska Native and African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized Race/Ethnicity, Customized · Asian/S.E. Asian/Japanese and African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants
Race/Ethnicity, Customized Race/Ethnicity, Customized · Asian/S.E. Asian/Japanese and Black and White	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized Race/Ethnicity, Customized · Asian/S.E. Asian/Japanese and White/Caucasian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized Race/Ethnicity, Customized · Black/African American and White/Caucasian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	3 Participants n=8 Participants

PRIMARY outcome

Timeframe: Baseline and up to Week 12

Population: ITT Population. Only those participants with data available at specified data points were analyzed.

Outcome measures

Outcome measures
Measure	GSK2894512 0.5% QD n=35 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=28 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=25 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	GSK2894512 1% BID n=36 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=37 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=32 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
Percentage of Participants Who Have an Investigator Global Assessment (IGA) Score of Clear or Almost Clear (0 or 1) at Week 12 and a Minimum 2 Grade Improvement in IGA Score From Baseline to Week 12 for Intent to Treat (ITT) Population	40 Percentage of participant	36 Percentage of participant	44 Percentage of participant	58 Percentage of participant	51 Percentage of participant	50 Percentage of participant

SECONDARY outcome

Timeframe: Baseline and up to Week 12

Population: ITT Population

NRS is a 11-point tool ranging from 0 (absent) to 10 (worst imaginable) to assess the severity of 11 disease-related signs and symptoms including itching, discoloration, bleeding, oozing, cracking, scaling, flaking, dry/rough, painful, burning, and stinging. Participants were asked to complete the self-administered sign and symptom severity diary containing NRS using a recall period of the past 24 hours. Question 1 of the diary was used to assess itch. Mean change from Baseline to Week 12 in weekly average of daily itch/pruritus based on the NRS was presented using mean and standard deviation (SD). Baseline was defined as the latest assessment prior to first dose and Change from Baseline was defined as post-dose weekly average value minus Baseline value.

Outcome measures

Outcome measures
Measure	GSK2894512 0.5% QD n=41 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=42 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=40 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	GSK2894512 1% BID n=40 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=41 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=43 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
Mean Change From Baseline in Weekly Average of Daily Itch/Pruritus (Numeric Rating Scale [NRS]) Score	-3.39 Scores on a scale Standard Deviation 2.297	-0.95 Scores on a scale Standard Deviation 2.107	-3.50 Scores on a scale Standard Deviation 2.742	-3.06 Scores on a scale Standard Deviation 2.657	-3.10 Scores on a scale Standard Deviation 2.493	-3.52 Scores on a scale Standard Deviation 2.307

SECONDARY outcome

Timeframe: Baseline and up to Week 12

Population: ITT Population

NRS is a 11-point tool ranging from 0 (absent) to 10 (worst imaginable) to assess the severity of 11 disease-related signs and symptoms including itching, discoloration, bleeding, oozing, cracking, scaling, flaking, dry/rough, painful, burning, and stinging. Participants were asked to complete the self-administered sign and symptom severity diary containing NRS using a recall period of the past 24 hours. Question 1 of the diary was used to assess itch. Mean percent change in weekly average of daily itch/pruritus based on the NRS was presented using mean and SD from Baseline to Week 12. Baseline was defined as the latest assessment prior to first dose and Change from Baseline was defined as post-dose weekly average value minus Baseline value.

Outcome measures

Outcome measures
Measure	GSK2894512 0.5% QD n=41 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=42 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=40 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	GSK2894512 1% BID n=40 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=41 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=43 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
Mean Percent Change From Baseline in Weekly Average of Daily Itch/Pruritus NRS Score	-61.40 Percentage Change Standard Deviation 34.958	-29.16 Percentage Change Standard Deviation 55.251	-55.62 Percentage Change Standard Deviation 40.320	-64.69 Percentage Change Standard Deviation 36.916	-58.34 Percentage Change Standard Deviation 45.632	-60.39 Percentage Change Standard Deviation 44.314

SECONDARY outcome

Timeframe: Week 1, 2, 4, 8, 12, 14, 16, early withdrawal (EW) (up to Week 16)

Population: ITT Population

NRS is a 11-point tool ranging from 0 (absent) to 10 (worst imaginable) to assess the severity of 11 disease-related signs and symptoms including itching, discoloration, bleeding, oozing, cracking, scaling, flaking, dry/rough, painful, burning, and stinging. Participants were asked to complete the self-administered sign and symptom severity diary containing NRS using a recall period of the past 24 hours. Question 1 of the diary was used to assess itch. Percentage of participants who achieved a minimum 3-point improvement in itch/pruritus (NRS) from Baseline to each study visit were measured. Baseline was defined as the latest assessment prior to first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	GSK2894512 0.5% QD n=41 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=42 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=40 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	GSK2894512 1% BID n=40 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=41 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=43 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit Week 2; n= 28,30,36,30,26,23	33 Percentage of Participants	12 Percentage of Participants	22 Percentage of Participants	36 Percentage of Participants	33 Percentage of Participants	22 Percentage of Participants
Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit Week 8; n= 26,26,29,30,21,23	57 Percentage of Participants	29 Percentage of Participants	30 Percentage of Participants	46 Percentage of Participants	50 Percentage of Participants	48 Percentage of Participants
Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit Week 14; n= 21,20,19,20,17,14	50 Percentage of Participants	29 Percentage of Participants	50 Percentage of Participants	38 Percentage of Participants	40 Percentage of Participants	58 Percentage of Participants
Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit Week 16; n= 15,14,22,17,12,13	47 Percentage of Participants	17 Percentage of Participants	23 Percentage of Participants	33 Percentage of Participants	21 Percentage of Participants	41 Percentage of Participants
Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit EW; n= 0,3,2,2,5,6	50 Percentage of Participants	0 Percentage of Participants	17 Percentage of Participants	—	0 Percentage of Participants	50 Percentage of Participants
Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit Week 1; n= 29,35,33,31,24,25	16 Percentage of Participants	8 Percentage of Participants	12 Percentage of Participants	24 Percentage of Participants	9 Percentage of Participants	9 Percentage of Participants
Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit Week 4; n= 31,31,29,31,20,25	52 Percentage of Participants	35 Percentage of Participants	28 Percentage of Participants	42 Percentage of Participants	48 Percentage of Participants	45 Percentage of Participants
Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit Week 12; n= 22,25,23,23,14,16	52 Percentage of Participants	14 Percentage of Participants	38 Percentage of Participants	55 Percentage of Participants	52 Percentage of Participants	61 Percentage of Participants

SECONDARY outcome

Timeframe: Week 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)

Population: ITT Population

The EASI scoring system is a standard clinical tool for assessing the severity of AD that takes into account the overall severity of erythema, infiltration/papulation, excoriation, and lichenification, as well as the extent of BSA affected with AD. These 4 clinical signs were graded on a 4-point scale (0 \[absent\] to 3 \[severe\]) for each of the 4 specified body regions (head and neck, upper extremities, lower extremities, and trunk). Body area involvement ranged from 0 (0%) to 6 (90-100%). Total EASI score was calculated as a sum of scores of all 4 specified body region. Range for EASI total score is 0 (absent) to 72 (severe). Baseline was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Mean change from Baseline was presented in the form of mean and SD. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	GSK2894512 0.5% QD n=41 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=42 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=40 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	GSK2894512 1% BID n=40 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=41 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=43 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score Week 1; n= 38,41,39,37,38,32	-2.51 Scores on a scale Standard Deviation 3.240	-1.84 Scores on a scale Standard Deviation 2.730	-1.06 Scores on a scale Standard Deviation 3.660	-2.58 Scores on a scale Standard Deviation 3.965	-3.83 Scores on a scale Standard Deviation 4.410	-3.22 Scores on a scale Standard Deviation 3.585
Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score Week 8; n= 36,37,34,38,29,27	-7.62 Scores on a scale Standard Deviation 4.539	-5.24 Scores on a scale Standard Deviation 5.267	-4.15 Scores on a scale Standard Deviation 5.190	-7.00 Scores on a scale Standard Deviation 4.759	-8.12 Scores on a scale Standard Deviation 4.924	-8.67 Scores on a scale Standard Deviation 5.039
Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score Week 2; n= 39,39,39,39,33,32	-4.21 Scores on a scale Standard Deviation 3.337	-3.18 Scores on a scale Standard Deviation 3.545	-1.67 Scores on a scale Standard Deviation 3.079	-4.89 Scores on a scale Standard Deviation 4.052	-5.69 Scores on a scale Standard Deviation 3.996	-5.27 Scores on a scale Standard Deviation 3.848
Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score Week 4; n= 38,39,38,39,30,32	-6.19 Scores on a scale Standard Deviation 3.588	-4.45 Scores on a scale Standard Deviation 4.180	-2.94 Scores on a scale Standard Deviation 3.788	-6.55 Scores on a scale Standard Deviation 3.808	-7.18 Scores on a scale Standard Deviation 4.534	-7.42 Scores on a scale Standard Deviation 3.749
Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score Week 12; n= 36,37,32,35,28,25	-8.16 Scores on a scale Standard Deviation 5.077	-6.05 Scores on a scale Standard Deviation 5.937	-5.58 Scores on a scale Standard Deviation 5.668	-7.85 Scores on a scale Standard Deviation 5.000	-8.16 Scores on a scale Standard Deviation 4.931	-10.12 Scores on a scale Standard Deviation 4.665
Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score Week 14; n= 34,35,31,33,27,25	-7.42 Scores on a scale Standard Deviation 4.798	-6.28 Scores on a scale Standard Deviation 5.335	-5.44 Scores on a scale Standard Deviation 5.050	-7.08 Scores on a scale Standard Deviation 3.955	-7.36 Scores on a scale Standard Deviation 4.683	-9.07 Scores on a scale Standard Deviation 5.367
Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score Week 16; n= 34,36,31,35,27,25	-7.67 Scores on a scale Standard Deviation 4.405	-6.29 Scores on a scale Standard Deviation 6.158	-5.40 Scores on a scale Standard Deviation 5.315	-6.45 Scores on a scale Standard Deviation 4.245	-7.45 Scores on a scale Standard Deviation 5.106	-8.85 Scores on a scale Standard Deviation 5.654
Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score EW; n= 3,4,7,3,11,11	-2.97 Scores on a scale Standard Deviation 6.661	2.01 Scores on a scale Standard Deviation 4.418	3.38 Scores on a scale Standard Deviation 9.746	-1.03 Scores on a scale Standard Deviation 5.523	3.40 Scores on a scale Standard Deviation 4.023	3.11 Scores on a scale Standard Deviation 9.042

SECONDARY outcome

Timeframe: Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)

Population: ITT Population

The EASI scoring system is a standard clinical tool for assessing the severity of AD that takes into account the overall severity of erythema, infiltration/papulation, excoriation, and lichenification, as well as the extent of BSA affected with AD. These 4 clinical signs were graded on a 4-point scale (0 \[absent\] to 3 \[severe\]) for each of the 4 specified body regions (head and neck, upper extremities, lower extremities, and trunk). Body area involvement ranged from 0 (0%) to 6 (90-100%). Total EASI score was calculated as a sum of scores of all 4 specified body region. Range for EASI total score is 0 (absent) to 72 (severe). Baseline was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Mean percent change from Baseline was presented in the form of mean and SD. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	GSK2894512 0.5% QD n=41 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=42 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=40 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	GSK2894512 1% BID n=40 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=41 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=43 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
Mean Percent Change From Baseline in EASI Score Week 4; n= 38,39,38,39,30,32	-55.38 Percentage Change Standard Deviation 24.465	-40.74 Percentage Change Standard Deviation 30.097	-30.54 Percentage Change Standard Deviation 36.196	-64.95 Percentage Change Standard Deviation 23.948	-66.40 Percentage Change Standard Deviation 30.182	-60.07 Percentage Change Standard Deviation 23.967
Mean Percent Change From Baseline in EASI Score Week 14; n= 34,35,31,33,27,25	-64.72 Percentage Change Standard Deviation 25.594	-60.26 Percentage Change Standard Deviation 31.632	-55.21 Percentage Change Standard Deviation 31.514	-71.15 Percentage Change Standard Deviation 27.875	-65.53 Percentage Change Standard Deviation 29.777	-70.37 Percentage Change Standard Deviation 31.907
Mean Percent Change From Baseline in EASI Score Week 16; n= 34,36,31,35,27,25	-67.28 Percentage Change Standard Deviation 25.745	-57.52 Percentage Change Standard Deviation 47.140	-52.47 Percentage Change Standard Deviation 38.236	-63.59 Percentage Change Standard Deviation 36.461	-63.70 Percentage Change Standard Deviation 25.833	-69.89 Percentage Change Standard Deviation 32.687
Mean Percent Change From Baseline in EASI Score EW; n= 3,4,7,3,11,11	-35.40 Percentage Change Standard Deviation 66.349	13.69 Percentage Change Standard Deviation 32.424	32.55 Percentage Change Standard Deviation 86.387	-0.83 Percentage Change Standard Deviation 98.753	42.27 Percentage Change Standard Deviation 43.950	8.74 Percentage Change Standard Deviation 87.714
Mean Percent Change From Baseline in EASI Score Week 1; n= 38,41,39,37,38,32	-25.81 Percentage Change Standard Deviation 28.724	-16.79 Percentage Change Standard Deviation 25.777	-7.51 Percentage Change Standard Deviation 36.549	-23.83 Percentage Change Standard Deviation 42.885	-34.76 Percentage Change Standard Deviation 32.718	-24.19 Percentage Change Standard Deviation 21.716
Mean Percent Change From Baseline in EASI Score Week 2; n= 39,39,39,39,33,32	-40.41 Percentage Change Standard Deviation 30.835	-32.03 Percentage Change Standard Deviation 32.737	-13.98 Percentage Change Standard Deviation 38.616	-48.70 Percentage Change Standard Deviation 33.089	-54.21 Percentage Change Standard Deviation 29.107	-42.60 Percentage Change Standard Deviation 26.428
Mean Percent Change From Baseline in EASI Score Week 8; n= 36,37,34,38,29,27	-65.12 Percentage Change Standard Deviation 26.089	-50.78 Percentage Change Standard Deviation 33.026	-43.15 Percentage Change Standard Deviation 41.388	-68.14 Percentage Change Standard Deviation 28.052	-73.57 Percentage Change Standard Deviation 27.204	-70.52 Percentage Change Standard Deviation 25.062
Mean Percent Change From Baseline in EASI Score Week 12; n= 36,37,32,35,28,25	-69.49 Percentage Change Standard Deviation 24.805	-56.73 Percentage Change Standard Deviation 38.234	-60.29 Percentage Change Standard Deviation 34.253	-77.19 Percentage Change Standard Deviation 28.152	-73.02 Percentage Change Standard Deviation 25.068	-80.13 Percentage Change Standard Deviation 18.602

SECONDARY outcome

Timeframe: Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)

Population: ITT Population

The IGA is a clinical tool for assessing the current state/severity of a participant's AD. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines. IGA is made without reference to previous scores. The percentage of participants with a minimum 2-grade improvement in IGA score from Baseline at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and early withdrawal (EW) visit was presented in the form of mean and SD. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	GSK2894512 0.5% QD n=41 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=42 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=40 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	GSK2894512 1% BID n=40 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=41 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=43 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit Week 1; n= 38,41,39,37,38,32	3 Percentage of participants	5 Percentage of participants	6 Percentage of participants	5 Percentage of participants	7 Percentage of participants	0 Percentage of participants
Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit Week 2; n= 39, 39, 39, 39, 33, 32	15 Percentage of participants	15 Percentage of participants	9 Percentage of participants	18 Percentage of participants	21 Percentage of participants	10 Percentage of participants
Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit Week 4; n= 38,39,38,39,30,32	28 Percentage of participants	23 Percentage of participants	13 Percentage of participants	32 Percentage of participants	46 Percentage of participants	26 Percentage of participants
Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit Week 8; n= 36,37,34,38,29,27	45 Percentage of participants	28 Percentage of participants	22 Percentage of participants	44 Percentage of participants	59 Percentage of participants	38 Percentage of participants
Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit Week 12; n= 36,37,32,35,28,25	43 Percentage of participants	39 Percentage of participants	44 Percentage of participants	64 Percentage of participants	51 Percentage of participants	53 Percentage of participants
Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit Week 14; n= 34,35,31,33,27,25	42 Percentage of participants	26 Percentage of participants	36 Percentage of participants	47 Percentage of participants	46 Percentage of participants	55 Percentage of participants
Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit Week 16; n= 34,36,31,35,27,25	43 Percentage of participants	33 Percentage of participants	32 Percentage of participants	35 Percentage of participants	36 Percentage of participants	39 Percentage of participants
Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit EW; n= 3,4,7,3,11,11	33 Percentage of participants	0 Percentage of participants	9 Percentage of participants	33 Percentage of participants	0 Percentage of participants	14 Percentage of participants

SECONDARY outcome

Timeframe: Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)

Population: ITT Population

The IGA is a clinical tool for assessing the current state/severity of a participant's AD. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines. IGA is made without reference to previous scores. The percentage of participants with an IGA score of 0 or 1 at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW visit was presented in the form of mean and SD. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	GSK2894512 0.5% QD n=41 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=42 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=40 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	GSK2894512 1% BID n=40 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=41 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=43 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
Percentage of Participants With an IGA Score of 0 or 1 at Each Visit EW; n= 3,4,7,3,11,11	33 Percentage of participants	0 Percentage of participants	9 Percentage of participants	33 Percentage of participants	0 Percentage of participants	14 Percentage of participants
Percentage of Participants With an IGA Score of 0 or 1 at Each Visit Week 1; 38,41,39,37,38,32	3 Percentage of participants	3 Percentage of participants	3 Percentage of participants	5 Percentage of participants	5 Percentage of participants	0 Percentage of participants
Percentage of Participants With an IGA Score of 0 or 1 at Each Visit Week 2; n= 39,39,39,39,33,32	13 Percentage of participants	15 Percentage of participants	9 Percentage of participants	18 Percentage of participants	18 Percentage of participants	10 Percentage of participants
Percentage of Participants With an IGA Score of 0 or 1 at Each Visit Week 4; n= 38,39,38,39,30,32	23 Percentage of participants	20 Percentage of participants	9 Percentage of participants	32 Percentage of participants	38 Percentage of participants	26 Percentage of participants
Percentage of Participants With an IGA Score of 0 or 1 at Each Visit Week 8; n= 36,37,34,38,29,27	42 Percentage of participants	28 Percentage of participants	19 Percentage of participants	42 Percentage of participants	54 Percentage of participants	38 Percentage of participants
Percentage of Participants With an IGA Score of 0 or 1 at Each Visit Week 12; n= 36,37,32,35,28,25	40 Percentage of participants	36 Percentage of participants	44 Percentage of participants	58 Percentage of participants	51 Percentage of participants	50 Percentage of participants
Percentage of Participants With an IGA Score of 0 or 1 at Each Visit Week 14; n= 34,35,31,33,27,25	36 Percentage of participants	26 Percentage of participants	36 Percentage of participants	44 Percentage of participants	43 Percentage of participants	52 Percentage of participants
Percentage of Participants With an IGA Score of 0 or 1 at Each Visit Week 16; n= 34,36,31,35,27,25	40 Percentage of participants	30 Percentage of participants	28 Percentage of participants	35 Percentage of participants	36 Percentage of participants	39 Percentage of participants

SECONDARY outcome

Timeframe: Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)

Population: ITT Population

The EASI scoring system is a standard clinical tool for assessing the severity of AD that takes into account the overall severity of erythema, infiltration/papulation, excoriation, and lichenification, as well as the extent of BSA affected with AD. These 4 clinical signs were graded on a 4-point scale for each of the 4 specified body regions (head and neck, upper extremities, lower extremities, and trunk). Percentage of participants with \>=50 percent improvement in EASI score from Baseline to Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW were presented and statistical analysis was performed using a repeated measures factorial logistic regression model. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	GSK2894512 0.5% QD n=41 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=42 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=40 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	GSK2894512 1% BID n=40 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=41 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=43 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
Percentage of Participants With >=50 Percent Improvement From Baseline in EASI Week 1; n= 38, 41, 39, 37, 38, 32	22 Percentage of participants	11 Percentage of participants	13 Percentage of participants	32 Percentage of participants	39 Percentage of participants	13 Percentage of participants
Percentage of Participants With >=50 Percent Improvement From Baseline in EASI Week 2; n= 39, 39, 39, 39, 33, 32	36 Percentage of participants	33 Percentage of participants	19 Percentage of participants	56 Percentage of participants	56 Percentage of participants	38 Percentage of participants
Percentage of Participants With >=50 Percent Improvement From Baseline in EASI Week 4; n= 38, 39, 38, 39, 30, 32	59 Percentage of participants	37 Percentage of participants	41 Percentage of participants	76 Percentage of participants	72 Percentage of participants	63 Percentage of participants
Percentage of Participants With >=50 Percent Improvement From Baseline in EASI Week 8; n= 36, 37, 34, 38, 29, 27	79 Percentage of participants	59 Percentage of participants	56 Percentage of participants	81 Percentage of participants	92 Percentage of participants	85 Percentage of participants
Percentage of Participants With >=50 Percent Improvement From Baseline in EASI Week 12; n= 36, 37, 32, 35, 28, 25	74 Percentage of participants	64 Percentage of participants	84 Percentage of participants	83 Percentage of participants	84 Percentage of participants	97 Percentage of participants
Percentage of Participants With >=50 Percent Improvement From Baseline in EASI Week 14; n= 34, 35, 31, 33, 27, 25	76 Percentage of participants	63 Percentage of participants	68 Percentage of participants	85 Percentage of participants	74 Percentage of participants	81 Percentage of participants
Percentage of Participants With >=50 Percent Improvement From Baseline in EASI Week 16; n= 34, 36, 31 35, 27, 25	71 Percentage of participants	67 Percentage of participants	72 Percentage of participants	76 Percentage of participants	78 Percentage of participants	84 Percentage of participants
Percentage of Participants With >=50 Percent Improvement From Baseline in EASI EW; n= 3,4,7,3,11,11	33 Percentage of participants	0 Percentage of participants	9 Percentage of participants	33 Percentage of participants	0 Percentage of participants	29 Percentage of participants

SECONDARY outcome

Timeframe: Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)

Population: ITT Population

The EASI scoring system is a standard clinical tool for assessing the severity of AD that takes into account the overall severity of erythema, infiltration/papulation, excoriation, and lichenification, as well as the extent of BSA affected with AD. These 4 clinical signs were graded on a 4-point scale for each of the 4 specified body regions (head and neck, upper extremities, lower extremities, and trunk). Percentage of participants with \>=75 percent improvement in EASI score from Baseline to Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW were presented and statistical analysis was performed using a repeated measures factorial logistic regression model. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	GSK2894512 0.5% QD n=41 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=42 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=40 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	GSK2894512 1% BID n=40 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=41 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=43 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
Percentage of Participants With >=75 Percent Improvement From Baseline in EASI Week 1; n= 38, 41, 39, 37, 38, 32	5 Percentage of participants	0 Percentage of participants	6 Percentage of participants	5 Percentage of participants	12 Percentage of participants	0 Percentage of participants
Percentage of Participants With >=75 Percent Improvement From Baseline in EASI Week 2; n= 39, 39, 39, 39, 33, 32	21 Percentage of participants	9 Percentage of participants	3 Percentage of participants	21 Percentage of participants	33 Percentage of participants	13 Percentage of participants
Percentage of Participants With >=75 Percent Improvement From Baseline in EASI Week 4; n= 38, 39, 38, 39, 30, 32	26 Percentage of participants	20 Percentage of participants	9 Percentage of participants	37 Percentage of participants	51 Percentage of participants	29 Percentage of participants
Percentage of Participants With >=75 Percent Improvement From Baseline in EASI Week 8; n= 36, 37, 34, 38, 29, 27	37 Percentage of participants	31 Percentage of participants	26 Percentage of participants	44 Percentage of participants	57 Percentage of participants	53 Percentage of participants
Percentage of Participants With >=75 Percent Improvement From Baseline in EASI Week 12; n= 36, 37, 32, 35, 28, 25	46 Percentage of participants	39 Percentage of participants	40 Percentage of participants	67 Percentage of participants	57 Percentage of participants	69 Percentage of participants
Percentage of Participants With >=75 Percent Improvement From Baseline in EASI Week 14; n= 34, 35, 31, 33, 27, 25	36 Percentage of participants	41 Percentage of participants	36 Percentage of participants	50 Percentage of participants	49 Percentage of participants	68 Percentage of participants
Percentage of Participants With >=75 Percent Improvement From Baseline in EASI Week 16; n= 34, 36, 31 35, 27, 25	43 Percentage of participants	44 Percentage of participants	32 Percentage of participants	47 Percentage of participants	39 Percentage of participants	61 Percentage of participants
Percentage of Participants With >=75 Percent Improvement From Baseline in EASI EW; n= 3,4,7,3,11,11	33 Percentage of participants	0 Percentage of participants	9 Percentage of participants	33 Percentage of participants	0 Percentage of participants	14 Percentage of participants

SECONDARY outcome

Timeframe: Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)

Population: ITT Population

A target lesion of at least 3 centimeter square (cm\^2) was selected at Baseline. The severity of the following signs: erythema, induration/papulation, lichenification, oozing/crusting, and scaling was assessed on a 4-point scale ranging from 0 (absent) to 3 (severe), with higher values indicating greater severity of symptoms. TSS (maximum score 15) was calculated based on these signs. Mean change from Baseline in TSS at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW visit was presented using mean and SD. Baseline value was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	GSK2894512 0.5% QD n=41 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=42 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=40 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	GSK2894512 1% BID n=40 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=41 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=43 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
Mean Change From Baseline in Total Severity Score (TSS) Week 1; n= 38, 41, 39, 37, 38, 32	-1.8 Scores on a scale Standard Deviation 2.02	-1.9 Scores on a scale Standard Deviation 2.60	-0.9 Scores on a scale Standard Deviation 2.21	-1.8 Scores on a scale Standard Deviation 2.04	-2.7 Scores on a scale Standard Deviation 2.75	-2.1 Scores on a scale Standard Deviation 1.81
Mean Change From Baseline in Total Severity Score (TSS) Week 2; n= 39, 39, 39, 39, 33, 32	-3.3 Scores on a scale Standard Deviation 2.46	-3.1 Scores on a scale Standard Deviation 2.73	-1.8 Scores on a scale Standard Deviation 2.73	-3.6 Scores on a scale Standard Deviation 2.50	-4.0 Scores on a scale Standard Deviation 2.42	-3.7 Scores on a scale Standard Deviation 2.45
Mean Change From Baseline in Total Severity Score (TSS) Week 4; n= 38, 39, 38, 39, 30, 32	-4.1 Scores on a scale Standard Deviation 2.64	-3.3 Scores on a scale Standard Deviation 2.68	-3.0 Scores on a scale Standard Deviation 3.03	-4.2 Scores on a scale Standard Deviation 2.48	-4.5 Scores on a scale Standard Deviation 2.39	-5.1 Scores on a scale Standard Deviation 2.58
Mean Change From Baseline in Total Severity Score (TSS) Week 8; n= 36, 37, 34, 38, 29, 27	-5.1 Scores on a scale Standard Deviation 2.34	-4.7 Scores on a scale Standard Deviation 2.68	-4.3 Scores on a scale Standard Deviation 3.01	-4.7 Scores on a scale Standard Deviation 2.37	-5.4 Scores on a scale Standard Deviation 2.65	-6.1 Scores on a scale Standard Deviation 2.17
Mean Change From Baseline in Total Severity Score (TSS) Week 12; n= 36, 37, 32, 35, 28, 25	-5.5 Scores on a scale Standard Deviation 2.58	-4.6 Scores on a scale Standard Deviation 2.64	-5.2 Scores on a scale Standard Deviation 2.97	-5.8 Scores on a scale Standard Deviation 2.92	-5.5 Scores on a scale Standard Deviation 2.64	-7.0 Scores on a scale Standard Deviation 2.38
Mean Change From Baseline in Total Severity Score (TSS) Week 14; n= 34, 35, 31, 33, 27, 25	-4.4 Scores on a scale Standard Deviation 3.09	-5.0 Scores on a scale Standard Deviation 2.72	-5.0 Scores on a scale Standard Deviation 2.88	-5.6 Scores on a scale Standard Deviation 2.67	-5.1 Scores on a scale Standard Deviation 2.19	-5.5 Scores on a scale Standard Deviation 3.22
Mean Change From Baseline in Total Severity Score (TSS) Week 16; n= 34, 36, 31, 35, 27, 25	-5.1 Scores on a scale Standard Deviation 2.65	-4.8 Scores on a scale Standard Deviation 2.62	-4.9 Scores on a scale Standard Deviation 2.74	-5.4 Scores on a scale Standard Deviation 2.98	-4.9 Scores on a scale Standard Deviation 2.27	-6.0 Scores on a scale Standard Deviation 2.91
Mean Change From Baseline in Total Severity Score (TSS) EW; n= 3, 4, 7, 3, 11, 11	-2.7 Scores on a scale Standard Deviation 3.51	-1.1 Scores on a scale Standard Deviation 3.65	-0.1 Scores on a scale Standard Deviation 4.04	-2.3 Scores on a scale Standard Deviation 4.93	0.5 Scores on a scale Standard Deviation 5.26	-0.4 Scores on a scale Standard Deviation 4.83

SECONDARY outcome

Timeframe: Week 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)

Population: ITT Population

A target lesion of at least 3 cm\^2 was selected at Baseline. The severity of the following signs: erythema, induration/papulation, lichenification, oozing/crusting, and scaling was assessed on a 4-point scale ranging from 0 (absent) to 3 (severe) , with higher values indicating greater severity of symptoms. TSS (maximum score 15) was calculated based on these signs. Mean percent change from Baseline in TSS at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW visit was presented using mean and SD. Baseline value was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	GSK2894512 0.5% QD n=41 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=42 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=40 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	GSK2894512 1% BID n=40 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=41 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=43 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
Mean Percent Change From Baseline in TSS Week 4; n= 38, 39, 38, 39, 30, 32	-52.1 Percentage Change Standard Deviation 33.85	-37.4 Percentage Change Standard Deviation 27.29	-33.5 Percentage Change Standard Deviation 36.16	-55.8 Percentage Change Standard Deviation 31.18	-60.1 Percentage Change Standard Deviation 28.58	-60.3 Percentage Change Standard Deviation 27.68
Mean Percent Change From Baseline in TSS Week 1; n= 38, 41, 39, 37, 38, 32	-22.6 Percentage Change Standard Deviation 24.78	-22.0 Percentage Change Standard Deviation 27.47	-9.8 Percentage Change Standard Deviation 28.06	-23.5 Percentage Change Standard Deviation 27.99	-33.7 Percentage Change Standard Deviation 31.01	-25.8 Percentage Change Standard Deviation 21.94
Mean Percent Change From Baseline in TSS Week 2; n= 39, 39, 39, 39, 33, 32	-42.4 Percentage Change Standard Deviation 33.54	-35.1 Percentage Change Standard Deviation 29.29	-17.6 Percentage Change Standard Deviation 40.06	-46.7 Percentage Change Standard Deviation 32.75	-52.8 Percentage Change Standard Deviation 28.45	-44.5 Percentage Change Standard Deviation 26.15
Mean Percent Change From Baseline in TSS Week 8; n= 36, 37, 34, 38, 29, 27	-65.3 Percentage Change Standard Deviation 28.31	-57.4 Percentage Change Standard Deviation 31.55	-50.0 Percentage Change Standard Deviation 35.53	-61.7 Percentage Change Standard Deviation 28.14	-69.1 Percentage Change Standard Deviation 27.56	-71.0 Percentage Change Standard Deviation 20.75
Mean Percent Change From Baseline in TSS Week 12; n= 36, 37, 32, 35, 28, 25	-68.6 Percentage Change Standard Deviation 27.17	-56.2 Percentage Change Standard Deviation 30.53	-62.6 Percentage Change Standard Deviation 30.39	-74.3 Percentage Change Standard Deviation 31.61	-73.1 Percentage Change Standard Deviation 31.69	-80.9 Percentage Change Standard Deviation 18.59
Mean Percent Change From Baseline in TSS Week 14; n= 34, 35, 31, 33, 27, 25	-53.7 Percentage Change Standard Deviation 35.25	-59.7 Percentage Change Standard Deviation 34.87	-60.2 Percentage Change Standard Deviation 29.97	-73.5 Percentage Change Standard Deviation 30.31	-71.1 Percentage Change Standard Deviation 29.53	-63.0 Percentage Change Standard Deviation 32.96
Mean Percent Change From Baseline in TSS Week 16; n= 34, 36, 31, 35, 27, 25	-63.5 Percentage Change Standard Deviation 29.78	-59.8 Percentage Change Standard Deviation 33.68	-60.3 Percentage Change Standard Deviation 31.16	-69.3 Percentage Change Standard Deviation 33.20	-66.0 Percentage Change Standard Deviation 30.03	-68.8 Percentage Change Standard Deviation 30.66
Mean Percent Change From Baseline in TSS EW; n= 3, 4, 7, 3, 11, 11	-40.3 Percentage Change Standard Deviation 56.57	-7.9 Percentage Change Standard Deviation 41.91	5.0 Percentage Change Standard Deviation 59.63	-26.7 Percentage Change Standard Deviation 64.29	1.4 Percentage Change Standard Deviation 82.20	-2.9 Percentage Change Standard Deviation 75.44

SECONDARY outcome

Timeframe: Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)

Population: ITT Population

The severity of the following signs: erythema, induration/papulation, lichenification, oozing/crusting, and scaling was assessed on a 4-point scale ranging from 0 (absent) to 3 (severe) and TSS (maximum score 15) was calculated based on these signs. Mean change from Baseline in individual signs of TSS was presented using mean and SD. Baseline value was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. If the participant had more than 3 missing days during the week, then the weekly average was not calculated and treated as missing data and excluded from the analysis. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	GSK2894512 0.5% QD n=41 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=42 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=40 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	GSK2894512 1% BID n=40 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=41 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=43 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
Mean Change From Baseline in Individual Signs of TSS Scaling; Week 2;n= 39,39,39,39,33,32	-0.6 Scores on a scale Standard Deviation 0.71	-0.6 Scores on a scale Standard Deviation 0.78	-0.3 Scores on a scale Standard Deviation 0.63	-0.6 Scores on a scale Standard Deviation 0.82	-0.7 Scores on a scale Standard Deviation 0.68	-0.6 Scores on a scale Standard Deviation 0.67
Mean Change From Baseline in Individual Signs of TSS Scaling; Week 1;n=38,41,39,37,38,32	-0.3 Scores on a scale Standard Deviation 0.78	-0.4 Scores on a scale Standard Deviation 0.72	-0.2 Scores on a scale Standard Deviation 0.63	-0.3 Scores on a scale Standard Deviation 0.85	-0.4 Scores on a scale Standard Deviation 0.70	-0.4 Scores on a scale Standard Deviation 0.68
Mean Change From Baseline in Individual Signs of TSS Erythema; Week 1; n= 38, 41, 39, 37, 38, 32	-0.4 Scores on a scale Standard Deviation 0.55	-0.4 Scores on a scale Standard Deviation 0.76	-0.2 Scores on a scale Standard Deviation 0.66	-0.6 Scores on a scale Standard Deviation 0.55	-0.8 Scores on a scale Standard Deviation 0.88	-0.4 Scores on a scale Standard Deviation 0.63
Mean Change From Baseline in Individual Signs of TSS Erythema; Week 2; n= 39, 39, 39, 39, 33, 32	-0.7 Scores on a scale Standard Deviation 0.75	-0.6 Scores on a scale Standard Deviation 0.78	-0.3 Scores on a scale Standard Deviation 0.93	-1.1 Scores on a scale Standard Deviation 0.70	-1.1 Scores on a scale Standard Deviation 0.84	-0.8 Scores on a scale Standard Deviation 0.76
Mean Change From Baseline in Individual Signs of TSS Erythema; Week 4; n= 38, 39, 38, 39, 30, 32	-0.9 Scores on a scale Standard Deviation 0.79	-0.8 Scores on a scale Standard Deviation 0.73	-0.6 Scores on a scale Standard Deviation 0.87	-1.1 Scores on a scale Standard Deviation 0.69	-1.3 Scores on a scale Standard Deviation 0.75	-1.2 Scores on a scale Standard Deviation 0.79
Mean Change From Baseline in Individual Signs of TSS Erythema; Week 8; n= 36, 37, 34, 38, 29, 27	-1.2 Scores on a scale Standard Deviation 0.73	-1.2 Scores on a scale Standard Deviation 0.85	-0.9 Scores on a scale Standard Deviation 1.01	-1.3 Scores on a scale Standard Deviation 0.70	-1.5 Scores on a scale Standard Deviation 0.77	-1.4 Scores on a scale Standard Deviation 0.61
Mean Change From Baseline in Individual Signs of TSS Erythema; Week 12; n= 36, 37, 32, 35, 28, 25	-1.3 Scores on a scale Standard Deviation 0.84	-1.1 Scores on a scale Standard Deviation 0.77	-1.0 Scores on a scale Standard Deviation 0.89	-1.5 Scores on a scale Standard Deviation 0.84	-1.5 Scores on a scale Standard Deviation 0.80	-1.7 Scores on a scale Standard Deviation 0.69
Mean Change From Baseline in Individual Signs of TSS Erythema; Week 14; n= 34, 35, 31, 33, 27, 25	-1.0 Scores on a scale Standard Deviation 0.75	-1.2 Scores on a scale Standard Deviation 0.74	-1.0 Scores on a scale Standard Deviation 0.79	-1.5 Scores on a scale Standard Deviation 0.83	-1.4 Scores on a scale Standard Deviation 0.77	-1.3 Scores on a scale Standard Deviation 0.97
Mean Change From Baseline in Individual Signs of TSS Erythema; Week 16; n= 34, 36 , 31, 35, 27, 25	-1.1 Scores on a scale Standard Deviation 0.77	-1.1 Scores on a scale Standard Deviation 0.87	-1.0 Scores on a scale Standard Deviation 0.68	-1.5 Scores on a scale Standard Deviation 0.83	-1.3 Scores on a scale Standard Deviation 0.82	-1.4 Scores on a scale Standard Deviation 0.92
Mean Change From Baseline in Individual Signs of TSS Erythema; EW; n= 3, 4, 7, 3, 11, 11	-1.0 Scores on a scale Standard Deviation 1.00	-0.4 Scores on a scale Standard Deviation 1.12	-0.1 Scores on a scale Standard Deviation 1.38	-0.7 Scores on a scale Standard Deviation 1.15	-0.3 Scores on a scale Standard Deviation 0.96	-0.4 Scores on a scale Standard Deviation 0.98
Mean Change From Baseline in Individual Signs of TSS Induration/Papulation;Week 1; n=38,41,39,37,38,32	-0.4 Scores on a scale Standard Deviation 0.60	-0.3 Scores on a scale Standard Deviation 0.65	-0.1 Scores on a scale Standard Deviation 0.55	-0.3 Scores on a scale Standard Deviation 0.48	-0.6 Scores on a scale Standard Deviation 0.77	-0.5 Scores on a scale Standard Deviation 0.68
Mean Change From Baseline in Individual Signs of TSS Induration/Papulation;Week 2;n= 39,39,39,39,33,32	-0.8 Scores on a scale Standard Deviation 0.73	-0.6 Scores on a scale Standard Deviation 0.87	-0.4 Scores on a scale Standard Deviation 0.87	-0.8 Scores on a scale Standard Deviation 0.73	-1.0 Scores on a scale Standard Deviation 0.87	-0.8 Scores on a scale Standard Deviation 0.84
Mean Change From Baseline in Individual Signs of TSS Induration/Papulation;Week 4;n= 38,39,38,39,30,32	-0.9 Scores on a scale Standard Deviation 0.83	-0.7 Scores on a scale Standard Deviation 0.75	-0.7 Scores on a scale Standard Deviation 0.79	-1.0 Scores on a scale Standard Deviation 0.82	-1.2 Scores on a scale Standard Deviation 0.86	-1.1 Scores on a scale Standard Deviation 0.78
Mean Change From Baseline in Individual Signs of TSS Induration/Papulation;Week 8;n= 36,37,34,38,29,27	-1.2 Scores on a scale Standard Deviation 0.69	-1.0 Scores on a scale Standard Deviation 0.76	-0.9 Scores on a scale Standard Deviation 0.75	-1.1 Scores on a scale Standard Deviation 0.65	-1.2 Scores on a scale Standard Deviation 1.00	-1.4 Scores on a scale Standard Deviation 0.66
Mean Change From Baseline in Individual Signs of TSS Induration/Papulation;Week 12;n=36,37,32,35,28,25	-1.2 Scores on a scale Standard Deviation 0.73	-0.8 Scores on a scale Standard Deviation 0.79	-1.1 Scores on a scale Standard Deviation 0.86	-1.4 Scores on a scale Standard Deviation 0.87	-1.4 Scores on a scale Standard Deviation 0.86	-1.6 Scores on a scale Standard Deviation 0.72
Mean Change From Baseline in Individual Signs of TSS Induration/Papulation;Week 14;n=34,35,31,33,27,25	-0.9 Scores on a scale Standard Deviation 0.83	-0.9 Scores on a scale Standard Deviation 0.75	-1.1 Scores on a scale Standard Deviation 0.83	-1.3 Scores on a scale Standard Deviation 0.86	-1.3 Scores on a scale Standard Deviation 0.64	-1.3 Scores on a scale Standard Deviation 0.73
Mean Change From Baseline in Individual Signs of TSS Induration/Papulation;Week 16;n=34,36,31,35,27,25	-1.2 Scores on a scale Standard Deviation 0.82	-0.8 Scores on a scale Standard Deviation 0.68	-1.1 Scores on a scale Standard Deviation 0.91	-1.2 Scores on a scale Standard Deviation 0.82	-1.2 Scores on a scale Standard Deviation 0.74	-1.4 Scores on a scale Standard Deviation 0.75
Mean Change From Baseline in Individual Signs of TSS Induration/Papulation; EW; n= 3,4,7,3,11,11	0.0 Scores on a scale Standard Deviation 1.00	-0.3 Scores on a scale Standard Deviation 1.19	0.1 Scores on a scale Standard Deviation 1.38	-0.3 Scores on a scale Standard Deviation 1.53	0.0 Scores on a scale Standard Deviation 0.82	-0.1 Scores on a scale Standard Deviation 1.35
Mean Change From Baseline in Individual Signs of TSS Lichenification; Week 1;n=38,41,39,37,38,32	-0.4 Scores on a scale Standard Deviation 0.54	-0.4 Scores on a scale Standard Deviation 0.63	-0.2 Scores on a scale Standard Deviation 0.42	-0.3 Scores on a scale Standard Deviation 0.63	-0.5 Scores on a scale Standard Deviation 0.81	-0.4 Scores on a scale Standard Deviation 0.60
Mean Change From Baseline in Individual Signs of TSS Lichenification; Week 2;n=39,39,39,39,33,32	-0.7 Scores on a scale Standard Deviation 0.73	-0.7 Scores on a scale Standard Deviation 0.78	-0.4 Scores on a scale Standard Deviation 0.76	-0.6 Scores on a scale Standard Deviation 0.81	-0.8 Scores on a scale Standard Deviation 0.78	-0.7 Scores on a scale Standard Deviation 0.66
Mean Change From Baseline in Individual Signs of TSS Lichenification; Week 4;n=38,39,38,39,30,32	-0.9 Scores on a scale Standard Deviation 0.84	-0.6 Scores on a scale Standard Deviation 0.89	-0.6 Scores on a scale Standard Deviation 0.88	-0.8 Scores on a scale Standard Deviation 0.81	-0.9 Scores on a scale Standard Deviation 0.70	-1.1 Scores on a scale Standard Deviation 0.73
Mean Change From Baseline in Individual Signs of TSS Lichenification; Week 8;n=36,37,34,38,29,27	-1.1 Scores on a scale Standard Deviation 0.74	-0.9 Scores on a scale Standard Deviation 0.65	-1.0 Scores on a scale Standard Deviation 0.76	-0.9 Scores on a scale Standard Deviation 0.83	-1.1 Scores on a scale Standard Deviation 0.80	-1.2 Scores on a scale Standard Deviation 0.67
Mean Change From Baseline in Individual Signs of TSS Lichenification; Week 12;n=36,37,32,35,28,25	-1.2 Scores on a scale Standard Deviation 0.75	-1.0 Scores on a scale Standard Deviation 0.67	-1.3 Scores on a scale Standard Deviation 0.74	-1.2 Scores on a scale Standard Deviation 0.91	-1.1 Scores on a scale Standard Deviation 0.75	-1.5 Scores on a scale Standard Deviation 0.57
Mean Change From Baseline in Individual Signs of TSS Lichenification; Week 14;n=34,35,31,33,27,25	-1.1 Scores on a scale Standard Deviation 0.70	-1.0 Scores on a scale Standard Deviation 0.85	-1.2 Scores on a scale Standard Deviation 0.82	-1.2 Scores on a scale Standard Deviation 0.84	-1.0 Scores on a scale Standard Deviation 0.71	-1.2 Scores on a scale Standard Deviation 0.83
Mean Change From Baseline in Individual Signs of TSS Lichenification; Week 16;n=34,36,31,35,27,25	-1.1 Scores on a scale Standard Deviation 0.72	-1.0 Scores on a scale Standard Deviation 0.76	-1.2 Scores on a scale Standard Deviation 0.65	-1.1 Scores on a scale Standard Deviation 0.98	-1.0 Scores on a scale Standard Deviation 0.70	-1.3 Scores on a scale Standard Deviation 0.73
Mean Change From Baseline in Individual Signs of TSS Lichenification; EW;n= 3,4,7,3,11,11	-1.0 Scores on a scale Standard Deviation 1.00	-0.4 Scores on a scale Standard Deviation 0.81	-0.2 Scores on a scale Standard Deviation 0.98	-0.7 Scores on a scale Standard Deviation 1.15	0.0 Scores on a scale Standard Deviation 0.82	-0.4 Scores on a scale Standard Deviation 0.98
Mean Change From Baseline in Individual Signs of TSS Oozing/crusting; Week 1;n=38,41,39,37,38,32	-0.3 Scores on a scale Standard Deviation 0.47	-0.3 Scores on a scale Standard Deviation 0.91	-0.2 Scores on a scale Standard Deviation 0.68	-0.2 Scores on a scale Standard Deviation 0.47	-0.4 Scores on a scale Standard Deviation 0.62	-0.4 Scores on a scale Standard Deviation 0.63
Mean Change From Baseline in Individual Signs of TSS Oozing/crusting; Week 2;n=39,39,39,39,33,32	-0.4 Scores on a scale Standard Deviation 0.55	-0.5 Scores on a scale Standard Deviation 0.75	-0.4 Scores on a scale Standard Deviation 0.66	-0.5 Scores on a scale Standard Deviation 0.60	-0.4 Scores on a scale Standard Deviation 0.55	-0.7 Scores on a scale Standard Deviation 0.79
Mean Change From Baseline in Individual Signs of TSS Oozing/crusting; Week 4;n=38,39,38,39,30,32	-0.6 Scores on a scale Standard Deviation 0.67	-0.6 Scores on a scale Standard Deviation 0.82	-0.5 Scores on a scale Standard Deviation 0.80	-0.6 Scores on a scale Standard Deviation 0.65	-0.5 Scores on a scale Standard Deviation 0.64	-0.8 Scores on a scale Standard Deviation 0.86
Mean Change From Baseline in Individual Signs of TSS Oozing/crusting; Week 8;n=36,37,34,38,29,27	-0.7 Scores on a scale Standard Deviation 0.65	-0.6 Scores on a scale Standard Deviation 0.78	-0.7 Scores on a scale Standard Deviation 0.82	-0.6 Scores on a scale Standard Deviation 0.64	-0.6 Scores on a scale Standard Deviation 0.75	-1.0 Scores on a scale Standard Deviation 0.90
Mean Change From Baseline in Individual Signs of TSS Oozing/crusting; Week 12;n=36,37,32,35,28,25	-0.7 Scores on a scale Standard Deviation 0.66	-0.7 Scores on a scale Standard Deviation 0.81	-0.8 Scores on a scale Standard Deviation 0.94	-0.6 Scores on a scale Standard Deviation 0.60	-0.6 Scores on a scale Standard Deviation 0.72	-1.1 Scores on a scale Standard Deviation 0.93
Mean Change From Baseline in Individual Signs of TSS Oozing/crusting; Week 14;n=34,35,31,33,27,25	-0.5 Scores on a scale Standard Deviation 0.94	-0.8 Scores on a scale Standard Deviation 0.79	-0.9 Scores on a scale Standard Deviation 0.83	-0.6 Scores on a scale Standard Deviation 0.65	-0.5 Scores on a scale Standard Deviation 0.78	-0.8 Scores on a scale Standard Deviation 1.00
Mean Change From Baseline in Individual Signs of TSS Oozing/crusting; Week 16;n=34,36,31,35,27,25	-0.7 Scores on a scale Standard Deviation 0.62	-0.8 Scores on a scale Standard Deviation 0.75	-0.8 Scores on a scale Standard Deviation 0.87	-0.6 Scores on a scale Standard Deviation 0.61	-0.6 Scores on a scale Standard Deviation 0.77	-1.0 Scores on a scale Standard Deviation 1.03
Mean Change From Baseline in Individual Signs of TSS Oozing/crusting; EW;n=3,4,7,3,11,11	0.0 Scores on a scale Standard Deviation 0.00	0.0 Scores on a scale Standard Deviation 0.77	0.1 Scores on a scale Standard Deviation 0.70	-0.3 Scores on a scale Standard Deviation 0.58	0.8 Scores on a scale Standard Deviation 1.50	0.6 Scores on a scale Standard Deviation 1.40
Mean Change From Baseline in Individual Signs of TSS Scaling; Week 4;n=38,39,38,39,30,32	-0.8 Scores on a scale Standard Deviation 0.81	-0.7 Scores on a scale Standard Deviation 0.71	-0.6 Scores on a scale Standard Deviation 0.87	-0.8 Scores on a scale Standard Deviation 0.78	-0.7 Scores on a scale Standard Deviation 0.69	-0.8 Scores on a scale Standard Deviation 0.75
Mean Change From Baseline in Individual Signs of TSS Scaling; Week 8;n=36,37,34,38,29,27	-0.9 Scores on a scale Standard Deviation 0.71	-1.0 Scores on a scale Standard Deviation 0.76	-0.8 Scores on a scale Standard Deviation 0.88	-0.8 Scores on a scale Standard Deviation 0.79	-0.9 Scores on a scale Standard Deviation 0.66	-1.1 Scores on a scale Standard Deviation 0.71
Mean Change From Baseline in Individual Signs of TSS Scaling; Week 12;n=36,37,32,35,28,25	-1.0 Scores on a scale Standard Deviation 0.80	-1.0 Scores on a scale Standard Deviation 0.67	-0.9 Scores on a scale Standard Deviation 0.91	-1.1 Scores on a scale Standard Deviation 0.83	-0.9 Scores on a scale Standard Deviation 0.70	-1.2 Scores on a scale Standard Deviation 0.72
Mean Change From Baseline in Individual Signs of TSS Scaling; Week 14;n=34,35,31,33,27,25	-0.8 Scores on a scale Standard Deviation 0.87	-1.0 Scores on a scale Standard Deviation 0.81	-0.9 Scores on a scale Standard Deviation 0.88	-1.0 Scores on a scale Standard Deviation 0.85	-0.9 Scores on a scale Standard Deviation 0.73	-1.0 Scores on a scale Standard Deviation 0.80
Mean Change From Baseline in Individual Signs of TSS Scaling; Week 16;n=34,36,31,35,27,25	-0.9 Scores on a scale Standard Deviation 0.74	-1.1 Scores on a scale Standard Deviation 0.70	-0.8 Scores on a scale Standard Deviation 0.80	-1.0 Scores on a scale Standard Deviation 0.90	-0.8 Scores on a scale Standard Deviation 0.75	-1.0 Scores on a scale Standard Deviation 0.68
Mean Change From Baseline in Individual Signs of TSS Scaling; EW;n=3,4,7,3,11,11	-0.7 Scores on a scale Standard Deviation 0.58	-0.1 Scores on a scale Standard Deviation 1.04	0.0 Scores on a scale Standard Deviation 0.89	-0.3 Scores on a scale Standard Deviation 0.58	0.0 Scores on a scale Standard Deviation 1.41	0.0 Scores on a scale Standard Deviation 0.82

SECONDARY outcome

Timeframe: Week 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)

Population: ITT Population

The severity of the following signs: erythema, induration/papulation, lichenification, oozing/crusting, and scaling was assessed on a 4-point scale ranging from 0 (absent) to 3 (severe) and TSS (maximum score 15) was calculated based on these signs. Mean percent change from Baseline in individual signs of TSS was presented using mean and SD. Baseline value was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. NA indicates that data were not available. If the participant had more than 3 missing days during the week, then the weekly average was not calculated and treated as missing data and excluded from the analysis. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	GSK2894512 0.5% QD n=41 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=42 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=40 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	GSK2894512 1% BID n=40 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=41 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=43 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
Mean Percent Change From Baseline in Individual Signs of TSS Scaling; Week 2;n= 35,34,34,37,31,30	-44.1 Percentage Change Standard Deviation 51.10	-36.6 Percentage Change Standard Deviation 40.69	-12.8 Percentage Change Standard Deviation 43.04	-47.1 Percentage Change Standard Deviation 45.28	-64.7 Percentage Change Standard Deviation 45.28	-53.4 Percentage Change Standard Deviation 42.60
Mean Percent Change From Baseline in Individual Signs of TSS Scaling; Week 12;n=33,32,29,33,26,23	-71.2 Percentage Change Standard Deviation 48.46	-64.7 Percentage Change Standard Deviation 37.51	-54.3 Percentage Change Standard Deviation 52.03	-75.8 Percentage Change Standard Deviation 41.69	-84.4 Percentage Change Standard Deviation 32.22	-82.8 Percentage Change Standard Deviation 30.69
Mean Percent Change From Baseline in Individual Signs of TSS Scaling; Week 14;n=31,30,28,31,25,23	-60.2 Percentage Change Standard Deviation 63.78	-62.0 Percentage Change Standard Deviation 39.24	-52.2 Percentage Change Standard Deviation 43.90	-74.2 Percentage Change Standard Deviation 40.56	-73.3 Percentage Change Standard Deviation 48.66	-70.2 Percentage Change Standard Deviation 39.11
Mean Percent Change From Baseline in Individual Signs of TSS Scaling; Week 16;n=31,31,28,33,25,23	-65.7 Percentage Change Standard Deviation 44.08	-70.7 Percentage Change Standard Deviation 35.45	-51.4 Percentage Change Standard Deviation 51.23	-75.8 Percentage Change Standard Deviation 48.08	-66.1 Percentage Change Standard Deviation 50.64	-72.0 Percentage Change Standard Deviation 36.87
Mean Percent Change From Baseline in Individual Signs of TSS Scaling; EW;n=2,4,5,3,9,9	-50.0 Percentage Change Standard Deviation 50.00	-5.6 Percentage Change Standard Deviation 76.83	0.0 Percentage Change Standard Deviation 70.71	-50.0 Percentage Change Standard Deviation 70.71	0.0 Percentage Change Standard Deviation 141.42	-10.0 Percentage Change Standard Deviation 74.16
Mean Percent Change From Baseline in Individual Signs of TSS Erythema; Week 1; n= 38, 41, 39, 36, 38, 30	-19.9 Percentage Change Standard Deviation 27.26	-19.3 Percentage Change Standard Deviation 34.12	-8.9 Percentage Change Standard Deviation 37.07	-25.9 Percentage Change Standard Deviation 26.76	-35.4 Percentage Change Standard Deviation 37.86	-17.1 Percentage Change Standard Deviation 28.74
Mean Percent Change From Baseline in Individual Signs of TSS Erythema; Week 2; n= 39, 39, 39, 38, 33, 30	-36.0 Percentage Change Standard Deviation 36.46	-26.3 Percentage Change Standard Deviation 39.75	-12.8 Percentage Change Standard Deviation 56.34	-49.6 Percentage Change Standard Deviation 34.30	-49.1 Percentage Change Standard Deviation 35.86	-35.5 Percentage Change Standard Deviation 33.15
Mean Percent Change From Baseline in Individual Signs of TSS Erythema; Week 4; n= 38, 39, 38, 38, 30, 30	-45.6 Percentage Change Standard Deviation 38.10	-33.3 Percentage Change Standard Deviation 37.14	-30.6 Percentage Change Standard Deviation 42.23	-51.3 Percentage Change Standard Deviation 32.74	-59.0 Percentage Change Standard Deviation 32.86	-55.7 Percentage Change Standard Deviation 34.28
Mean Percent Change From Baseline in Individual Signs of TSS Erythema; Week 8; n= 36, 37, 34, 37, 29, 25	-58.6 Percentage Change Standard Deviation 35.05	-55.2 Percentage Change Standard Deviation 40.36	-44.0 Percentage Change Standard Deviation 48.80	-58.8 Percentage Change Standard Deviation 31.24	-69.8 Percentage Change Standard Deviation 33.06	-65.7 Percentage Change Standard Deviation 26.89
Mean Percent Change From Baseline in Individual Signs of TSS Erythema; Week 12; n= 36, 37, 32, 34, 28, 23	-66.7 Percentage Change Standard Deviation 34.33	-51.2 Percentage Change Standard Deviation 36.55	-52.2 Percentage Change Standard Deviation 38.70	-69.9 Percentage Change Standard Deviation 36.69	-69.4 Percentage Change Standard Deviation 37.37	-77.1 Percentage Change Standard Deviation 25.66
Mean Percent Change From Baseline in Individual Signs of TSS Erythema; Week 14; n= 34, 35, 31, 32, 27, 23	-49.5 Percentage Change Standard Deviation 34.26	-56.2 Percentage Change Standard Deviation 35.55	-48.6 Percentage Change Standard Deviation 34.05	-70.6 Percentage Change Standard Deviation 36.71	-66.2 Percentage Change Standard Deviation 37.37	-55.9 Percentage Change Standard Deviation 46.66
Mean Percent Change From Baseline in Individual Signs of TSS Erythema; Week 16; n= 34, 36 , 31, 34, 27, 23	-58.8 Percentage Change Standard Deviation 36.29	-50.6 Percentage Change Standard Deviation 40.95	-50.0 Percentage Change Standard Deviation 30.57	-67.2 Percentage Change Standard Deviation 36.58	-59.7 Percentage Change Standard Deviation 39.11	-60.2 Percentage Change Standard Deviation 44.03
Mean Percent Change From Baseline in Individual Signs of TSS Erythema; EW; n= 3, 4, 7, 3, 11, 11	-50.0 Percentage Change Standard Deviation 50.00	-10.6 Percentage Change Standard Deviation 42.99	18.2 Percentage Change Standard Deviation 87.39	-33.3 Percentage Change Standard Deviation 57.74	-8.3 Percentage Change Standard Deviation 44.10	-21.4 Percentage Change Standard Deviation 48.80
Mean Percent Change From Baseline in Individual Signs of TSS Induration/Papulation;Week 1; n=38,40,37,37,38,32	-18.0 Percentage Change Standard Deviation 25.27	-12.7 Percentage Change Standard Deviation 41.27	-3.1 Percentage Change Standard Deviation 35.78	-18.0 Percentage Change Standard Deviation 26.67	-28.3 Percentage Change Standard Deviation 33.16	-21.6 Percentage Change Standard Deviation 26.02
Mean Percent Change From Baseline in Individual Signs of TSS Induration/Papulation;Week 2;n= 39,38,37,39,33,32	-40.6 Percentage Change Standard Deviation 43.05	-22.7 Percentage Change Standard Deviation 47.47	-14.6 Percentage Change Standard Deviation 55.48	-43.2 Percentage Change Standard Deviation 40.05	-46.9 Percentage Change Standard Deviation 38.91	-41.0 Percentage Change Standard Deviation 40.37
Mean Percent Change From Baseline in Individual Signs of TSS Induration/Papulation;Week 4;n= 38,38,36,39,30,32	-43.6 Percentage Change Standard Deviation 51.24	-31.1 Percentage Change Standard Deviation 32.38	-31.8 Percentage Change Standard Deviation 43.04	-49.1 Percentage Change Standard Deviation 45.84	-61.0 Percentage Change Standard Deviation 38.22	-56.5 Percentage Change Standard Deviation 32.68
Mean Percent Change From Baseline in Individual Signs of TSS Induration/Papulation;Week 8;n= 36,36,33,38,29,27	-65.8 Percentage Change Standard Deviation 36.55	-54.0 Percentage Change Standard Deviation 46.64	-44.4 Percentage Change Standard Deviation 43.85	-57.9 Percentage Change Standard Deviation 35.07	-58.8 Percentage Change Standard Deviation 43.37	-70.7 Percentage Change Standard Deviation 27.96
Mean Percent Change From Baseline in Individual Signs of TSS Induration/Papulation;Week 12;n=36,36,31,35,28,25	-65.2 Percentage Change Standard Deviation 34.39	-41.7 Percentage Change Standard Deviation 47.90	-54.7 Percentage Change Standard Deviation 40.69	-72.2 Percentage Change Standard Deviation 46.97	-68.5 Percentage Change Standard Deviation 43.60	-79.6 Percentage Change Standard Deviation 26.77
Mean Percent Change From Baseline in Individual Signs of TSS Induration/Papulation;Week 14;n=34,34,30,33,27,25	-46.5 Percentage Change Standard Deviation 39.69	-50.0 Percentage Change Standard Deviation 48.48	-56.0 Percentage Change Standard Deviation 39.35	-65.7 Percentage Change Standard Deviation 44.18	-73.5 Percentage Change Standard Deviation 31.55	-63.9 Percentage Change Standard Deviation 32.48
Mean Percent Change From Baseline in Individual Signs of TSS Induration/Papulation;Week 16;n=34,35,30,35,27,25	-61.0 Percentage Change Standard Deviation 38.97	-51.2 Percentage Change Standard Deviation 43.10	-52.0 Percentage Change Standard Deviation 49.14	-65.7 Percentage Change Standard Deviation 42.43	-62.4 Percentage Change Standard Deviation 38.84	-67.8 Percentage Change Standard Deviation 35.81
Mean Percent Change From Baseline in Individual Signs of TSS Induration/Papulation; EW; n= 3,4,6,3,11,11	0.0 Percentage Change Standard Deviation 100.00	-4.5 Percentage Change Standard Deviation 56.81	27.3 Percentage Change Standard Deviation 103.35	0.0 Percentage Change Standard Deviation 100.00	-12.5 Percentage Change Standard Deviation 62.92	-16.7 Percentage Change Standard Deviation 68.31
Mean Percent Change From Baseline in Individual Signs of TSS Lichenification; Week 1;n=34,37,38,37,37,32	-16.7 Percentage Change Standard Deviation 33.10	-19.8 Percentage Change Standard Deviation 29.88	-13.5 Percentage Change Standard Deviation 28.54	-22.1 Percentage Change Standard Deviation 39.51	-30.6 Percentage Change Standard Deviation 40.73	-24.6 Percentage Change Standard Deviation 39.85
Mean Percent Change From Baseline in Individual Signs of TSS Lichenification; Week 2;n=35,36,38,39,32,32	-38.5 Percentage Change Standard Deviation 41.56	-39.1 Percentage Change Standard Deviation 39.85	-19.3 Percentage Change Standard Deviation 46.97	-38.1 Percentage Change Standard Deviation 45.83	-46.3 Percentage Change Standard Deviation 42.56	-36.8 Percentage Change Standard Deviation 37.60
Mean Percent Change From Baseline in Individual Signs of TSS Lichenification; Week 4;n=34,36,37,39,29,32	-45.3 Percentage Change Standard Deviation 40.64	-32.2 Percentage Change Standard Deviation 46.91	-23.4 Percentage Change Standard Deviation 48.61	-47.1 Percentage Change Standard Deviation 48.80	-51.9 Percentage Change Standard Deviation 36.47	-56.3 Percentage Change Standard Deviation 37.34
Mean Percent Change From Baseline in Individual Signs of TSS Lichenification; Week 8;n=33,35,33,38,28,27	-60.1 Percentage Change Standard Deviation 39.24	-53.0 Percentage Change Standard Deviation 36.59	-49.4 Percentage Change Standard Deviation 37.12	-53.5 Percentage Change Standard Deviation 47.10	-62.9 Percentage Change Standard Deviation 38.58	-62.1 Percentage Change Standard Deviation 32.62
Mean Percent Change From Baseline in Individual Signs of TSS Lichenification; Week 12;n=33,35,31,35,27,25	-64.8 Percentage Change Standard Deviation 37.44	-57.4 Percentage Change Standard Deviation 36.50	-67.3 Percentage Change Standard Deviation 35.84	-71.7 Percentage Change Standard Deviation 41.56	-69.0 Percentage Change Standard Deviation 36.86	-78.5 Percentage Change Standard Deviation 23.25
Mean Percent Change From Baseline in Individual Signs of TSS Lichenification; Week 14;n=31,33,30,33,26,25	-56.6 Percentage Change Standard Deviation 36.07	-54.5 Percentage Change Standard Deviation 40.15	-60.7 Percentage Change Standard Deviation 36.92	-73.7 Percentage Change Standard Deviation 38.19	-62.6 Percentage Change Standard Deviation 43.71	-59.4 Percentage Change Standard Deviation 43.92
Mean Percent Change From Baseline in Individual Signs of TSS Lichenification; Week 16;n=31,34,30,35,26,25	-60.0 Percentage Change Standard Deviation 37.31	-57.7 Percentage Change Standard Deviation 39.79	-68.7 Percentage Change Standard Deviation 33.44	-65.6 Percentage Change Standard Deviation 45.12	-60.3 Percentage Change Standard Deviation 43.81	-66.1 Percentage Change Standard Deviation 34.04
Mean Percent Change From Baseline in Individual Signs of TSS Lichenification; EW;n= 2,2,7,3,11,11	-50.0 Percentage Change Standard Deviation 50.00	-16.7 Percentage Change Standard Deviation 39.44	-9.1 Percentage Change Standard Deviation 62.52	-50.0 Percentage Change Standard Deviation 70.71	-25.0 Percentage Change Standard Deviation 106.07	-21.4 Percentage Change Standard Deviation 69.86
Mean Percent Change From Baseline in Individual Signs of TSS Oozing/crusting; Week 1;n=24,21,26,27,27,22	-40.7 Percentage Change Standard Deviation 48.11	-44.4 Percentage Change Standard Deviation 65.54	-20.5 Percentage Change Standard Deviation 50.38	-29.2 Percentage Change Standard Deviation 52.99	-61.9 Percentage Change Standard Deviation 47.18	-40.4 Percentage Change Standard Deviation 46.95
Mean Percent Change From Baseline in Individual Signs of TSS Oozing/crusting; Week 2;n=24,21,27,28,22,23	-51.8 Percentage Change Standard Deviation 48.08	-62.9 Percentage Change Standard Deviation 44.52	-37.0 Percentage Change Standard Deviation 43.22	-64.6 Percentage Change Standard Deviation 47.73	-64.3 Percentage Change Standard Deviation 42.26	-75.9 Percentage Change Standard Deviation 37.65
Mean Percent Change From Baseline in Individual Signs of TSS Oozing/crusting; Week 4;n= 24,21,27,28,21,24	-76.8 Percentage Change Standard Deviation 41.90	-68.3 Percentage Change Standard Deviation 43.75	-45.8 Percentage Change Standard Deviation 55.00	-75.0 Percentage Change Standard Deviation 44.23	-69.0 Percentage Change Standard Deviation 43.23	-79.0 Percentage Change Standard Deviation 44.96
Mean Percent Change From Baseline in Individual Signs of TSS Oozing/crusting; Week 8;n=23,20,25,27,21,21	-85.2 Percentage Change Standard Deviation 36.20	-65.9 Percentage Change Standard Deviation 43.29	-59.5 Percentage Change Standard Deviation 56.17	-82.6 Percentage Change Standard Deviation 38.76	-97.5 Percentage Change Standard Deviation 11.18	-84.7 Percentage Change Standard Deviation 33.99
Mean Percent Change From Baseline in Individual Signs of TSS Oozing/crusting; Week 12;n=23,20,23,25,21,19	-86.0 Percentage Change Standard Deviation 33.91	-74.6 Percentage Change Standard Deviation 40.35	-73.7 Percentage Change Standard Deviation 71.43	-84.8 Percentage Change Standard Deviation 35.15	-87.5 Percentage Change Standard Deviation 31.93	-97.8 Percentage Change Standard Deviation 10.43
Mean Percent Change From Baseline in Individual Signs of TSS Oozing/crusting; Week 14;n=22,19,23,23,21,19	-80.4 Percentage Change Standard Deviation 39.14	-84.9 Percentage Change Standard Deviation 33.29	-76.3 Percentage Change Standard Deviation 42.06	-86.4 Percentage Change Standard Deviation 35.13	-73.7 Percentage Change Standard Deviation 56.20	-84.8 Percentage Change Standard Deviation 32.14
Mean Percent Change From Baseline in Individual Signs of TSS Oozing/crusting; Week 16;n=22,20,23,25,21,19	-84.0 Percentage Change Standard Deviation 34.52	-75.4 Percentage Change Standard Deviation 41.37	-71.1 Percentage Change Standard Deviation 56.06	-79.5 Percentage Change Standard Deviation 39.82	-80.0 Percentage Change Standard Deviation 41.04	-84.8 Percentage Change Standard Deviation 35.15
Mean Percent Change From Baseline in Individual Signs of TSS Oozing/crusting; EW;n=1,1,4,2,5,5	0.0 Percentage Change Standard Deviation 0.00	-20.0 Percentage Change Standard Deviation 44.72	-20.0 Percentage Change Standard Deviation 44.72	-100.0 Percentage Change Standard Deviation NA NA indicates that data is not available	0.0 Percentage Change Standard Deviation NA NA indicates that data is not available	-12.5 Percentage Change Standard Deviation 103.08
Mean Percent Change From Baseline in Individual Signs of TSS Scaling; Week 1;n=34,36,34,35,36,29	-19.5 Percentage Change Standard Deviation 58.23	-24.1 Percentage Change Standard Deviation 41.87	-8.6 Percentage Change Standard Deviation 42.40	-28.4 Percentage Change Standard Deviation 52.79	-36.1 Percentage Change Standard Deviation 47.22	-32.8 Percentage Change Standard Deviation 47.76
Mean Percent Change From Baseline in Individual Signs of TSS Scaling; Week 4;n=35,34,34,37,28,30	-51.8 Percentage Change Standard Deviation 52.08	-38.1 Percentage Change Standard Deviation 36.81	-33.3 Percentage Change Standard Deviation 53.07	-57.1 Percentage Change Standard Deviation 45.61	-69.1 Percentage Change Standard Deviation 40.85	-68.1 Percentage Change Standard Deviation 47.38
Mean Percent Change From Baseline in Individual Signs of TSS Scaling; Week 8;n=33,32,30,36,27,25	-67.1 Percentage Change Standard Deviation 43.00	-59.3 Percentage Change Standard Deviation 38.49	-50.0 Percentage Change Standard Deviation 52.04	-57.6 Percentage Change Standard Deviation 50.19	-81.3 Percentage Change Standard Deviation 35.36	-81.7 Percentage Change Standard Deviation 30.75

SECONDARY outcome

Timeframe: Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)

Population: ITT Population

The extent of BSA affected by AD is a general indicator of disease severity and the assessment of BSA with AD was performed separately for four body surface regions: the head (h), the upper extremities (u), the trunk (t) and the lower extremities (l), corresponding to 10, 20, 30, and 40 percent of the total body area, respectively. Mean change from Baseline in percent BSA was presented using mean and SD at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW visit. Baseline was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	GSK2894512 0.5% QD n=41 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=42 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=40 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	GSK2894512 1% BID n=40 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=41 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=43 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
Mean Change From Baseline in Body Surface Area (Percent BSA) Week 1; n= 38, 41, 39, 37, 38, 32	-1.52 Percentage of surface area Standard Deviation 6.078	-0.33 Percentage of surface area Standard Deviation 6.591	-0.25 Percentage of surface area Standard Deviation 4.411	-2.37 Percentage of surface area Standard Deviation 4.774	-3.57 Percentage of surface area Standard Deviation 5.498	-2.44 Percentage of surface area Standard Deviation 4.313
Mean Change From Baseline in Body Surface Area (Percent BSA) Week 2; n= 39, 39, 39, 39, 33, 32	-3.78 Percentage of surface area Standard Deviation 5.897	-2.01 Percentage of surface area Standard Deviation 6.484	-0.04 Percentage of surface area Standard Deviation 4.698	-4.99 Percentage of surface area Standard Deviation 7.330	-7.07 Percentage of surface area Standard Deviation 6.639	-4.88 Percentage of surface area Standard Deviation 5.243
Mean Change From Baseline in Body Surface Area (Percent BSA) Week 4; n= 38, 39, 38, 39, 30, 32	-7.07 Percentage of surface area Standard Deviation 6.382	-2.93 Percentage of surface area Standard Deviation 7.772	-2.05 Percentage of surface area Standard Deviation 6.517	-7.37 Percentage of surface area Standard Deviation 6.276	-9.76 Percentage of surface area Standard Deviation 8.581	-7.47 Percentage of surface area Standard Deviation 7.567
Mean Change From Baseline in Body Surface Area (Percent BSA) Week 8; n= 36, 37, 34, 38, 29, 27	-8.56 Percentage of surface area Standard Deviation 6.217	-5.41 Percentage of surface area Standard Deviation 7.961	-3.33 Percentage of surface area Standard Deviation 7.264	-9.23 Percentage of surface area Standard Deviation 8.425	-11.70 Percentage of surface area Standard Deviation 9.208	-10.89 Percentage of surface area Standard Deviation 9.692
Mean Change From Baseline in Body Surface Area (Percent BSA) Week 12; n= 36, 37, 32, 35, 28, 25	-9.81 Percentage of surface area Standard Deviation 7.717	-6.00 Percentage of surface area Standard Deviation 8.424	-5.44 Percentage of surface area Standard Deviation 8.079	-11.19 Percentage of surface area Standard Deviation 8.643	-11.55 Percentage of surface area Standard Deviation 9.690	-12.18 Percentage of surface area Standard Deviation 9.581
Mean Change From Baseline in Body Surface Area (Percent BSA) Week 14; n= 34, 35, 31, 33, 27, 25	-9.26 Percentage of surface area Standard Deviation 7.529	-5.60 Percentage of surface area Standard Deviation 7.575	-5.80 Percentage of surface area Standard Deviation 6.987	-9.25 Percentage of surface area Standard Deviation 7.121	-9.85 Percentage of surface area Standard Deviation 9.446	-11.26 Percentage of surface area Standard Deviation 10.262
Mean Change From Baseline in Body Surface Area (Percent BSA) Week 16; n= 34, 36, 31, 35, 27, 25	-9.25 Percentage of surface area Standard Deviation 8.399	-5.66 Percentage of surface area Standard Deviation 7.695	-5.53 Percentage of surface area Standard Deviation 7.227	-8.19 Percentage of surface area Standard Deviation 7.826	-9.93 Percentage of surface area Standard Deviation 8.820	-10.92 Percentage of surface area Standard Deviation 9.903
Mean Change From Baseline in Body Surface Area (Percent BSA) EW; n= 3, 4, 7, 3, 11, 11	3.20 Percentage of surface area Standard Deviation 14.468	3.36 Percentage of surface area Standard Deviation 9.492	7.50 Percentage of surface area Standard Deviation 18.476	-2.60 Percentage of surface area Standard Deviation 4.613	4.63 Percentage of surface area Standard Deviation 9.586	5.36 Percentage of surface area Standard Deviation 21.468

SECONDARY outcome

Timeframe: Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)

Population: ITT Population

The IGA is a clinical tool for assessing the current state/severity of a participant's AD. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines. IGA is made without reference to previous scores. Score ranges from 0 (clear) to 4 (severe). Higher values represent a severe disease. Mean change from Baseline in IGA score was presented using mean and SD at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW visit. Baseline was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	GSK2894512 0.5% QD n=41 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=42 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=40 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	GSK2894512 1% BID n=40 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=41 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=43 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
Mean Change From Baseline in IGA Score Week 1; n= 38, 41, 39, 37, 38, 32	-0.4 Scores on a scale Standard Deviation 0.55	-0.3 Scores on a scale Standard Deviation 0.58	-0.4 Scores on a scale Standard Deviation 0.62	-0.5 Scores on a scale Standard Deviation 0.60	-0.6 Scores on a scale Standard Deviation 0.67	-0.3 Scores on a scale Standard Deviation 0.48
Mean Change From Baseline in IGA Score Week 2; n= 39, 39, 39, 39, 33, 32	-0.7 Scores on a scale Standard Deviation 0.79	-0.7 Scores on a scale Standard Deviation 0.72	-0.5 Scores on a scale Standard Deviation 0.72	-1.0 Scores on a scale Standard Deviation 0.69	-0.9 Scores on a scale Standard Deviation 0.70	-0.6 Scores on a scale Standard Deviation 0.67
Mean Change From Baseline in IGA Score Week 4; n= 38, 39, 38, 39, 30, 32	-1.0 Scores on a scale Standard Deviation 0.81	-1.0 Scores on a scale Standard Deviation 0.72	-0.7 Scores on a scale Standard Deviation 0.82	-1.3 Scores on a scale Standard Deviation 0.86	-1.4 Scores on a scale Standard Deviation 0.81	-1.1 Scores on a scale Standard Deviation 0.77
Mean Change From Baseline in IGA Score Week 8; n= 36, 37, 34, 38, 29, 27	-1.4 Scores on a scale Standard Deviation 0.85	-1.2 Scores on a scale Standard Deviation 0.60	-1.0 Scores on a scale Standard Deviation 0.88	-1.4 Scores on a scale Standard Deviation 0.83	-1.6 Scores on a scale Standard Deviation 0.82	-1.3 Scores on a scale Standard Deviation 0.84
Mean Change From Baseline in IGA Score Week 12; n= 36, 37, 32, 35, 28, 25	-1.5 Scores on a scale Standard Deviation 0.95	-1.3 Scores on a scale Standard Deviation 0.72	-1.2 Scores on a scale Standard Deviation 0.78	-1.7 Scores on a scale Standard Deviation 0.96	-1.6 Scores on a scale Standard Deviation 0.83	-1.6 Scores on a scale Standard Deviation 0.76
Mean Change From Baseline in IGA Score Week 14; n= 34, 35, 31, 33, 27, 25	-1.3 Scores on a scale Standard Deviation 0.92	-1.2 Scores on a scale Standard Deviation 0.85	-1.2 Scores on a scale Standard Deviation 0.75	-1.5 Scores on a scale Standard Deviation 1.08	-1.4 Scores on a scale Standard Deviation 0.77	-1.5 Scores on a scale Standard Deviation 0.99
Mean Change From Baseline in IGA Score Week 16; n= 34, 36, 31, 35, 27, 25	-1.3 Scores on a scale Standard Deviation 0.94	-1.3 Scores on a scale Standard Deviation 0.90	-1.1 Scores on a scale Standard Deviation 0.73	-1.2 Scores on a scale Standard Deviation 1.07	-1.2 Scores on a scale Standard Deviation 0.74	-1.4 Scores on a scale Standard Deviation 0.91
Mean Change From Baseline in IGA Score EW; n= 3, 4, 7, 3, 11, 11	-1.0 Scores on a scale Standard Deviation 1.00	0.1 Scores on a scale Standard Deviation 0.30	0.0 Scores on a scale Standard Deviation 0.89	-1.3 Scores on a scale Standard Deviation 1.53	0.3 Scores on a scale Standard Deviation 0.50	-0.6 Scores on a scale Standard Deviation 0.98

SECONDARY outcome

Timeframe: Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to week 16)

Population: ITT Population

The IGA is a clinical tool for assessing the current state/severity of a participant's AD. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines. IGA is made without reference to previous scores. The percentage of participants who have an IGA score of clear or almost clear and a minimum 2 grade improvement from Baseline to each study visit in IGA score was presented. The statistical analysis was performed using a repeated measures factorial logistic regression model with covariates for dose, frequency of administration, and study day as well as a dose by frequency interaction term. The analysis was performed on ITT Population which comprised of all randomized participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category title).

Outcome measures

Outcome measures
Measure	GSK2894512 0.5% QD n=41 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=42 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=40 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	GSK2894512 1% BID n=40 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=41 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=43 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit Week 1; n= 38,41,39,37,38,32	3 Percentage of participants	3 Percentage of participants	3 Percentage of participants	5 Percentage of participants	5 Percentage of participants	0 Percentage of participants
Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit Week 2; n= 39,39,39,39,33,32	13 Percentage of participants	15 Percentage of participants	9 Percentage of participants	18 Percentage of participants	18 Percentage of participants	10 Percentage of participants
Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit Week 14; n= 34,35,31,33,27,25	36 Percentage of participants	26 Percentage of participants	36 Percentage of participants	44 Percentage of participants	43 Percentage of participants	52 Percentage of participants
Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit Week 16; n= 34,36,31,35,27,25	40 Percentage of participants	30 Percentage of participants	28 Percentage of participants	35 Percentage of participants	36 Percentage of participants	39 Percentage of participants
Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit EW; n= 3,4,7,3,11,11	33 Percentage of participants	0 Percentage of participants	9 Percentage of participants	33 Percentage of participants	0 Percentage of participants	14 Percentage of participants
Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit Week 4; n= 38,39,38,39,30,32	23 Percentage of participants	20 Percentage of participants	9 Percentage of participants	32 Percentage of participants	38 Percentage of participants	26 Percentage of participants
Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit Week 8; n= 36,37,34,38,29,27	42 Percentage of participants	28 Percentage of participants	19 Percentage of participants	42 Percentage of participants	54 Percentage of participants	38 Percentage of participants
Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit Week 12; n= 36,37,32,35,28,25	40 Percentage of participants	36 Percentage of participants	44 Percentage of participants	58 Percentage of participants	51 Percentage of participants	50 Percentage of participants

SECONDARY outcome

Timeframe: Weeks 1, 2, 4, 8, 12, 14, EW (up to week 14)

Population: Safety Population

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth effect, other situations and is associated with liver injury or impaired liver function. Treatment emergent AEs (TEAE) is defined as AE occurred on or after study treatment start date and on or before last visit. Number of participants with AEs and serious TEAEs were presented. The analysis was performed on Safety population which comprised of all participants who receive at least one dose of study treatment.

Outcome measures

Outcome measures
Measure	GSK2894512 0.5% QD n=41 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=42 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=40 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	GSK2894512 1% BID n=40 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=41 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=43 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs TEAEs	23 Participants	19 Participants	15 Participants	28 Participants	22 Participants	20 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs Serious TEAEs	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 1, 2, 4, 8, 12, 14, EW (up to Week 14)

Population: Safety Population

Participants were asked to use a 5-point tolerability scale from 0 (none) to 4 (severe) to assess the presence and degree of burning/stinging and itching at the application sites that has generally been experienced following application of the study treatment. The score represented an 'average' across all application sites. A score of 3 or 4 was reported as an AE. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	GSK2894512 0.5% QD n=41 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=42 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=40 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	GSK2894512 1% BID n=40 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=41 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=43 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
Number of Participants With Reported Tolerability Score of 0 to 4 Over Time Week 1; slight; n= 38,40,39,37,38,33	6 Participants	9 Participants	5 Participants	6 Participants	10 Participants	5 Participants
Number of Participants With Reported Tolerability Score of 0 to 4 Over Time EW; mild; n= 3,4,7,3,11,11	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Reported Tolerability Score of 0 to 4 Over Time Week 1; none; n= 38,40,39,37,38,33	21 Participants	15 Participants	22 Participants	19 Participants	25 Participants	25 Participants
Number of Participants With Reported Tolerability Score of 0 to 4 Over Time Week 1; mild; n= 38,40,39,37,38,33	8 Participants	6 Participants	3 Participants	9 Participants	3 Participants	2 Participants
Number of Participants With Reported Tolerability Score of 0 to 4 Over Time Week 1; Moderate; n= 38,40,39,37,38,33	2 Participants	7 Participants	2 Participants	2 Participants	2 Participants	6 Participants
Number of Participants With Reported Tolerability Score of 0 to 4 Over Time Week 1; severe; n= 38,40,39,37,38,33	0 Participants	1 Participants	1 Participants	2 Participants	0 Participants	1 Participants
Number of Participants With Reported Tolerability Score of 0 to 4 Over Time Week 2; none; n= 39,37,39,39,33,32	20 Participants	16 Participants	18 Participants	26 Participants	27 Participants	33 Participants
Number of Participants With Reported Tolerability Score of 0 to 4 Over Time Week 2; slight;n= 39,37,39,39,33,32	11 Participants	6 Participants	5 Participants	5 Participants	5 Participants	1 Participants
Number of Participants With Reported Tolerability Score of 0 to 4 Over Time Week 2; mild; n= 39,37,39,39,33,32	4 Participants	8 Participants	5 Participants	3 Participants	4 Participants	4 Participants
Number of Participants With Reported Tolerability Score of 0 to 4 Over Time Week 2; moderate; n= 39,37,39,39,33,32	3 Participants	2 Participants	2 Participants	4 Participants	0 Participants	1 Participants
Number of Participants With Reported Tolerability Score of 0 to 4 Over Time Week 2; severe; n= 39,37,39,39,33,32	1 Participants	1 Participants	2 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Reported Tolerability Score of 0 to 4 Over Time Week 4; none; n= 38, 39, 38,39,29,32	27 Participants	15 Participants	21 Participants	26 Participants	26 Participants	27 Participants
Number of Participants With Reported Tolerability Score of 0 to 4 Over Time Week 4; slight; n= 38, 39, 38,39,29,32	9 Participants	8 Participants	2 Participants	7 Participants	8 Participants	5 Participants
Number of Participants With Reported Tolerability Score of 0 to 4 Over Time Week 4; mild; n= 38, 39, 38,39,29,32	2 Participants	4 Participants	5 Participants	3 Participants	4 Participants	6 Participants
Number of Participants With Reported Tolerability Score of 0 to 4 Over Time Week 4; moderate; n= 38, 39, 38,39,29,32	1 Participants	2 Participants	3 Participants	2 Participants	1 Participants	0 Participants
Number of Participants With Reported Tolerability Score of 0 to 4 Over Time Week 4; severe; n= 38, 39, 38,39,29,32	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Reported Tolerability Score of 0 to 4 Over Time Week 8; none; n= 36, 37, 34, 38, 29, 28	29 Participants	19 Participants	17 Participants	25 Participants	28 Participants	23 Participants
Number of Participants With Reported Tolerability Score of 0 to 4 Over Time Week 8; slight; n= 36, 37, 34, 38, 29, 28	7 Participants	5 Participants	5 Participants	6 Participants	6 Participants	8 Participants
Number of Participants With Reported Tolerability Score of 0 to 4 Over Time Week 8; mild; n= 36, 37, 34, 38, 29, 28	2 Participants	3 Participants	3 Participants	3 Participants	2 Participants	2 Participants
Number of Participants With Reported Tolerability Score of 0 to 4 Over Time Week 8; moderate; n= 36, 37, 34, 38, 29, 28	0 Participants	1 Participants	3 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Reported Tolerability Score of 0 to 4 Over Time Week 8; severe; n= 36, 37, 34, 38, 29, 28	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Reported Tolerability Score of 0 to 4 Over Time Week 12; none; n= 36, 37, 32, 35, 28, 28	27 Participants	16 Participants	23 Participants	24 Participants	27 Participants	26 Participants
Number of Participants With Reported Tolerability Score of 0 to 4 Over Time Week 12; slight; n= 36, 37, 32, 35, 28, 28	6 Participants	8 Participants	3 Participants	6 Participants	8 Participants	3 Participants
Number of Participants With Reported Tolerability Score of 0 to 4 Over Time Week 12; mild; n= 36, 37, 32, 35, 28, 28	2 Participants	3 Participants	0 Participants	5 Participants	1 Participants	3 Participants
Number of Participants With Reported Tolerability Score of 0 to 4 Over Time Week 12; moderate; n= 36, 37, 32, 35, 28, 28	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Reported Tolerability Score of 0 to 4 Over Time Week 12; severe; n= 36, 37, 32, 35, 28, 28	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Reported Tolerability Score of 0 to 4 Over Time Week 14; none; n= 34,35,32,33,31,29	26 Participants	22 Participants	22 Participants	26 Participants	29 Participants	27 Participants
Number of Participants With Reported Tolerability Score of 0 to 4 Over Time Week 14; slight; n= 34,35,32,33,31,29	5 Participants	4 Participants	4 Participants	4 Participants	5 Participants	4 Participants
Number of Participants With Reported Tolerability Score of 0 to 4 Over Time Week 14; mild; n= 34,35,32,33,31,29	2 Participants	2 Participants	2 Participants	3 Participants	0 Participants	0 Participants
Number of Participants With Reported Tolerability Score of 0 to 4 Over Time Week 14; moderate; n= 34,35,32,33,31,29	0 Participants	2 Participants	1 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Reported Tolerability Score of 0 to 4 Over Time Week 14; severe; n= 34,35,32,33,31,29	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Reported Tolerability Score of 0 to 4 Over Time EW; none; n= 3,4,7,3,11,11	2 Participants	3 Participants	7 Participants	2 Participants	1 Participants	4 Participants
Number of Participants With Reported Tolerability Score of 0 to 4 Over Time EW; slight; n= 3,4,7,3,11,11	0 Participants	4 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Reported Tolerability Score of 0 to 4 Over Time EW; moderate; n= 3,4,7,3,11,11	1 Participants	1 Participants	2 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With Reported Tolerability Score of 0 to 4 Over Time EW; severe; n= 3,4,7,3,11,11	0 Participants	3 Participants	1 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Week 1, 2, 4, 8, 12, 14, EW (up to week 14)

Population: Safety Population

Blood samples were collected to evaluate change from Baseline in albumin and total protein values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.

Outcome measures

Outcome measures
Measure	GSK2894512 0.5% QD n=41 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=42 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=40 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	GSK2894512 1% BID n=40 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=41 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=43 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
Change From Baseline in Albumin and Total Protein Albumin; Week 2; n=38,39,38,39,33,32	-1.4 Gram per Liter (G/L) Standard Deviation 2.02	-1.2 Gram per Liter (G/L) Standard Deviation 3.91	-1.2 Gram per Liter (G/L) Standard Deviation 2.17	-1.2 Gram per Liter (G/L) Standard Deviation 2.96	-1.3 Gram per Liter (G/L) Standard Deviation 1.89	-2.2 Gram per Liter (G/L) Standard Deviation 2.96
Change From Baseline in Albumin and Total Protein Albumin; Week 4; n=38,39,38,38,30,32	-1.3 Gram per Liter (G/L) Standard Deviation 2.74	-1.2 Gram per Liter (G/L) Standard Deviation 2.46	-0.7 Gram per Liter (G/L) Standard Deviation 2.74	-1.1 Gram per Liter (G/L) Standard Deviation 2.87	-0.6 Gram per Liter (G/L) Standard Deviation 2.17	-1.9 Gram per Liter (G/L) Standard Deviation 2.49
Change From Baseline in Albumin and Total Protein Albumin; Week 8; n= 35,37,34,38,29,28	-1.1 Gram per Liter (G/L) Standard Deviation 2.29	-1.4 Gram per Liter (G/L) Standard Deviation 2.54	-1.4 Gram per Liter (G/L) Standard Deviation 3.14	-1.7 Gram per Liter (G/L) Standard Deviation 2.47	-1.0 Gram per Liter (G/L) Standard Deviation 1.86	-1.9 Gram per Liter (G/L) Standard Deviation 2.38
Change From Baseline in Albumin and Total Protein Albumin; Week 12; n= 36,37,32,35,28,28	-1.7 Gram per Liter (G/L) Standard Deviation 2.47	-1.6 Gram per Liter (G/L) Standard Deviation 2.79	-0.9 Gram per Liter (G/L) Standard Deviation 2.09	-1.1 Gram per Liter (G/L) Standard Deviation 2.48	-1.2 Gram per Liter (G/L) Standard Deviation 2.65	-2.2 Gram per Liter (G/L) Standard Deviation 2.35
Change From Baseline in Albumin and Total Protein Albumin; Week 14; n= 33,35,32,34,31,29	-1.6 Gram per Liter (G/L) Standard Deviation 3.04	-2.0 Gram per Liter (G/L) Standard Deviation 2.70	-0.9 Gram per Liter (G/L) Standard Deviation 2.21	-1.6 Gram per Liter (G/L) Standard Deviation 2.36	-1.5 Gram per Liter (G/L) Standard Deviation 2.41	-2.0 Gram per Liter (G/L) Standard Deviation 2.48
Change From Baseline in Albumin and Total Protein Albumin; EW;n = 3,3,7,3,11,11	-0.7 Gram per Liter (G/L) Standard Deviation 0.58	-0.7 Gram per Liter (G/L) Standard Deviation 2.87	-2.5 Gram per Liter (G/L) Standard Deviation 2.84	-1.3 Gram per Liter (G/L) Standard Deviation 4.04	-3.3 Gram per Liter (G/L) Standard Deviation 2.52	-3.0 Gram per Liter (G/L) Standard Deviation 1.29
Change From Baseline in Albumin and Total Protein Total protein; Week 2; n= 38,39,38,39,33,32	-2.0 Gram per Liter (G/L) Standard Deviation 3.34	-1.9 Gram per Liter (G/L) Standard Deviation 6.66	-1.6 Gram per Liter (G/L) Standard Deviation 3.31	-1.5 Gram per Liter (G/L) Standard Deviation 4.49	-2.2 Gram per Liter (G/L) Standard Deviation 2.84	-2.3 Gram per Liter (G/L) Standard Deviation 4.48
Change From Baseline in Albumin and Total Protein Total protein; Week 4; n= 38,39,38,38,30,32	-1.7 Gram per Liter (G/L) Standard Deviation 5.12	-2.3 Gram per Liter (G/L) Standard Deviation 3.86	-1.1 Gram per Liter (G/L) Standard Deviation 4.62	-1.9 Gram per Liter (G/L) Standard Deviation 4.32	-1.1 Gram per Liter (G/L) Standard Deviation 3.49	-2.4 Gram per Liter (G/L) Standard Deviation 4.43
Change From Baseline in Albumin and Total Protein Total protein; Week 8; n= 35,37,34,38,29,28	-1.7 Gram per Liter (G/L) Standard Deviation 3.89	-1.7 Gram per Liter (G/L) Standard Deviation 4.09	-1.8 Gram per Liter (G/L) Standard Deviation 4.82	-2.8 Gram per Liter (G/L) Standard Deviation 3.91	-2.1 Gram per Liter (G/L) Standard Deviation 3.02	-2.8 Gram per Liter (G/L) Standard Deviation 4.46
Change From Baseline in Albumin and Total Protein Total protein; Week 12; n= 36,37,32,35,28,28	-2.4 Gram per Liter (G/L) Standard Deviation 4.07	-2.2 Gram per Liter (G/L) Standard Deviation 5.38	-1.0 Gram per Liter (G/L) Standard Deviation 3.18	-2.0 Gram per Liter (G/L) Standard Deviation 4.16	-2.5 Gram per Liter (G/L) Standard Deviation 4.43	-3.8 Gram per Liter (G/L) Standard Deviation 4.40
Change From Baseline in Albumin and Total Protein Total protein; Week 14; n= 33,35,32,34,31,29	-2.0 Gram per Liter (G/L) Standard Deviation 4.75	-2.3 Gram per Liter (G/L) Standard Deviation 4.26	-1.3 Gram per Liter (G/L) Standard Deviation 3.84	-3.0 Gram per Liter (G/L) Standard Deviation 3.80	-2.4 Gram per Liter (G/L) Standard Deviation 3.23	-3.3 Gram per Liter (G/L) Standard Deviation 4.07
Change From Baseline in Albumin and Total Protein Total protein; EW; n= 3,3,7,3,11,11	-1.0 Gram per Liter (G/L) Standard Deviation 2.00	-1.4 Gram per Liter (G/L) Standard Deviation 3.64	-3.0 Gram per Liter (G/L) Standard Deviation 5.08	-2.3 Gram per Liter (G/L) Standard Deviation 6.43	-4.0 Gram per Liter (G/L) Standard Deviation 2.00	-2.0 Gram per Liter (G/L) Standard Deviation 2.16

SECONDARY outcome

Timeframe: Week 2, 4, 8, 12, 14, EW (up to week 14)

Population: Safety Population

Blood samples were collected to evaluate change from Baseline in Alk.phosph., ALT, AST and GGT values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.

Outcome measures

Outcome measures
Measure	GSK2894512 0.5% QD n=41 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=42 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=40 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	GSK2894512 1% BID n=40 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=41 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=43 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) GGT; Week 8; n= 35,37,34,38,29,28	-0.5 International unit per liter (IU/L) Standard Deviation 6.96	-0.2 International unit per liter (IU/L) Standard Deviation 11.68	0.4 International unit per liter (IU/L) Standard Deviation 5.73	-2.0 International unit per liter (IU/L) Standard Deviation 14.19	-1.2 International unit per liter (IU/L) Standard Deviation 4.80	1.6 International unit per liter (IU/L) Standard Deviation 10.32
Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) ALT; Week 12; n= 36,37,32,35,28,28	-0.6 International unit per liter (IU/L) Standard Deviation 4.64	0.8 International unit per liter (IU/L) Standard Deviation 7.97	-0.2 International unit per liter (IU/L) Standard Deviation 5.58	-0.3 International unit per liter (IU/L) Standard Deviation 12.51	-3.1 International unit per liter (IU/L) Standard Deviation 4.78	-1.4 International unit per liter (IU/L) Standard Deviation 4.13
Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) ALT; Week 14; n= 33,35,32,34,31,29	-1.0 International unit per liter (IU/L) Standard Deviation 3.93	-0.5 International unit per liter (IU/L) Standard Deviation 5.58	-0.8 International unit per liter (IU/L) Standard Deviation 3.15	3.3 International unit per liter (IU/L) Standard Deviation 24.10	-3.2 International unit per liter (IU/L) Standard Deviation 5.47	-0.9 International unit per liter (IU/L) Standard Deviation 4.51
Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Alk.Phosph.; Week 2; n= 38,39,38,39,33,32	-2.3 International unit per liter (IU/L) Standard Deviation 13.49	-2.3 International unit per liter (IU/L) Standard Deviation 15.32	-2.0 International unit per liter (IU/L) Standard Deviation 8.70	3.7 International unit per liter (IU/L) Standard Deviation 14.58	-1.7 International unit per liter (IU/L) Standard Deviation 12.24	3.7 International unit per liter (IU/L) Standard Deviation 21.04
Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Alk.Phosph.; Week 4; n= 38,39,38,38,30,32	-2.7 International unit per liter (IU/L) Standard Deviation 12.36	-3.8 International unit per liter (IU/L) Standard Deviation 16.24	-3.9 International unit per liter (IU/L) Standard Deviation 9.79	2.1 International unit per liter (IU/L) Standard Deviation 15.59	-0.4 International unit per liter (IU/L) Standard Deviation 12.17	1.7 International unit per liter (IU/L) Standard Deviation 15.22
Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Alk.Phosph.; Week 8; n= 35,37,34,38,29,28	-4.8 International unit per liter (IU/L) Standard Deviation 18.15	-1.6 International unit per liter (IU/L) Standard Deviation 19.08	-5.7 International unit per liter (IU/L) Standard Deviation 12.03	2.0 International unit per liter (IU/L) Standard Deviation 12.40	-0.7 International unit per liter (IU/L) Standard Deviation 9.39	-1.2 International unit per liter (IU/L) Standard Deviation 12.85
Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Alk.Phosph.; Week 12; n= 36,37,32,35,28,28	-6.3 International unit per liter (IU/L) Standard Deviation 17.29	-8.1 International unit per liter (IU/L) Standard Deviation 21.60	-7.8 International unit per liter (IU/L) Standard Deviation 15.34	3.1 International unit per liter (IU/L) Standard Deviation 15.36	-0.4 International unit per liter (IU/L) Standard Deviation 10.14	-5.1 International unit per liter (IU/L) Standard Deviation 18.47
Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Alk. Phosph.; Week 14; n= 33,35,32,34,31,29	-7.2 International unit per liter (IU/L) Standard Deviation 20.07	-6.5 International unit per liter (IU/L) Standard Deviation 24.86	-8.3 International unit per liter (IU/L) Standard Deviation 14.83	-1.4 International unit per liter (IU/L) Standard Deviation 13.46	-3.0 International unit per liter (IU/L) Standard Deviation 17.56	-7.2 International unit per liter (IU/L) Standard Deviation 19.31
Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Alk.Phosph.; EW; n= 3,3,7,3,11,11	0.3 International unit per liter (IU/L) Standard Deviation 9.87	0.9 International unit per liter (IU/L) Standard Deviation 6.74	-0.5 International unit per liter (IU/L) Standard Deviation 7.39	-2.3 International unit per liter (IU/L) Standard Deviation 27.74	5.3 International unit per liter (IU/L) Standard Deviation 12.50	8.0 International unit per liter (IU/L) Standard Deviation 18.13
Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) ALT; Week 2; n= 38,39,38,39,33,32	1.5 International unit per liter (IU/L) Standard Deviation 12.52	0.2 International unit per liter (IU/L) Standard Deviation 7.21	0.2 International unit per liter (IU/L) Standard Deviation 6.06	3.6 International unit per liter (IU/L) Standard Deviation 21.02	-1.8 International unit per liter (IU/L) Standard Deviation 3.92	7.7 International unit per liter (IU/L) Standard Deviation 28.01
Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) ALT; Week 4; n= 38,39,38,38,30,32	1.7 International unit per liter (IU/L) Standard Deviation 9.28	0.3 International unit per liter (IU/L) Standard Deviation 7.63	0.6 International unit per liter (IU/L) Standard Deviation 4.55	-0.8 International unit per liter (IU/L) Standard Deviation 9.20	-1.1 International unit per liter (IU/L) Standard Deviation 5.23	2.7 International unit per liter (IU/L) Standard Deviation 8.07
Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) ALT; Week 8; n= 35,37,34,38,29,28	-1.5 International unit per liter (IU/L) Standard Deviation 3.98	-2.0 International unit per liter (IU/L) Standard Deviation 6.06	0.3 International unit per liter (IU/L) Standard Deviation 5.16	4.9 International unit per liter (IU/L) Standard Deviation 30.93	-1.4 International unit per liter (IU/L) Standard Deviation 7.00	1.2 International unit per liter (IU/L) Standard Deviation 6.77
Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) ALT; EW; n= 3,3,7,3,11,11	2.0 International unit per liter (IU/L) Standard Deviation 6.56	-1.7 International unit per liter (IU/L) Standard Deviation 4.73	3.3 International unit per liter (IU/L) Standard Deviation 7.70	13.0 International unit per liter (IU/L) Standard Deviation 37.64	-3.7 International unit per liter (IU/L) Standard Deviation 16.62	11.3 International unit per liter (IU/L) Standard Deviation 36.60
Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) AST; Week 2; n= 38,39,38,39,33,32	0.2 International unit per liter (IU/L) Standard Deviation 4.99	-0.8 International unit per liter (IU/L) Standard Deviation 4.99	0.5 International unit per liter (IU/L) Standard Deviation 3.54	1.6 International unit per liter (IU/L) Standard Deviation 9.36	-1.3 International unit per liter (IU/L) Standard Deviation 2.98	3.1 International unit per liter (IU/L) Standard Deviation 13.84
Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) AST; Week 4; n=38,39,38,38,30,32	1.1 International unit per liter (IU/L) Standard Deviation 6.81	0.0 International unit per liter (IU/L) Standard Deviation 5.68	0.5 International unit per liter (IU/L) Standard Deviation 4.17	-0.4 International unit per liter (IU/L) Standard Deviation 5.24	-1.1 International unit per liter (IU/L) Standard Deviation 4.18	1.0 International unit per liter (IU/L) Standard Deviation 6.37
Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) AST; Week 8; n= 35,37,34,38,29,28	-1.1 International unit per liter (IU/L) Standard Deviation 4.56	-1.9 International unit per liter (IU/L) Standard Deviation 6.05	-0.1 International unit per liter (IU/L) Standard Deviation 5.80	18.4 International unit per liter (IU/L) Standard Deviation 97.92	-0.9 International unit per liter (IU/L) Standard Deviation 5.06	0.2 International unit per liter (IU/L) Standard Deviation 4.80
Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) AST; Week 12; n=36,37,32,35,28,28	-0.7 International unit per liter (IU/L) Standard Deviation 4.90	0.9 International unit per liter (IU/L) Standard Deviation 6.88	0.2 International unit per liter (IU/L) Standard Deviation 5.20	0.1 International unit per liter (IU/L) Standard Deviation 8.54	-1.2 International unit per liter (IU/L) Standard Deviation 4.67	-1.3 International unit per liter (IU/L) Standard Deviation 5.12
Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) AST; Week 14; n= 33,35,32,34,31,29	-1.1 International unit per liter (IU/L) Standard Deviation 3.48	0.5 International unit per liter (IU/L) Standard Deviation 8.12	0.0 International unit per liter (IU/L) Standard Deviation 4.49	4.4 International unit per liter (IU/L) Standard Deviation 28.19	-2.2 International unit per liter (IU/L) Standard Deviation 4.89	-1.3 International unit per liter (IU/L) Standard Deviation 3.92
Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) AST; EW; n= 3,3,7,3,11,11	3.0 International unit per liter (IU/L) Standard Deviation 1.73	-0.8 International unit per liter (IU/L) Standard Deviation 2.14	3.1 International unit per liter (IU/L) Standard Deviation 6.30	4.7 International unit per liter (IU/L) Standard Deviation 8.62	1.7 International unit per liter (IU/L) Standard Deviation 14.57	4.0 International unit per liter (IU/L) Standard Deviation 12.83
Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) GGT; Week 2; n= 38,39,38,39,33,32	0.7 International unit per liter (IU/L) Standard Deviation 3.49	-0.9 International unit per liter (IU/L) Standard Deviation 8.04	-2.9 International unit per liter (IU/L) Standard Deviation 9.86	-0.3 International unit per liter (IU/L) Standard Deviation 6.36	-1.3 International unit per liter (IU/L) Standard Deviation 4.61	4.0 International unit per liter (IU/L) Standard Deviation 13.82
Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) GGT; Week 4; n= 38,39,38,38,30,32	0.9 International unit per liter (IU/L) Standard Deviation 4.87	0.1 International unit per liter (IU/L) Standard Deviation 10.95	-1.0 International unit per liter (IU/L) Standard Deviation 4.79	-2.1 International unit per liter (IU/L) Standard Deviation 9.47	-0.8 International unit per liter (IU/L) Standard Deviation 4.01	1.3 International unit per liter (IU/L) Standard Deviation 6.38
Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) GGT; Week 12; n= 36,37,32,35,28,28	1.1 International unit per liter (IU/L) Standard Deviation 4.52	1.7 International unit per liter (IU/L) Standard Deviation 11.65	1.9 International unit per liter (IU/L) Standard Deviation 7.12	-1.8 International unit per liter (IU/L) Standard Deviation 14.77	-1.6 International unit per liter (IU/L) Standard Deviation 4.05	0.8 International unit per liter (IU/L) Standard Deviation 8.38
Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) GGT; Week 14; n= 33,35,32,34,31,29	1.0 International unit per liter (IU/L) Standard Deviation 3.63	0.1 International unit per liter (IU/L) Standard Deviation 8.19	-0.3 International unit per liter (IU/L) Standard Deviation 3.07	-2.2 International unit per liter (IU/L) Standard Deviation 15.76	-1.0 International unit per liter (IU/L) Standard Deviation 3.43	0.7 International unit per liter (IU/L) Standard Deviation 4.93
Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) GGT; EW; n= 3,3,7,3,11,11	-0.7 International unit per liter (IU/L) Standard Deviation 7.23	-1.9 International unit per liter (IU/L) Standard Deviation 8.19	-4.8 International unit per liter (IU/L) Standard Deviation 17.11	5.7 International unit per liter (IU/L) Standard Deviation 31.01	-8.0 International unit per liter (IU/L) Standard Deviation 16.52	3.7 International unit per liter (IU/L) Standard Deviation 9.48

SECONDARY outcome

Timeframe: Week 2, 4, 8, 12, 14, EW (up to week 14)

Population: Safety Population

Blood samples were collected to evaluate change from Baseline in direct and total bilirubin, creatinine and urate values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.

Outcome measures

Outcome measures
Measure	GSK2894512 0.5% QD n=41 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=42 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=40 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	GSK2894512 1% BID n=40 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=41 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=43 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate Total bilirubin; EW; n = 3,3,7,3,11,11	-0.7 Micromoles per liter (µmol/L) Standard Deviation 1.15	0.5 Micromoles per liter (µmol/L) Standard Deviation 4.82	-0.4 Micromoles per liter (µmol/L) Standard Deviation 4.27	-1.3 Micromoles per liter (µmol/L) Standard Deviation 5.77	-2.0 Micromoles per liter (µmol/L) Standard Deviation 2.00	-0.9 Micromoles per liter (µmol/L) Standard Deviation 3.44
Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate Creatinine; Week 2; n= 38,39,38,39,33,32	-0.84 Micromoles per liter (µmol/L) Standard Deviation 7.294	-1.56 Micromoles per liter (µmol/L) Standard Deviation 10.461	0.11 Micromoles per liter (µmol/L) Standard Deviation 8.059	-3.00 Micromoles per liter (µmol/L) Standard Deviation 10.771	-3.65 Micromoles per liter (µmol/L) Standard Deviation 6.186	-3.46 Micromoles per liter (µmol/L) Standard Deviation 7.165
Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate Urate; Week 2; n= 38,39,38,39,33,32	7.9 Micromoles per liter (µmol/L) Standard Deviation 49.96	0.0 Micromoles per liter (µmol/L) Standard Deviation 50.19	2.5 Micromoles per liter (µmol/L) Standard Deviation 38.44	-26.1 Micromoles per liter (µmol/L) Standard Deviation 74.09	-7.9 Micromoles per liter (µmol/L) Standard Deviation 41.56	-14.5 Micromoles per liter (µmol/L) Standard Deviation 43.91
Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate Urate; Week 4; n=38,39,38,38,30,32	3.9 Micromoles per liter (µmol/L) Standard Deviation 59.84	-2.7 Micromoles per liter (µmol/L) Standard Deviation 62.69	24.1 Micromoles per liter (µmol/L) Standard Deviation 62.21	-18.7 Micromoles per liter (µmol/L) Standard Deviation 58.92	-8.7 Micromoles per liter (µmol/L) Standard Deviation 39.21	-2.9 Micromoles per liter (µmol/L) Standard Deviation 52.96
Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate Urate; Week 8; n=35,37,34, 38,29,28	-5.5 Micromoles per liter (µmol/L) Standard Deviation 59.76	12.8 Micromoles per liter (µmol/L) Standard Deviation 44.07	12.9 Micromoles per liter (µmol/L) Standard Deviation 59.25	-20.0 Micromoles per liter (µmol/L) Standard Deviation 60.44	-0.5 Micromoles per liter (µmol/L) Standard Deviation 52.54	-7.9 Micromoles per liter (µmol/L) Standard Deviation 51.63
Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate Urate; Week 12; n=36,37,32,35,28,28	2.6 Micromoles per liter (µmol/L) Standard Deviation 60.89	6.8 Micromoles per liter (µmol/L) Standard Deviation 51.43	5.0 Micromoles per liter (µmol/L) Standard Deviation 46.79	-20.8 Micromoles per liter (µmol/L) Standard Deviation 70.48	-5.1 Micromoles per liter (µmol/L) Standard Deviation 93.20	-14.7 Micromoles per liter (µmol/L) Standard Deviation 46.97
Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate Urate; Week 14; n=33,35,32,34,31,29	15.9 Micromoles per liter (µmol/L) Standard Deviation 61.50	5.2 Micromoles per liter (µmol/L) Standard Deviation 56.32	17.2 Micromoles per liter (µmol/L) Standard Deviation 43.33	-10.9 Micromoles per liter (µmol/L) Standard Deviation 58.44	-5.4 Micromoles per liter (µmol/L) Standard Deviation 46.86	3.8 Micromoles per liter (µmol/L) Standard Deviation 48.64
Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate Urate; EW; n=3,3,7,3,11,11	-16.7 Micromoles per liter (µmol/L) Standard Deviation 85.05	0.9 Micromoles per liter (µmol/L) Standard Deviation 42.30	8.2 Micromoles per liter (µmol/L) Standard Deviation 43.55	-6.7 Micromoles per liter (µmol/L) Standard Deviation 20.82	-16.7 Micromoles per liter (µmol/L) Standard Deviation 15.28	-22.9 Micromoles per liter (µmol/L) Standard Deviation 39.46
Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate Direct bilirubin; Week 2; n= 38,39,38,39,33,32	-0.1 Micromoles per liter (µmol/L) Standard Deviation 1.07	0.0 Micromoles per liter (µmol/L) Standard Deviation 1.66	-0.3 Micromoles per liter (µmol/L) Standard Deviation 1.15	-0.1 Micromoles per liter (µmol/L) Standard Deviation 0.98	-0.3 Micromoles per liter (µmol/L) Standard Deviation 1.08	-0.5 Micromoles per liter (µmol/L) Standard Deviation 1.18
Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate Direct bilirubin; Week 4; n= 38,39,38,38,30,32	-0.2 Micromoles per liter (µmol/L) Standard Deviation 1.02	0.1 Micromoles per liter (µmol/L) Standard Deviation 1.23	-0.4 Micromoles per liter (µmol/L) Standard Deviation 0.94	-0.1 Micromoles per liter (µmol/L) Standard Deviation 1.18	-0.3 Micromoles per liter (µmol/L) Standard Deviation 0.82	-0.5 Micromoles per liter (µmol/L) Standard Deviation 1.18
Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate Direct bilirubin; Week 8; n= 35,37,34, 38,29,28	-0.2 Micromoles per liter (µmol/L) Standard Deviation 1.26	0.1 Micromoles per liter (µmol/L) Standard Deviation 1.36	-0.5 Micromoles per liter (µmol/L) Standard Deviation 1.17	0.1 Micromoles per liter (µmol/L) Standard Deviation 1.41	-0.2 Micromoles per liter (µmol/L) Standard Deviation 0.99	-0.4 Micromoles per liter (µmol/L) Standard Deviation 1.08
Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate Direct bilirubin; Week 12; n= 36,37,32,35,28,28	-0.2 Micromoles per liter (µmol/L) Standard Deviation 1.17	0.0 Micromoles per liter (µmol/L) Standard Deviation 1.33	-0.1 Micromoles per liter (µmol/L) Standard Deviation 1.21	0.3 Micromoles per liter (µmol/L) Standard Deviation 1.19	0.0 Micromoles per liter (µmol/L) Standard Deviation 1.15	-0.4 Micromoles per liter (µmol/L) Standard Deviation 0.94
Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate Direct bilirubin; Week 14; n= 33,35,32,34,31,29	-0.2 Micromoles per liter (µmol/L) Standard Deviation 1.07	0.0 Micromoles per liter (µmol/L) Standard Deviation 1.26	-0.3 Micromoles per liter (µmol/L) Standard Deviation 1.58	-0.1 Micromoles per liter (µmol/L) Standard Deviation 1.17	-0.2 Micromoles per liter (µmol/L) Standard Deviation 1.32	0.1 Micromoles per liter (µmol/L) Standard Deviation 1.19
Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate Direct bilirubin; EW; n= 3,3,7,3,11,11	-0.7 Micromoles per liter (µmol/L) Standard Deviation 1.15	-0.5 Micromoles per liter (µmol/L) Standard Deviation 1.81	0.0 Micromoles per liter (µmol/L) Standard Deviation 1.26	0.0 Micromoles per liter (µmol/L) Standard Deviation 2.00	-0.7 Micromoles per liter (µmol/L) Standard Deviation 1.15	-0.6 Micromoles per liter (µmol/L) Standard Deviation 0.98
Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate Total bilirubin; Week 2; n=38,39,38,39,33,32	-0.6 Micromoles per liter (µmol/L) Standard Deviation 2.64	-0.4 Micromoles per liter (µmol/L) Standard Deviation 5.49	-0.1 Micromoles per liter (µmol/L) Standard Deviation 2.80	-1.1 Micromoles per liter (µmol/L) Standard Deviation 3.21	-0.8 Micromoles per liter (µmol/L) Standard Deviation 3.23	-2.2 Micromoles per liter (µmol/L) Standard Deviation 3.37
Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate Total bilirubin; Week 4; n= 38,39,38,38,30,32	-1.4 Micromoles per liter (µmol/L) Standard Deviation 3.15	0.3 Micromoles per liter (µmol/L) Standard Deviation 4.27	0.0 Micromoles per liter (µmol/L) Standard Deviation 2.16	-1.2 Micromoles per liter (µmol/L) Standard Deviation 3.18	-0.8 Micromoles per liter (µmol/L) Standard Deviation 2.54	-1.5 Micromoles per liter (µmol/L) Standard Deviation 3.11
Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate Total bilirubin; Week 8; n= 35,37,34, 38,29,28	-0.8 Micromoles per liter (µmol/L) Standard Deviation 4.50	-0.1 Micromoles per liter (µmol/L) Standard Deviation 5.06	-1.1 Micromoles per liter (µmol/L) Standard Deviation 2.14	0.0 Micromoles per liter (µmol/L) Standard Deviation 4.97	-0.3 Micromoles per liter (µmol/L) Standard Deviation 2.93	-1.8 Micromoles per liter (µmol/L) Standard Deviation 3.24
Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate Total bilirubin; Weel 12; n= 36,37,32,35,28,28	-0.9 Micromoles per liter (µmol/L) Standard Deviation 3.30	0.6 Micromoles per liter (µmol/L) Standard Deviation 4.42	-0.1 Micromoles per liter (µmol/L) Standard Deviation 3.17	0.5 Micromoles per liter (µmol/L) Standard Deviation 4.15	0.1 Micromoles per liter (µmol/L) Standard Deviation 2.26	-1.9 Micromoles per liter (µmol/L) Standard Deviation 2.56
Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate Total bilirubin; Week 14; n= 33,35,32,34,31,29	-0.6 Micromoles per liter (µmol/L) Standard Deviation 3.43	0.1 Micromoles per liter (µmol/L) Standard Deviation 3.92	-0.4 Micromoles per liter (µmol/L) Standard Deviation 4.19	-0.1 Micromoles per liter (µmol/L) Standard Deviation 2.81	-0.4 Micromoles per liter (µmol/L) Standard Deviation 3.90	0.0 Micromoles per liter (µmol/L) Standard Deviation 4.10
Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate Creatinine; Week 4; n= 38,39,38,38,30,32	0.51 Micromoles per liter (µmol/L) Standard Deviation 8.990	-1.19 Micromoles per liter (µmol/L) Standard Deviation 10.945	3.70 Micromoles per liter (µmol/L) Standard Deviation 14.019	-0.04 Micromoles per liter (µmol/L) Standard Deviation 11.471	-3.30 Micromoles per liter (µmol/L) Standard Deviation 6.974	-1.14 Micromoles per liter (µmol/L) Standard Deviation 7.897
Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate Creatinine; Week 8; n= 35,37,34, 38,29,28	-0.04 Micromoles per liter (µmol/L) Standard Deviation 8.114	-0.58 Micromoles per liter (µmol/L) Standard Deviation 11.799	-0.51 Micromoles per liter (µmol/L) Standard Deviation 7.530	-2.03 Micromoles per liter (µmol/L) Standard Deviation 12.571	-1.70 Micromoles per liter (µmol/L) Standard Deviation 8.249	-0.29 Micromoles per liter (µmol/L) Standard Deviation 8.357
Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate Creatinine; Week 12; n= 36,37,32,35,28,28	1.03 Micromoles per liter (µmol/L) Standard Deviation 7.618	-0.70 Micromoles per liter (µmol/L) Standard Deviation 10.789	1.58 Micromoles per liter (µmol/L) Standard Deviation 6.241	-1.84 Micromoles per liter (µmol/L) Standard Deviation 11.918	-1.41 Micromoles per liter (µmol/L) Standard Deviation 9.573	0.16 Micromoles per liter (µmol/L) Standard Deviation 5.886
Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate Creatinine; Week 14; n= 33,35,32,34,31,29	3.17 Micromoles per liter (µmol/L) Standard Deviation 7.990	-0.05 Micromoles per liter (µmol/L) Standard Deviation 7.859	1.52 Micromoles per liter (µmol/L) Standard Deviation 5.860	2.04 Micromoles per liter (µmol/L) Standard Deviation 10.306	-1.48 Micromoles per liter (µmol/L) Standard Deviation 9.986	2.77 Micromoles per liter (µmol/L) Standard Deviation 7.351
Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate Creatinine; EW; n=3,3,7,3,11,11	-4.13 Micromoles per liter (µmol/L) Standard Deviation 8.251	-1.35 Micromoles per liter (µmol/L) Standard Deviation 8.386	0.09 Micromoles per liter (µmol/L) Standard Deviation 11.172	1.20 Micromoles per liter (µmol/L) Standard Deviation 2.651	-5.33 Micromoles per liter (µmol/L) Standard Deviation 2.650	-8.19 Micromoles per liter (µmol/L) Standard Deviation 9.071

SECONDARY outcome

Timeframe: Week 2, 4, 8, 12, 14, EW (up to week 14)

Population: Safety Population

Blood samples were collected to evaluate change from Baseline in calcium, chloride, CO2, glucose, potassium, sodium and BUN values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.

Outcome measures

Outcome measures
Measure	GSK2894512 0.5% QD n=41 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=42 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=40 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	GSK2894512 1% BID n=40 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=41 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=43 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Glucose; Week 4; n= 38,39,38,38,30,32	0.64 Millimoles per liter (mmol/L) Standard Deviation 1.209	0.38 Millimoles per liter (mmol/L) Standard Deviation 1.154	-0.00 Millimoles per liter (mmol/L) Standard Deviation 3.164	0.53 Millimoles per liter (mmol/L) Standard Deviation 1.334	0.25 Millimoles per liter (mmol/L) Standard Deviation 1.101	0.02 Millimoles per liter (mmol/L) Standard Deviation 1.089
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Glucose; Week 12; n= 36,37,32,35,28,28	0.36 Millimoles per liter (mmol/L) Standard Deviation 1.077	0.50 Millimoles per liter (mmol/L) Standard Deviation 1.028	-0.49 Millimoles per liter (mmol/L) Standard Deviation 3.240	0.22 Millimoles per liter (mmol/L) Standard Deviation 1.664	0.16 Millimoles per liter (mmol/L) Standard Deviation 0.990	0.01 Millimoles per liter (mmol/L) Standard Deviation 1.097
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Chloride; Week 2; n= 38,39,38,39,33,32	0.6 Millimoles per liter (mmol/L) Standard Deviation 2.22	-0.5 Millimoles per liter (mmol/L) Standard Deviation 2.49	0.4 Millimoles per liter (mmol/L) Standard Deviation 2.27	0.5 Millimoles per liter (mmol/L) Standard Deviation 2.68	0.9 Millimoles per liter (mmol/L) Standard Deviation 2.32	0.2 Millimoles per liter (mmol/L) Standard Deviation 2.68
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Calcium; Week 2; n= 38,39,38,39,33,32	-0.022 Millimoles per liter (mmol/L) Standard Deviation 0.0822	-0.024 Millimoles per liter (mmol/L) Standard Deviation 0.1346	-0.027 Millimoles per liter (mmol/L) Standard Deviation 0.0758	-0.042 Millimoles per liter (mmol/L) Standard Deviation 0.0941	-0.037 Millimoles per liter (mmol/L) Standard Deviation 0.0918	-0.067 Millimoles per liter (mmol/L) Standard Deviation 0.0970
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) BUN; Week 4; n=38,39,38,38,30,32	-0.08 Millimoles per liter (mmol/L) Standard Deviation 1.094	0.10 Millimoles per liter (mmol/L) Standard Deviation 1.367	-0.11 Millimoles per liter (mmol/L) Standard Deviation 1.091	-0.38 Millimoles per liter (mmol/L) Standard Deviation 1.142	-0.21 Millimoles per liter (mmol/L) Standard Deviation 1.276	0.00 Millimoles per liter (mmol/L) Standard Deviation 1.202
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Chloride; Week 4; n=38,39,38,38,30,32	0.3 Millimoles per liter (mmol/L) Standard Deviation 2.26	-0.4 Millimoles per liter (mmol/L) Standard Deviation 2.01	0.5 Millimoles per liter (mmol/L) Standard Deviation 2.38	0.5 Millimoles per liter (mmol/L) Standard Deviation 2.54	0.1 Millimoles per liter (mmol/L) Standard Deviation 2.31	0.5 Millimoles per liter (mmol/L) Standard Deviation 2.05
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Calcium; Week 4; n= 38,39,38,38,30,32	-0.028 Millimoles per liter (mmol/L) Standard Deviation 0.0840	-0.031 Millimoles per liter (mmol/L) Standard Deviation 0.0952	-0.031 Millimoles per liter (mmol/L) Standard Deviation 0.0900	-0.037 Millimoles per liter (mmol/L) Standard Deviation 0.1076	-0.014 Millimoles per liter (mmol/L) Standard Deviation 0.0899	-0.050 Millimoles per liter (mmol/L) Standard Deviation 0.0873
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Calcium; Week 8; n=35,37,34,38,29,28	-0.025 Millimoles per liter (mmol/L) Standard Deviation 0.0754	-0.035 Millimoles per liter (mmol/L) Standard Deviation 0.0989	-0.038 Millimoles per liter (mmol/L) Standard Deviation 0.0788	-0.053 Millimoles per liter (mmol/L) Standard Deviation 0.0939	-0.024 Millimoles per liter (mmol/L) Standard Deviation 0.0973	-0.063 Millimoles per liter (mmol/L) Standard Deviation 0.0800
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Calcium; Week 12; n=36,37,32,35,28,28	-0.029 Millimoles per liter (mmol/L) Standard Deviation 0.0911	-0.026 Millimoles per liter (mmol/L) Standard Deviation 0.1112	-0.004 Millimoles per liter (mmol/L) Standard Deviation 0.0596	-0.022 Millimoles per liter (mmol/L) Standard Deviation 0.0928	-0.028 Millimoles per liter (mmol/L) Standard Deviation 0.0861	-0.061 Millimoles per liter (mmol/L) Standard Deviation 0.0934
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Calcium; Week 14; n=33,35,32,34,31,29	-0.019 Millimoles per liter (mmol/L) Standard Deviation 0.0868	-0.028 Millimoles per liter (mmol/L) Standard Deviation 0.0897	-0.024 Millimoles per liter (mmol/L) Standard Deviation 0.0668	-0.022 Millimoles per liter (mmol/L) Standard Deviation 0.0793	-0.019 Millimoles per liter (mmol/L) Standard Deviation 0.0787	-0.037 Millimoles per liter (mmol/L) Standard Deviation 0.0964
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Calcium; EW; n= 3,3,7,3,11,11	-0.047 Millimoles per liter (mmol/L) Standard Deviation 0.0503	-0.025 Millimoles per liter (mmol/L) Standard Deviation 0.1092	-0.038 Millimoles per liter (mmol/L) Standard Deviation 0.0914	-0.073 Millimoles per liter (mmol/L) Standard Deviation 0.1102	-0.053 Millimoles per liter (mmol/L) Standard Deviation 0.1405	-0.003 Millimoles per liter (mmol/L) Standard Deviation 0.1122
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Chloride; Week 8; n= 35,37,34,38,29,28	-0.3 Millimoles per liter (mmol/L) Standard Deviation 2.45	-0.4 Millimoles per liter (mmol/L) Standard Deviation 2.21	0.5 Millimoles per liter (mmol/L) Standard Deviation 2.86	1.0 Millimoles per liter (mmol/L) Standard Deviation 2.32	0.5 Millimoles per liter (mmol/L) Standard Deviation 1.99	0.5 Millimoles per liter (mmol/L) Standard Deviation 2.27
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Chloride; Week 12; n= 36,37,32,35,28,28	0.5 Millimoles per liter (mmol/L) Standard Deviation 2.44	-0.4 Millimoles per liter (mmol/L) Standard Deviation 1.83	-0.1 Millimoles per liter (mmol/L) Standard Deviation 2.76	0.1 Millimoles per liter (mmol/L) Standard Deviation 2.57	0.7 Millimoles per liter (mmol/L) Standard Deviation 2.31	0.3 Millimoles per liter (mmol/L) Standard Deviation 1.85
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Chloride; Week 14; n=33,35,32,34,31,29	-0.1 Millimoles per liter (mmol/L) Standard Deviation 2.40	-0.3 Millimoles per liter (mmol/L) Standard Deviation 2.32	0.6 Millimoles per liter (mmol/L) Standard Deviation 2.64	0.9 Millimoles per liter (mmol/L) Standard Deviation 2.34	0.4 Millimoles per liter (mmol/L) Standard Deviation 1.82	0.1 Millimoles per liter (mmol/L) Standard Deviation 2.87
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Chloride; EW; n= 3,3,7,3,11,11	1.0 Millimoles per liter (mmol/L) Standard Deviation 2.00	0.1 Millimoles per liter (mmol/L) Standard Deviation 1.70	0.6 Millimoles per liter (mmol/L) Standard Deviation 2.66	-1.0 Millimoles per liter (mmol/L) Standard Deviation 1.00	1.3 Millimoles per liter (mmol/L) Standard Deviation 1.53	0.3 Millimoles per liter (mmol/L) Standard Deviation 1.98
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) CO2; Week 2; n= 38,39,38,39,33,32	-0.4 Millimoles per liter (mmol/L) Standard Deviation 2.47	-0.9 Millimoles per liter (mmol/L) Standard Deviation 2.39	-1.0 Millimoles per liter (mmol/L) Standard Deviation 2.15	-1.8 Millimoles per liter (mmol/L) Standard Deviation 2.04	-0.8 Millimoles per liter (mmol/L) Standard Deviation 2.52	-1.2 Millimoles per liter (mmol/L) Standard Deviation 2.30
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) CO2; Week 4; n= 38,39,38,38,30,32	-0.7 Millimoles per liter (mmol/L) Standard Deviation 2.22	-0.5 Millimoles per liter (mmol/L) Standard Deviation 2.71	-1.0 Millimoles per liter (mmol/L) Standard Deviation 2.06	-1.4 Millimoles per liter (mmol/L) Standard Deviation 1.98	-0.8 Millimoles per liter (mmol/L) Standard Deviation 3.07	-1.3 Millimoles per liter (mmol/L) Standard Deviation 2.14
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) CO2; Week 14; n=33,35,32,34,31,29	-0.6 Millimoles per liter (mmol/L) Standard Deviation 3.13	-0.9 Millimoles per liter (mmol/L) Standard Deviation 2.29	-1.3 Millimoles per liter (mmol/L) Standard Deviation 1.86	-1.1 Millimoles per liter (mmol/L) Standard Deviation 2.23	-0.8 Millimoles per liter (mmol/L) Standard Deviation 3.09	-1.3 Millimoles per liter (mmol/L) Standard Deviation 2.59
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) CO2; Week 8; n= 35,37,34,38,29,28	-0.7 Millimoles per liter (mmol/L) Standard Deviation 2.60	-0.8 Millimoles per liter (mmol/L) Standard Deviation 2.43	-1.8 Millimoles per liter (mmol/L) Standard Deviation 2.65	-1.9 Millimoles per liter (mmol/L) Standard Deviation 2.34	-1.1 Millimoles per liter (mmol/L) Standard Deviation 3.35	-1.1 Millimoles per liter (mmol/L) Standard Deviation 2.21
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) CO2; EW; n=3,3,7,3,11,11	0.3 Millimoles per liter (mmol/L) Standard Deviation 1.53	0.0 Millimoles per liter (mmol/L) Standard Deviation 2.19	-0.4 Millimoles per liter (mmol/L) Standard Deviation 1.80	0.0 Millimoles per liter (mmol/L) Standard Deviation 1.00	-0.3 Millimoles per liter (mmol/L) Standard Deviation 2.08	-1.9 Millimoles per liter (mmol/L) Standard Deviation 3.18
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) CO2; Week 12; n=36,37,32,35,28,28	-0.7 Millimoles per liter (mmol/L) Standard Deviation 2.10	-0.5 Millimoles per liter (mmol/L) Standard Deviation 2.49	-1.1 Millimoles per liter (mmol/L) Standard Deviation 2.07	-1.1 Millimoles per liter (mmol/L) Standard Deviation 2.12	-1.0 Millimoles per liter (mmol/L) Standard Deviation 3.20	-1.1 Millimoles per liter (mmol/L) Standard Deviation 2.45
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Glucose; Week 2; n=38,39,38,39,33,32	0.37 Millimoles per liter (mmol/L) Standard Deviation 1.431	0.46 Millimoles per liter (mmol/L) Standard Deviation 0.687	-0.10 Millimoles per liter (mmol/L) Standard Deviation 3.059	0.55 Millimoles per liter (mmol/L) Standard Deviation 1.710	0.65 Millimoles per liter (mmol/L) Standard Deviation 1.384	0.13 Millimoles per liter (mmol/L) Standard Deviation 1.084
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Glucose; Week 8; n=35,37,34,38,29,28	0.51 Millimoles per liter (mmol/L) Standard Deviation 1.106	0.44 Millimoles per liter (mmol/L) Standard Deviation 1.048	-0.34 Millimoles per liter (mmol/L) Standard Deviation 3.256	0.40 Millimoles per liter (mmol/L) Standard Deviation 1.450	0.42 Millimoles per liter (mmol/L) Standard Deviation 1.253	0.01 Millimoles per liter (mmol/L) Standard Deviation 0.942
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Glucose; Week 14; n=33,35,32,34,31,29	0.14 Millimoles per liter (mmol/L) Standard Deviation 1.482	0.12 Millimoles per liter (mmol/L) Standard Deviation 0.868	-0.52 Millimoles per liter (mmol/L) Standard Deviation 3.871	0.29 Millimoles per liter (mmol/L) Standard Deviation 1.091	0.47 Millimoles per liter (mmol/L) Standard Deviation 1.275	-0.14 Millimoles per liter (mmol/L) Standard Deviation 1.465
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Glucose; EW; n= 3,3,7,3,11,11	-0.10 Millimoles per liter (mmol/L) Standard Deviation 2.007	0.32 Millimoles per liter (mmol/L) Standard Deviation 0.873	0.11 Millimoles per liter (mmol/L) Standard Deviation 0.997	-0.30 Millimoles per liter (mmol/L) Standard Deviation 0.557	-0.70 Millimoles per liter (mmol/L) Standard Deviation 0.889	0.67 Millimoles per liter (mmol/L) Standard Deviation 1.154
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Potassium; Week 2; n= 38,39,38,39,33,32	0.03 Millimoles per liter (mmol/L) Standard Deviation 0.381	0.08 Millimoles per liter (mmol/L) Standard Deviation 0.371	0.03 Millimoles per liter (mmol/L) Standard Deviation 0.339	-0.06 Millimoles per liter (mmol/L) Standard Deviation 0.318	0.04 Millimoles per liter (mmol/L) Standard Deviation 0.360	0.04 Millimoles per liter (mmol/L) Standard Deviation 0.359
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) BUN; Week 8; n= 35,37,34,38,29,28	-0.18 Millimoles per liter (mmol/L) Standard Deviation 1.099	0.17 Millimoles per liter (mmol/L) Standard Deviation 1.159	0.02 Millimoles per liter (mmol/L) Standard Deviation 1.572	-0.27 Millimoles per liter (mmol/L) Standard Deviation 1.251	0.08 Millimoles per liter (mmol/L) Standard Deviation 1.199	-0.03 Millimoles per liter (mmol/L) Standard Deviation 0.807
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Potassium; Week 4; n= 38,39,38,38,30,32	0.01 Millimoles per liter (mmol/L) Standard Deviation 0.337	0.04 Millimoles per liter (mmol/L) Standard Deviation 0.254	0.01 Millimoles per liter (mmol/L) Standard Deviation 0.428	-0.02 Millimoles per liter (mmol/L) Standard Deviation 0.359	0.09 Millimoles per liter (mmol/L) Standard Deviation 0.446	0.19 Millimoles per liter (mmol/L) Standard Deviation 0.740
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Potassium; Week 8; n= 35,37,34,38,29,28	0.03 Millimoles per liter (mmol/L) Standard Deviation 0.316	0.04 Millimoles per liter (mmol/L) Standard Deviation 0.344	-0.06 Millimoles per liter (mmol/L) Standard Deviation 0.370	0.05 Millimoles per liter (mmol/L) Standard Deviation 0.389	0.09 Millimoles per liter (mmol/L) Standard Deviation 0.303	0.19 Millimoles per liter (mmol/L) Standard Deviation 0.765
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) BUN; Week 12; n= 36,37,32,35,28,28	0.07 Millimoles per liter (mmol/L) Standard Deviation 1.030	0.23 Millimoles per liter (mmol/L) Standard Deviation 1.384	0.07 Millimoles per liter (mmol/L) Standard Deviation 1.614	-0.38 Millimoles per liter (mmol/L) Standard Deviation 1.250	-0.09 Millimoles per liter (mmol/L) Standard Deviation 1.767	-0.05 Millimoles per liter (mmol/L) Standard Deviation 1.080
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Potassium; Week 12; n= 36,37,32,35,28,28	-0.01 Millimoles per liter (mmol/L) Standard Deviation 0.339	0.06 Millimoles per liter (mmol/L) Standard Deviation 0.398	0.01 Millimoles per liter (mmol/L) Standard Deviation 0.403	0.04 Millimoles per liter (mmol/L) Standard Deviation 0.371	0.13 Millimoles per liter (mmol/L) Standard Deviation 0.335	-0.01 Millimoles per liter (mmol/L) Standard Deviation 0.449
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Potassium; Week 14; n=33,35,32,34,31,29	0.03 Millimoles per liter (mmol/L) Standard Deviation 0.349	0.14 Millimoles per liter (mmol/L) Standard Deviation 0.503	-0.00 Millimoles per liter (mmol/L) Standard Deviation 0.348	0.09 Millimoles per liter (mmol/L) Standard Deviation 0.309	0.13 Millimoles per liter (mmol/L) Standard Deviation 0.422	0.09 Millimoles per liter (mmol/L) Standard Deviation 0.570
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Potassium; EW; n= 3,3,7,3,11,11	-0.37 Millimoles per liter (mmol/L) Standard Deviation 0.058	-0.02 Millimoles per liter (mmol/L) Standard Deviation 0.236	-0.00 Millimoles per liter (mmol/L) Standard Deviation 0.366	-0.20 Millimoles per liter (mmol/L) Standard Deviation 0.100	-0.13 Millimoles per liter (mmol/L) Standard Deviation 0.208	0.10 Millimoles per liter (mmol/L) Standard Deviation 0.252
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Sodium; Week 2; n= 38,39,38,39,33,32	-0.3 Millimoles per liter (mmol/L) Standard Deviation 2.19	-0.4 Millimoles per liter (mmol/L) Standard Deviation 1.90	-0.2 Millimoles per liter (mmol/L) Standard Deviation 1.60	-0.5 Millimoles per liter (mmol/L) Standard Deviation 2.19	0.1 Millimoles per liter (mmol/L) Standard Deviation 2.17	-0.1 Millimoles per liter (mmol/L) Standard Deviation 2.33
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Sodium; Week 4; n= 38,39,38,38,30,32	-0.9 Millimoles per liter (mmol/L) Standard Deviation 1.83	-0.3 Millimoles per liter (mmol/L) Standard Deviation 2.14	-0.1 Millimoles per liter (mmol/L) Standard Deviation 1.65	-0.1 Millimoles per liter (mmol/L) Standard Deviation 2.16	-0.5 Millimoles per liter (mmol/L) Standard Deviation 1.94	-0.2 Millimoles per liter (mmol/L) Standard Deviation 1.78
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Sodium; Week 8; n=35,37,34,38,29,28	-0.7 Millimoles per liter (mmol/L) Standard Deviation 1.94	-0.6 Millimoles per liter (mmol/L) Standard Deviation 1.84	-0.0 Millimoles per liter (mmol/L) Standard Deviation 2.50	-0.3 Millimoles per liter (mmol/L) Standard Deviation 2.19	-0.2 Millimoles per liter (mmol/L) Standard Deviation 2.75	-0.2 Millimoles per liter (mmol/L) Standard Deviation 2.21
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Sodium; Week 12; n=36,37,32,35,28,28	-0.8 Millimoles per liter (mmol/L) Standard Deviation 2.02	-0.8 Millimoles per liter (mmol/L) Standard Deviation 2.14	-0.3 Millimoles per liter (mmol/L) Standard Deviation 2.14	-0.4 Millimoles per liter (mmol/L) Standard Deviation 2.11	-0.4 Millimoles per liter (mmol/L) Standard Deviation 2.30	-0.1 Millimoles per liter (mmol/L) Standard Deviation 2.06
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Sodium; Week 14; n=33,35,32,34,31,29	-1.0 Millimoles per liter (mmol/L) Standard Deviation 2.00	-0.7 Millimoles per liter (mmol/L) Standard Deviation 2.22	-0.1 Millimoles per liter (mmol/L) Standard Deviation 1.93	0.2 Millimoles per liter (mmol/L) Standard Deviation 1.97	-0.6 Millimoles per liter (mmol/L) Standard Deviation 1.75	-0.2 Millimoles per liter (mmol/L) Standard Deviation 2.34
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Sodium; EW; n=3,3,7,3,11,11	-0.3 Millimoles per liter (mmol/L) Standard Deviation 0.58	0.1 Millimoles per liter (mmol/L) Standard Deviation 1.58	0.5 Millimoles per liter (mmol/L) Standard Deviation 2.34	-1.3 Millimoles per liter (mmol/L) Standard Deviation 1.15	-1.3 Millimoles per liter (mmol/L) Standard Deviation 2.08	-2.0 Millimoles per liter (mmol/L) Standard Deviation 1.00
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) BUN; Week 2; n= 38,39,38,39,33,32	0.10 Millimoles per liter (mmol/L) Standard Deviation 1.001	0.29 Millimoles per liter (mmol/L) Standard Deviation 1.256	-0.19 Millimoles per liter (mmol/L) Standard Deviation 1.098	-0.38 Millimoles per liter (mmol/L) Standard Deviation 1.205	-0.33 Millimoles per liter (mmol/L) Standard Deviation 1.078	0.03 Millimoles per liter (mmol/L) Standard Deviation 1.026
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) BUN; Week 14; n=33,35,32,34,31,29	0.15 Millimoles per liter (mmol/L) Standard Deviation 1.209	0.02 Millimoles per liter (mmol/L) Standard Deviation 1.268	0.19 Millimoles per liter (mmol/L) Standard Deviation 1.429	0.02 Millimoles per liter (mmol/L) Standard Deviation 1.361	0.21 Millimoles per liter (mmol/L) Standard Deviation 1.540	0.19 Millimoles per liter (mmol/L) Standard Deviation 1.148
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) BUN; EW; n= 3,3,7,3,11,11	-1.00 Millimoles per liter (mmol/L) Standard Deviation 0.866	0.50 Millimoles per liter (mmol/L) Standard Deviation 0.775	-0.23 Millimoles per liter (mmol/L) Standard Deviation 1.915	-0.33 Millimoles per liter (mmol/L) Standard Deviation 0.577	-0.50 Millimoles per liter (mmol/L) Standard Deviation 1.000	-0.36 Millimoles per liter (mmol/L) Standard Deviation 1.144

SECONDARY outcome

Timeframe: Week 2, 4, 8, 12, 14, EW (up to week 14)

Population: Safety Population

Blood samples were collected from participants for evaluation of clinical chemistry parameters by Potential Clinical Importance Criteria from Baseline to Week 14, EW and any visit post-screen. The vital signs included alk.phosph., ALT, AST, bilirubin, calcium, CO2, creatinine, glucose and potassium. Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	GSK2894512 0.5% QD n=41 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=42 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=40 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	GSK2894512 1% BID n=40 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=41 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=43 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
Number of Participants With Chemistry Data of Potential Clinical Importance Alk. Phosph.; post-screen; n= 40, 40,40,39,39,40	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Bilirubin; Week 12; n=36, 37, 32, 35, 28, 28	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Calcium; Week 8; n= 35, 37, 34, 38, 29, 28	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance CO2; Week 4; n= 38,39, 38,38,30,32	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance CO2; EW; n= 3, 3, 7, 3, 11, 11	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Creatinine; Week 14; n= 33, 35, 32, 34, 31, 29	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Glucose; Week 2; n= 38,39,38,39,33,32	3 Participants	0 Participants	2 Participants	2 Participants	2 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Potassium;EW; n= 3, 3, 7, 3, 11, 11	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Calcium; EW; n= 3, 3, 7, 3, 11, 11	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance AST; Post-screen; n= 40, 40,40,39,39,40	0 Participants	0 Participants	0 Participants	4 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Bilirubin; Baseline; n= 40,41,43,41,42,40	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Alk.Phosph;Baseline; n= 40,41,43,41,42,40	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Alk.Phosph; Week 2; n= 38,39,38,39,33,32	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Alk.Phosph.; Week 4; n= 38,39, 38,38,30,32	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Alk.Phosph.; Week 8; n= 35, 37, 34, 38, 29, 28	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Alk.Phosph.; Week 12; n= 36, 37, 32, 35, 28, 28	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Alk.Phosph.; Week 14; n= 33, 35, 32, 34, 31, 29	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Alk.Phosph.; EW; n= 3, 3, 7, 3, 11, 11	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance AST; EW; n= 3, 3, 7, 3, 11, 11	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance ALT; Baseline; n= 40,41,43,41,42,40	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance ALT; Week 2; n= 38,39,38,39,33,32	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance ALT; Week 4; n= 38,39, 38,38,30,32	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance ALT; Week 8; n=35, 37, 34, 38, 29, 28	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance ALT; Week 12; n= 36, 37, 32, 35, 28, 28	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance ALT; Week 14; n=33, 35, 32, 34, 31, 29	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance ALT; EW; n= 3, 3, 7, 3, 11, 11	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance ALT; post-screen; n= 40, 40,40,39,39,40	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	2 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance AST; Baseline; n= 40,41,43,41,42,40	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance AST; Week 2; n=38,39,38,39,33,32	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance AST; Week 4; n= 38,39, 38,38,30,32	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance AST; Week 8; n= 35, 37, 34, 38, 29, 28	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance AST; Week 12; n= 36, 37, 32, 35, 28, 28	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance AST; Week 14; n= 33, 35, 32, 34, 31, 29	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Bilirubin; Week 2; n= 38,39,38,39,33,32	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Creatinine; Week 4; n= 38,39, 38,38,30,32	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Bilirubin; Week 4; n= 38,39, 38,38,30,32	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Bilirubin; Week 8; n= 35, 37, 34, 38, 29, 28	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Bilirubin; Week 14; n= 33, 35, 32, 34, 31, 29	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Bilirubin; EW; n= 3, 3, 7, 3, 11, 11	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Creatinine; Week 8; n= 35, 37, 34, 38, 29, 28	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Bilirubin; post-screen; n= 40, 40,40,39,39,40	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Creatinine; Week 12; n= 36, 37, 32, 35, 28, 28	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Calcium; Baseline; n= 40,41,43,41,42,40	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Calcium; Week 2; n=38,39,38,39,33,32	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Calcium; Week 4; n= 38,39, 38,38,30,32	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Calcium; Week 12; n= 36, 37, 32, 35, 28, 28	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Calcium; Week 14; n= 33, 35, 32, 34, 31, 29	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Creatinine; EW; n= 3, 3, 7, 3, 11, 11	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Creatinine; post-screen; n= 40, 40,40,39,39,40	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Glucose; Baseline; n= 40,41,43,41,42,40	2 Participants	1 Participants	2 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Glucose; Week 4; n= 38,39, 38,38,30,32	2 Participants	0 Participants	3 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Glucose; Week 8; n=35, 37, 34, 38, 29, 28	2 Participants	0 Participants	2 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Glucose; Week 12; n= 36, 37, 32, 35, 28, 28	1 Participants	0 Participants	2 Participants	2 Participants	1 Participants	1 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Glucose; Week 14; n= 33, 35, 32, 34, 31, 29	3 Participants	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Glucose; EW; n= 3, 3, 7, 3, 11, 11	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Glucose; post-screen; n= 40, 40,40,39,39,40	6 Participants	0 Participants	5 Participants	4 Participants	4 Participants	1 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Potassium; Baseline; n= 40,41,43,41,42,40	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Calcium; post-screen; n= 40, 40,40,39,39,40	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance CO2; Baseline; n= 40,41,43,41,42,40	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Potassium; Week 2; n= 38,39,38,39,33,32	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Potassium; Week 4; n= 38,39, 38,38,30,32	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Potassium; Week 8; n= 35, 37, 34, 38, 29, 28	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance CO2; Week 2; n=38,39,38,39,33,32	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Potassium; n= Week 12; n= 36, 37, 32, 35, 28, 28	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Potassium; Week 14; n= 33, 35, 32, 34, 31, 29	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance CO2; Week 8; n= 35, 37, 34, 38, 29, 28	1 Participants	0 Participants	2 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance CO2; Week 12; n= 36, 37, 32, 35, 28, 28	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance CO2; Week 14; n= 33, 35, 32, 34, 31, 29	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants	2 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance CO2; Post-screen; n= 40, 40,40,39,39,40	3 Participants	1 Participants	3 Participants	3 Participants	2 Participants	4 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Potassium; post-screen; n= 40, 40,40,39,39,40	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Creatinine; Baseline; n= 40,41,43,41,42,40	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Data of Potential Clinical Importance Creatinine; Week 2; n= 38,39,38,39,33,32	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 2, 4, 8, 12, 14, EW (up to week 14)

Population: Safety Population

Blood samples were collected to evaluate change from Baseline in basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelet and leukocytes and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.

Outcome measures

Outcome measures
Measure	GSK2894512 0.5% QD n=41 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=42 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=40 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	GSK2894512 1% BID n=40 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=41 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=43 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Leukocytes; Week 4; n= 38,38,38,37,30,31	0.03 Giga cells per liter (GI/L) Standard Deviation 1.517	-0.21 Giga cells per liter (GI/L) Standard Deviation 2.221	0.34 Giga cells per liter (GI/L) Standard Deviation 1.694	0.46 Giga cells per liter (GI/L) Standard Deviation 1.913	0.40 Giga cells per liter (GI/L) Standard Deviation 1.232	-0.15 Giga cells per liter (GI/L) Standard Deviation 1.807
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Leukocytes; Week 8; n=34,36,34,37,29,27	0.47 Giga cells per liter (GI/L) Standard Deviation 1.469	-0.52 Giga cells per liter (GI/L) Standard Deviation 1.721	0.49 Giga cells per liter (GI/L) Standard Deviation 1.113	0.03 Giga cells per liter (GI/L) Standard Deviation 1.466	-0.12 Giga cells per liter (GI/L) Standard Deviation 1.257	-0.21 Giga cells per liter (GI/L) Standard Deviation 1.567
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Leukocytes; Week 14; n=33,33,32,32,31,27	0.10 Giga cells per liter (GI/L) Standard Deviation 1.705	-0.32 Giga cells per liter (GI/L) Standard Deviation 2.121	0.23 Giga cells per liter (GI/L) Standard Deviation 1.498	0.02 Giga cells per liter (GI/L) Standard Deviation 1.234	0.30 Giga cells per liter (GI/L) Standard Deviation 1.200	-0.57 Giga cells per liter (GI/L) Standard Deviation 1.142
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Leukocytes; EW; n= 3,3,7,3,10,10	1.20 Giga cells per liter (GI/L) Standard Deviation 1.127	-0.29 Giga cells per liter (GI/L) Standard Deviation 1.454	-0.16 Giga cells per liter (GI/L) Standard Deviation 2.151	-0.73 Giga cells per liter (GI/L) Standard Deviation 0.666	0.23 Giga cells per liter (GI/L) Standard Deviation 1.115	0.47 Giga cells per liter (GI/L) Standard Deviation 2.394
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Basophils; EW; n= 3,3,7,3,10,10	0.017 Giga cells per liter (GI/L) Standard Deviation 0.0115	0.011 Giga cells per liter (GI/L) Standard Deviation 0.0110	-0.005 Giga cells per liter (GI/L) Standard Deviation 0.0264	-0.000 Giga cells per liter (GI/L) Standard Deviation 0.0173	0.020 Giga cells per liter (GI/L) Standard Deviation 0.0100	0.007 Giga cells per liter (GI/L) Standard Deviation 0.0180
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Eosinophils; Week 2; n=37,38,38,37,33,31	-0.018 Giga cells per liter (GI/L) Standard Deviation 0.2325	0.064 Giga cells per liter (GI/L) Standard Deviation 0.4397	0.052 Giga cells per liter (GI/L) Standard Deviation 0.1474	-0.035 Giga cells per liter (GI/L) Standard Deviation 0.2153	0.012 Giga cells per liter (GI/L) Standard Deviation 0.1629	-0.092 Giga cells per liter (GI/L) Standard Deviation 0.2733
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Eosinophils; EW; n=3,3,7,3,10,10	0.047 Giga cells per liter (GI/L) Standard Deviation 0.0643	0.065 Giga cells per liter (GI/L) Standard Deviation 0.1905	0.062 Giga cells per liter (GI/L) Standard Deviation 0.3301	0.113 Giga cells per liter (GI/L) Standard Deviation 0.1501	0.117 Giga cells per liter (GI/L) Standard Deviation 0.1680	-0.220 Giga cells per liter (GI/L) Standard Deviation 0.3114
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Lymphocytes; Week 2; n= 37,38,38,37,33,31	0.064 Giga cells per liter (GI/L) Standard Deviation 0.3510	0.030 Giga cells per liter (GI/L) Standard Deviation 0.4724	0.018 Giga cells per liter (GI/L) Standard Deviation 0.4654	0.035 Giga cells per liter (GI/L) Standard Deviation 0.4672	0.076 Giga cells per liter (GI/L) Standard Deviation 0.5239	0.123 Giga cells per liter (GI/L) Standard Deviation 0.5263
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Lymphocytes; Week 14; n= 33,33,32,32,31,27	0.195 Giga cells per liter (GI/L) Standard Deviation 0.5632	-0.035 Giga cells per liter (GI/L) Standard Deviation 0.5757	0.184 Giga cells per liter (GI/L) Standard Deviation 0.3451	0.030 Giga cells per liter (GI/L) Standard Deviation 0.4869	0.146 Giga cells per liter (GI/L) Standard Deviation 0.5891	-0.093 Giga cells per liter (GI/L) Standard Deviation 0.6048
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Lymphocytes; EW; n= 3,3,7,3,10,10	0.450 Giga cells per liter (GI/L) Standard Deviation 0.0755	-0.021 Giga cells per liter (GI/L) Standard Deviation 0.4694	-0.225 Giga cells per liter (GI/L) Standard Deviation 0.4165	-0.317 Giga cells per liter (GI/L) Standard Deviation 0.5315	0.040 Giga cells per liter (GI/L) Standard Deviation 0.0954	-0.136 Giga cells per liter (GI/L) Standard Deviation 0.4644
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Monocytes; Week 8; n= 34,36,34,37,29,27	-0.012 Giga cells per liter (GI/L) Standard Deviation 0.1359	-0.066 Giga cells per liter (GI/L) Standard Deviation 0.1465	-0.001 Giga cells per liter (GI/L) Standard Deviation 0.1171	-0.071 Giga cells per liter (GI/L) Standard Deviation 0.1443	-0.041 Giga cells per liter (GI/L) Standard Deviation 0.1224	-0.032 Giga cells per liter (GI/L) Standard Deviation 0.1355
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Monocytes; Week 14; n=33,33,32,32,31,27	0.015 Giga cells per liter (GI/L) Standard Deviation 0.1666	-0.093 Giga cells per liter (GI/L) Standard Deviation 0.1497	0.035 Giga cells per liter (GI/L) Standard Deviation 0.1821	-0.026 Giga cells per liter (GI/L) Standard Deviation 0.1532	0.027 Giga cells per liter (GI/L) Standard Deviation 0.1427	-0.016 Giga cells per liter (GI/L) Standard Deviation 0.1446
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Neutrophils; Week 4; n=38,38,38,37,30,31	0.035 Giga cells per liter (GI/L) Standard Deviation 1.3063	-0.141 Giga cells per liter (GI/L) Standard Deviation 2.1024	0.100 Giga cells per liter (GI/L) Standard Deviation 1.4283	0.487 Giga cells per liter (GI/L) Standard Deviation 2.0425	0.253 Giga cells per liter (GI/L) Standard Deviation 1.1437	-0.058 Giga cells per liter (GI/L) Standard Deviation 1.7028
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Neutrophils; Week 8; n= 34,36,34,37,29,27	0.550 Giga cells per liter (GI/L) Standard Deviation 1.5918	-0.432 Giga cells per liter (GI/L) Standard Deviation 1.5971	0.214 Giga cells per liter (GI/L) Standard Deviation 1.1894	0.009 Giga cells per liter (GI/L) Standard Deviation 1.4215	-0.203 Giga cells per liter (GI/L) Standard Deviation 1.0365	-0.083 Giga cells per liter (GI/L) Standard Deviation 1.4454
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Platelet; Week 8; n= 34,36,34,37,29,27	-11.5 Giga cells per liter (GI/L) Standard Deviation 44.80	1.4 Giga cells per liter (GI/L) Standard Deviation 37.70	8.8 Giga cells per liter (GI/L) Standard Deviation 39.83	-6.2 Giga cells per liter (GI/L) Standard Deviation 34.81	-9.1 Giga cells per liter (GI/L) Standard Deviation 51.69	-22.1 Giga cells per liter (GI/L) Standard Deviation 37.57
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Platelet; Week 12; n=36,36,32,34,28,27	-18.9 Giga cells per liter (GI/L) Standard Deviation 38.67	-4.6 Giga cells per liter (GI/L) Standard Deviation 35.71	-6.8 Giga cells per liter (GI/L) Standard Deviation 24.06	-7.5 Giga cells per liter (GI/L) Standard Deviation 37.94	-5.4 Giga cells per liter (GI/L) Standard Deviation 30.15	-23.6 Giga cells per liter (GI/L) Standard Deviation 38.11
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Platelet; Week 14; n=33,33,32,32,31,27	-8.2 Giga cells per liter (GI/L) Standard Deviation 47.60	5.1 Giga cells per liter (GI/L) Standard Deviation 31.34	6.5 Giga cells per liter (GI/L) Standard Deviation 51.77	3.5 Giga cells per liter (GI/L) Standard Deviation 40.84	-9.0 Giga cells per liter (GI/L) Standard Deviation 38.20	-19.9 Giga cells per liter (GI/L) Standard Deviation 44.95
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Platelet; EW; n=3,3,7,3,10,10	11.7 Giga cells per liter (GI/L) Standard Deviation 18.56	8.4 Giga cells per liter (GI/L) Standard Deviation 24.56	11.3 Giga cells per liter (GI/L) Standard Deviation 59.83	-85.0 Giga cells per liter (GI/L) Standard Deviation 11.00	12.7 Giga cells per liter (GI/L) Standard Deviation 56.01	-19.7 Giga cells per liter (GI/L) Standard Deviation 25.77
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Leukocytes; Week 2; n=37,38,38,37,33,31	-0.02 Giga cells per liter (GI/L) Standard Deviation 1.585	-0.05 Giga cells per liter (GI/L) Standard Deviation 1.972	-0.16 Giga cells per liter (GI/L) Standard Deviation 1.624	0.45 Giga cells per liter (GI/L) Standard Deviation 1.749	0.21 Giga cells per liter (GI/L) Standard Deviation 1.085	0.10 Giga cells per liter (GI/L) Standard Deviation 1.668
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Leukocytes; Week 12; n=36,36,32,34,28,27	0.23 Giga cells per liter (GI/L) Standard Deviation 1.248	-0.49 Giga cells per liter (GI/L) Standard Deviation 1.456	0.49 Giga cells per liter (GI/L) Standard Deviation 1.776	0.03 Giga cells per liter (GI/L) Standard Deviation 1.488	0.18 Giga cells per liter (GI/L) Standard Deviation 1.249	-0.05 Giga cells per liter (GI/L) Standard Deviation 1.371
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Basophils; Week 2; n= 37,38,38,37,33,31	-0.002 Giga cells per liter (GI/L) Standard Deviation 0.0175	-0.004 Giga cells per liter (GI/L) Standard Deviation 0.0166	0.000 Giga cells per liter (GI/L) Standard Deviation 0.0176	-0.006 Giga cells per liter (GI/L) Standard Deviation 0.0177	-0.001 Giga cells per liter (GI/L) Standard Deviation 0.0205	-0.000 Giga cells per liter (GI/L) Standard Deviation 0.0201
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Basophils; Week 4; n= 38,38,38,37,30,31	-0.000 Giga cells per liter (GI/L) Standard Deviation 0.0191	-0.006 Giga cells per liter (GI/L) Standard Deviation 0.0192	0.006 Giga cells per liter (GI/L) Standard Deviation 0.0218	-0.002 Giga cells per liter (GI/L) Standard Deviation 0.0195	0.000 Giga cells per liter (GI/L) Standard Deviation 0.0201	0.005 Giga cells per liter (GI/L) Standard Deviation 0.0241
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Basophils; Week 8; n= 34,36,34,37,29,27	-0.007 Giga cells per liter (GI/L) Standard Deviation 0.0161	-0.005 Giga cells per liter (GI/L) Standard Deviation 0.0218	0.004 Giga cells per liter (GI/L) Standard Deviation 0.0162	-0.004 Giga cells per liter (GI/L) Standard Deviation 0.0224	-0.001 Giga cells per liter (GI/L) Standard Deviation 0.0214	0.000 Giga cells per liter (GI/L) Standard Deviation 0.0165
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Basophils; Week 12; n= 36,36,32,34,28,27	0.003 Giga cells per liter (GI/L) Standard Deviation 0.0343	0.003 Giga cells per liter (GI/L) Standard Deviation 0.0348	0.010 Giga cells per liter (GI/L) Standard Deviation 0.0236	0.001 Giga cells per liter (GI/L) Standard Deviation 0.0166	0.002 Giga cells per liter (GI/L) Standard Deviation 0.0191	0.005 Giga cells per liter (GI/L) Standard Deviation 0.0244
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Basophils; Week 14; n= 33,33,32,32,31,27	-0.003 Giga cells per liter (GI/L) Standard Deviation 0.0226	0.008 Giga cells per liter (GI/L) Standard Deviation 0.0312	-0.001 Giga cells per liter (GI/L) Standard Deviation 0.0188	-0.001 Giga cells per liter (GI/L) Standard Deviation 0.0160	-0.000 Giga cells per liter (GI/L) Standard Deviation 0.0190	0.003 Giga cells per liter (GI/L) Standard Deviation 0.0202
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Eosinophils; Week 4; n=38,38,38,37,30,31	-0.034 Giga cells per liter (GI/L) Standard Deviation 0.2143	0.063 Giga cells per liter (GI/L) Standard Deviation 0.4729	0.057 Giga cells per liter (GI/L) Standard Deviation 0.1644	-0.075 Giga cells per liter (GI/L) Standard Deviation 0.3146	-0.049 Giga cells per liter (GI/L) Standard Deviation 0.2401	-0.119 Giga cells per liter (GI/L) Standard Deviation 0.3926
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Eosinophils; Week 8; n=34,36,34,37,29,27	-0.034 Giga cells per liter (GI/L) Standard Deviation 0.2271	0.009 Giga cells per liter (GI/L) Standard Deviation 0.1923	0.106 Giga cells per liter (GI/L) Standard Deviation 0.2805	-0.052 Giga cells per liter (GI/L) Standard Deviation 0.3486	-0.040 Giga cells per liter (GI/L) Standard Deviation 0.1398	-0.107 Giga cells per liter (GI/L) Standard Deviation 0.3276
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Eosinophils; Week 12; n= 36,36,32,34,28,27	-0.063 Giga cells per liter (GI/L) Standard Deviation 0.1751	-0.028 Giga cells per liter (GI/L) Standard Deviation 0.2176	0.033 Giga cells per liter (GI/L) Standard Deviation 0.1606	-0.083 Giga cells per liter (GI/L) Standard Deviation 0.3212	-0.026 Giga cells per liter (GI/L) Standard Deviation 0.1811	-0.120 Giga cells per liter (GI/L) Standard Deviation 0.3025
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Eosinophils; Week 14; n= 33,33,32,32,31,27	-0.056 Giga cells per liter (GI/L) Standard Deviation 0.1493	-0.041 Giga cells per liter (GI/L) Standard Deviation 0.2107	0.038 Giga cells per liter (GI/L) Standard Deviation 0.1779	-0.078 Giga cells per liter (GI/L) Standard Deviation 0.3178	-0.043 Giga cells per liter (GI/L) Standard Deviation 0.2237	-0.104 Giga cells per liter (GI/L) Standard Deviation 0.2377
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Lymphocytes; Week 4; n= 38,38,38,37,30,31	0.021 Giga cells per liter (GI/L) Standard Deviation 0.4099	-0.078 Giga cells per liter (GI/L) Standard Deviation 0.4874	0.151 Giga cells per liter (GI/L) Standard Deviation 0.5349	0.054 Giga cells per liter (GI/L) Standard Deviation 0.5264	0.217 Giga cells per liter (GI/L) Standard Deviation 0.5292	0.083 Giga cells per liter (GI/L) Standard Deviation 0.5894
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Lymphocytes; Week 8; n= 34,36,34,37,29,27	-0.031 Giga cells per liter (GI/L) Standard Deviation 0.3914	-0.018 Giga cells per liter (GI/L) Standard Deviation 0.5285	0.166 Giga cells per liter (GI/L) Standard Deviation 0.4024	0.100 Giga cells per liter (GI/L) Standard Deviation 0.3953	0.165 Giga cells per liter (GI/L) Standard Deviation 0.6213	0.012 Giga cells per liter (GI/L) Standard Deviation 0.4463
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Lymphocytes; Week 12; n= 36,36,32,34,28,27	0.072 Giga cells per liter (GI/L) Standard Deviation 0.4836	-0.034 Giga cells per liter (GI/L) Standard Deviation 0.5779	0.116 Giga cells per liter (GI/L) Standard Deviation 0.3819	0.045 Giga cells per liter (GI/L) Standard Deviation 0.4806	0.232 Giga cells per liter (GI/L) Standard Deviation 0.6258	0.061 Giga cells per liter (GI/L) Standard Deviation 0.5758
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Monocytes; Week 2; n=37,38,38,37,33,31	0.008 Giga cells per liter (GI/L) Standard Deviation 0.0965	-0.028 Giga cells per liter (GI/L) Standard Deviation 0.1415	0.019 Giga cells per liter (GI/L) Standard Deviation 0.1948	-0.028 Giga cells per liter (GI/L) Standard Deviation 0.1465	-0.025 Giga cells per liter (GI/L) Standard Deviation 0.1271	0.013 Giga cells per liter (GI/L) Standard Deviation 0.1659
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Monocytes; Week 4; n= 38,38,38,37,30,31	0.006 Giga cells per liter (GI/L) Standard Deviation 0.1151	-0.047 Giga cells per liter (GI/L) Standard Deviation 0.1611	0.010 Giga cells per liter (GI/L) Standard Deviation 0.1419	-0.004 Giga cells per liter (GI/L) Standard Deviation 0.1769	-0.023 Giga cells per liter (GI/L) Standard Deviation 0.1230	-0.059 Giga cells per liter (GI/L) Standard Deviation 0.1648
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Monocytes; Week 12; n=36,36,32,34,28,27	-0.019 Giga cells per liter (GI/L) Standard Deviation 0.1434	-0.078 Giga cells per liter (GI/L) Standard Deviation 0.1736	0.007 Giga cells per liter (GI/L) Standard Deviation 0.1801	-0.061 Giga cells per liter (GI/L) Standard Deviation 0.1653	-0.022 Giga cells per liter (GI/L) Standard Deviation 0.1219	-0.042 Giga cells per liter (GI/L) Standard Deviation 0.1539
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Monocytes; EW; n=3,3,7,3,10,10	0.040 Giga cells per liter (GI/L) Standard Deviation 0.0608	-0.018 Giga cells per liter (GI/L) Standard Deviation 0.0966	-0.159 Giga cells per liter (GI/L) Standard Deviation 0.1672	-0.127 Giga cells per liter (GI/L) Standard Deviation 0.0924	0.007 Giga cells per liter (GI/L) Standard Deviation 0.0850	0.030 Giga cells per liter (GI/L) Standard Deviation 0.1133
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Neutrophils; Week 2; n=37,38,38,37,33,31	-0.088 Giga cells per liter (GI/L) Standard Deviation 1.4680	-0.097 Giga cells per liter (GI/L) Standard Deviation 1.8249	-0.258 Giga cells per liter (GI/L) Standard Deviation 1.2803	0.480 Giga cells per liter (GI/L) Standard Deviation 1.7953	0.152 Giga cells per liter (GI/L) Standard Deviation 1.0058	0.067 Giga cells per liter (GI/L) Standard Deviation 1.7035
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Neutrophils; Week 12; n= 36,36,32,34,28,27	0.237 Giga cells per liter (GI/L) Standard Deviation 1.1459	-0.348 Giga cells per liter (GI/L) Standard Deviation 1.5514	0.328 Giga cells per liter (GI/L) Standard Deviation 1.6786	0.127 Giga cells per liter (GI/L) Standard Deviation 1.3363	-0.009 Giga cells per liter (GI/L) Standard Deviation 1.1315	0.049 Giga cells per liter (GI/L) Standard Deviation 1.4294
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Neutrophils; Week 14; n=33,33,32,32,31,27	-0.058 Giga cells per liter (GI/L) Standard Deviation 1.5202	-0.155 Giga cells per liter (GI/L) Standard Deviation 1.9840	-0.013 Giga cells per liter (GI/L) Standard Deviation 1.4826	0.090 Giga cells per liter (GI/L) Standard Deviation 1.2037	0.164 Giga cells per liter (GI/L) Standard Deviation 1.2465	-0.368 Giga cells per liter (GI/L) Standard Deviation 1.0224
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Neutrophils; EW; n=3,3,7,3,10,10	0.630 Giga cells per liter (GI/L) Standard Deviation 1.0741	-0.331 Giga cells per liter (GI/L) Standard Deviation 1.2306	0.158 Giga cells per liter (GI/L) Standard Deviation 1.8160	-0.420 Giga cells per liter (GI/L) Standard Deviation 0.9924	0.047 Giga cells per liter (GI/L) Standard Deviation 0.7478	0.797 Giga cells per liter (GI/L) Standard Deviation 2.1506
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Platelet; Week 2; n=37,38,38,37,33,31	-20.2 Giga cells per liter (GI/L) Standard Deviation 30.63	-0.5 Giga cells per liter (GI/L) Standard Deviation 31.18	6.9 Giga cells per liter (GI/L) Standard Deviation 31.60	-15.4 Giga cells per liter (GI/L) Standard Deviation 44.06	-18.7 Giga cells per liter (GI/L) Standard Deviation 36.48	-25.9 Giga cells per liter (GI/L) Standard Deviation 43.03
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count Platelet; Week 4; n=38,38,38,37,30,31	-7.7 Giga cells per liter (GI/L) Standard Deviation 38.40	-2.4 Giga cells per liter (GI/L) Standard Deviation 30.48	12.7 Giga cells per liter (GI/L) Standard Deviation 29.38	-12.4 Giga cells per liter (GI/L) Standard Deviation 36.57	-19.7 Giga cells per liter (GI/L) Standard Deviation 36.44	-25.2 Giga cells per liter (GI/L) Standard Deviation 35.75

SECONDARY outcome

Timeframe: Week 2, 4, 8, 12, 14, EW (up to week 14)

Population: Safety Population

Blood samples were collected to evaluate change from Baseline in hematocrit and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.

Outcome measures

Outcome measures
Measure	GSK2894512 0.5% QD n=41 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=42 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=40 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	GSK2894512 1% BID n=40 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=41 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=43 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
Change From Baseline in Hematocrit Levels Week 2; n= 37,38,38,37,33,31	-0.0116 Proportion of red blood cells in blood Standard Deviation 0.0246	-0.0014 Proportion of red blood cells in blood Standard Deviation 0.0267	-0.0095 Proportion of red blood cells in blood Standard Deviation 0.0239	-0.0054 Proportion of red blood cells in blood Standard Deviation 0.0276	-0.0132 Proportion of red blood cells in blood Standard Deviation 0.0195	-0.0138 Proportion of red blood cells in blood Standard Deviation 0.0260
Change From Baseline in Hematocrit Levels Week 8; n=34,36,34,37,29,27	-0.0042 Proportion of red blood cells in blood Standard Deviation 0.0235	-0.0011 Proportion of red blood cells in blood Standard Deviation 0.0264	-0.0124 Proportion of red blood cells in blood Standard Deviation 0.0314	-0.0066 Proportion of red blood cells in blood Standard Deviation 0.0316	-0.0148 Proportion of red blood cells in blood Standard Deviation 0.0225	-0.0091 Proportion of red blood cells in blood Standard Deviation 0.0225
Change From Baseline in Hematocrit Levels Week 12; n= 36,36,32,34,28,27	-0.0106 Proportion of red blood cells in blood Standard Deviation 0.0227	-0.0052 Proportion of red blood cells in blood Standard Deviation 0.0312	-0.0111 Proportion of red blood cells in blood Standard Deviation 0.0240	-0.0054 Proportion of red blood cells in blood Standard Deviation 0.0302	-0.0129 Proportion of red blood cells in blood Standard Deviation 0.0222	-0.0131 Proportion of red blood cells in blood Standard Deviation 0.0205
Change From Baseline in Hematocrit Levels Week 14; n= 33,33,32,32,31,28	-0.0063 Proportion of red blood cells in blood Standard Deviation 0.0286	-0.0007 Proportion of red blood cells in blood Standard Deviation 0.0277	-0.0117 Proportion of red blood cells in blood Standard Deviation 0.0292	-0.0151 Proportion of red blood cells in blood Standard Deviation 0.0292	-0.0170 Proportion of red blood cells in blood Standard Deviation 0.0236	-0.0132 Proportion of red blood cells in blood Standard Deviation 0.0193
Change From Baseline in Hematocrit Levels EW; n= 3,3,7,3,10,10	-0.0117 Proportion of red blood cells in blood Standard Deviation 0.0133	0.0027 Proportion of red blood cells in blood Standard Deviation 0.0152	0.0048 Proportion of red blood cells in blood Standard Deviation 0.0248	0.0037 Proportion of red blood cells in blood Standard Deviation 0.0123	-0.0063 Proportion of red blood cells in blood Standard Deviation 0.0352	-0.0174 Proportion of red blood cells in blood Standard Deviation 0.0292
Change From Baseline in Hematocrit Levels Week 4; n= 38,38,38,37,30,31	-0.0075 Proportion of red blood cells in blood Standard Deviation 0.0233	-0.0090 Proportion of red blood cells in blood Standard Deviation 0.0283	-0.0123 Proportion of red blood cells in blood Standard Deviation 0.0295	-0.0107 Proportion of red blood cells in blood Standard Deviation 0.0315	-0.0075 Proportion of red blood cells in blood Standard Deviation 0.0241	-0.0081 Proportion of red blood cells in blood Standard Deviation 0.0253

SECONDARY outcome

Timeframe: Week 2, 4, 8, 12, 14, EW (up to week 14)

Population: Safety Population

Blood samples were collected to evaluate change from Baseline in hemoglobin and MCHC and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.

Outcome measures

Outcome measures
Measure	GSK2894512 0.5% QD n=41 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=42 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=40 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	GSK2894512 1% BID n=40 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=41 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=43 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Hemoglobin; Week 2; n= 37,38,38,37,33,31	-2.8 G/L Standard Deviation 6.78	-0.9 G/L Standard Deviation 8.76	-3.0 G/L Standard Deviation 6.55	-1.8 G/L Standard Deviation 9.02	-3.8 G/L Standard Deviation 5.54	-4.3 G/L Standard Deviation 8.08
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Hemoglobin; Week 4; n= 38,38,38,37,30,31	-2.4 G/L Standard Deviation 6.27	-3.0 G/L Standard Deviation 9.17	-4.1 G/L Standard Deviation 9.05	-3.2 G/L Standard Deviation 8.88	-2.7 G/L Standard Deviation 6.42	-3.5 G/L Standard Deviation 7.72
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Hemoglobin; EW; n= 3,3,7,3,10,10	-2.0 G/L Standard Deviation 9.00	0.0 G/L Standard Deviation 3.77	-1.1 G/L Standard Deviation 5.69	0.7 G/L Standard Deviation 11.59	-1.3 G/L Standard Deviation 11.59	-6.0 G/L Standard Deviation 8.47
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) MCHC; Week 8; n=34,36,34,37,29,27	-0.5 G/L Standard Deviation 11.02	-0.5 G/L Standard Deviation 10.28	-1.3 G/L Standard Deviation 8.96	-1.1 G/L Standard Deviation 9.28	0.4 G/L Standard Deviation 11.61	-1.9 G/L Standard Deviation 8.69
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) MCHC; Week 12; n= 36,36,32,34,28,27	0.9 G/L Standard Deviation 10.85	-1.4 G/L Standard Deviation 10.77	-1.8 G/L Standard Deviation 9.95	-1.0 G/L Standard Deviation 10.23	0.1 G/L Standard Deviation 11.12	-2.5 G/L Standard Deviation 10.95
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Hemoglobin; Week 8; n=34,36,34,37,29,27	-1.6 G/L Standard Deviation 6.70	-0.8 G/L Standard Deviation 7.59	-4.6 G/L Standard Deviation 9.72	-2.7 G/L Standard Deviation 9.64	-4.6 G/L Standard Deviation 6.43	-3.7 G/L Standard Deviation 6.90
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) MCHC; Week 2; n= 37,38,38,37,33,31	2.0 G/L Standard Deviation 10.23	-1.4 G/L Standard Deviation 8.37	8.37 G/L Standard Deviation 8.92	0.1 G/L Standard Deviation 7.47	0.9 G/L Standard Deviation 7.83	0.8 G/L Standard Deviation 6.65
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) MCHC; Week 4; n= 38,38,38,37,30,31	0.2 G/L Standard Deviation 9.62	0.0 G/L Standard Deviation 9.14	0.1 G/L Standard Deviation 8.17	0.9 G/L Standard Deviation 8.89	-0.3 G/L Standard Deviation 9.51	-1.9 G/L Standard Deviation 9.53
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) MCHC; Week 14; n= 33,33,32,32,31,28	0.7 G/L Standard Deviation 10.42	-1.0 G/L Standard Deviation 11.18	-0.1 G/L Standard Deviation 8.59	-1.2 G/L Standard Deviation 11.15	3.9 G/L Standard Deviation 10.96	-2.2 G/L Standard Deviation 10.24
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) MCHC; EW; n= 3,3,7,3,10,10	3.3 G/L Standard Deviation 12.86	-2.2 G/L Standard Deviation 5.25	-6.6 G/L Standard Deviation 9.09	-1.7 G/L Standard Deviation 20.26	1.7 G/L Standard Deviation 2.52	-1.1 G/L Standard Deviation 10.64
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Hemoglobin; Week 12; n= 36,36,32,34,28,27	-3.1 G/L Standard Deviation 5.58	-2.5 G/L Standard Deviation 9.52	-4.4 G/L Standard Deviation 6.63	-2.3 G/L Standard Deviation 9.33	-4.2 G/L Standard Deviation 6.61	-5.2 G/L Standard Deviation 6.77
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Hemoglobin; Week 14; n= 33,33,32,32,31,28	-1.8 G/L Standard Deviation 8.17	-0.8 G/L Standard Deviation 8.51	-4.0 G/L Standard Deviation 7.93	-5.5 G/L Standard Deviation 9.25	-3.9 G/L Standard Deviation 6.76	-5.2 G/L Standard Deviation 6.73

SECONDARY outcome

Timeframe: Week 2, 4, 8, 12, 14, EW (up to week 14)

Population: Safety Population

Blood samples were collected to evaluate change from Baseline in MCH and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.

Outcome measures

Outcome measures
Measure	GSK2894512 0.5% QD n=41 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=42 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=40 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	GSK2894512 1% BID n=40 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=41 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=43 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Week 2; n= 37,38,38,37,33,31	0.19 Picogram (Pg) Standard Deviation 0.667	0.04 Picogram (Pg) Standard Deviation 0.415	0.05 Picogram (Pg) Standard Deviation 0.490	0.05 Picogram (Pg) Standard Deviation 0.425	0.09 Picogram (Pg) Standard Deviation 0.595	0.06 Picogram (Pg) Standard Deviation 0.408
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Week 4; n= 38,38,38,37,30,31	0.15 Picogram (Pg) Standard Deviation 0.567	0.06 Picogram (Pg) Standard Deviation 0.518	-0.05 Picogram (Pg) Standard Deviation 0.528	0.09 Picogram (Pg) Standard Deviation 0.535	0.06 Picogram (Pg) Standard Deviation 0.593	-0.01 Picogram (Pg) Standard Deviation 0.519
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Week 8; n=34,36,34,37,29,27	0.22 Picogram (Pg) Standard Deviation 0.781	0.02 Picogram (Pg) Standard Deviation 0.599	-0.07 Picogram (Pg) Standard Deviation 0.640	0.03 Picogram (Pg) Standard Deviation 0.635	0.21 Picogram (Pg) Standard Deviation 0.747	-0.06 Picogram (Pg) Standard Deviation 0.536
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Week 12; n= 36,36,32,34,28,27	0.30 Picogram (Pg) Standard Deviation 0.815	0.04 Picogram (Pg) Standard Deviation 0.588	0.06 Picogram (Pg) Standard Deviation 0.806	0.14 Picogram (Pg) Standard Deviation 0.708	0.14 Picogram (Pg) Standard Deviation 0.790	0.10 Picogram (Pg) Standard Deviation 0.506
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Week 14; n= 33,33,32,32,31,28	0.28 Picogram (Pg) Standard Deviation 0.612	0.06 Picogram (Pg) Standard Deviation 0.804	-0.01 Picogram (Pg) Standard Deviation 0.589	0.06 Picogram (Pg) Standard Deviation 0.900	0.55 Picogram (Pg) Standard Deviation 0.806	0.08 Picogram (Pg) Standard Deviation 0.449
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) EW; n= 3,3,7,3,10,10	0.63 Picogram (Pg) Standard Deviation 0.808	-0.13 Picogram (Pg) Standard Deviation 0.933	-0.15 Picogram (Pg) Standard Deviation 0.542	0.57 Picogram (Pg) Standard Deviation 1.361	0.03 Picogram (Pg) Standard Deviation 0.702	-0.19 Picogram (Pg) Standard Deviation 0.596

SECONDARY outcome

Timeframe: Week 2, 4, 8, 12, 14, EW (up to week 14)

Population: Safety Population

Blood samples were collected to evaluate change from Baseline in MCV and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.

Outcome measures

Outcome measures
Measure	GSK2894512 0.5% QD n=41 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=42 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=40 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	GSK2894512 1% BID n=40 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=41 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=43 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
Change From Baseline in Mean Corpuscle Volume (MCV) Week 2; n= 37,38,38,37,33,31	-0.1 Femtoliter (fL) Standard Deviation 2.37	0.5 Femtoliter (fL) Standard Deviation 1.87	0.1 Femtoliter (fL) Standard Deviation 1.83	0.2 Femtoliter (fL) Standard Deviation 2.02	-0.2 Femtoliter (fL) Standard Deviation 1.45	-0.1 Femtoliter (fL) Standard Deviation 1.47
Change From Baseline in Mean Corpuscle Volume (MCV) Week 4; n= 38,38,38,37,30,31	0.4 Femtoliter (fL) Standard Deviation 2.80	0.1 Femtoliter (fL) Standard Deviation 1.90	-0.3 Femtoliter (fL) Standard Deviation 1.85	0.1 Femtoliter (fL) Standard Deviation 1.75	0.2 Femtoliter (fL) Standard Deviation 2.04	0.5 Femtoliter (fL) Standard Deviation 1.94
Change From Baseline in Mean Corpuscle Volume (MCV) Week 8; n=34,36,34,37,29,27	0.7 Femtoliter (fL) Standard Deviation 2.90	0.2 Femtoliter (fL) Standard Deviation 2.39	0.0 Femtoliter (fL) Standard Deviation 2.01	0.5 Femtoliter (fL) Standard Deviation 2.42	0.5 Femtoliter (fL) Standard Deviation 2.52	0.4 Femtoliter (fL) Standard Deviation 1.78
Change From Baseline in Mean Corpuscle Volume (MCV) Week 12; n= 36,36,32,34,28,27	0.6 Femtoliter (fL) Standard Deviation 3.20	0.5 Femtoliter (fL) Standard Deviation 3.06	0.5 Femtoliter (fL) Standard Deviation 1.99	0.8 Femtoliter (fL) Standard Deviation 2.80	0.3 Femtoliter (fL) Standard Deviation 2.68	1.0 Femtoliter (fL) Standard Deviation 2.62
Change From Baseline in Mean Corpuscle Volume (MCV) Week 14; n= 33,33,32,32,31,28	0.7 Femtoliter (fL) Standard Deviation 2.37	0.4 Femtoliter (fL) Standard Deviation 3.19	-0.1 Femtoliter (fL) Standard Deviation 2.25	0.6 Femtoliter (fL) Standard Deviation 2.92	0.4 Femtoliter (fL) Standard Deviation 2.54	0.9 Femtoliter (fL) Standard Deviation 2.54
Change From Baseline in Mean Corpuscle Volume (MCV) EW; n= 3,3,7,3,10,10	1.0 Femtoliter (fL) Standard Deviation 1.00	-0.1 Femtoliter (fL) Standard Deviation 2.81	1.4 Femtoliter (fL) Standard Deviation 2.59	1.7 Femtoliter (fL) Standard Deviation 1.53	-0.7 Femtoliter (fL) Standard Deviation 2.08	-0.4 Femtoliter (fL) Standard Deviation 2.15

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 14, EW (week up to 14)

Population: Safety Population

Blood samples were collected to evaluate change from Baseline in erythrocytes and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.

Outcome measures

Outcome measures
Measure	GSK2894512 0.5% QD n=41 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=42 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=40 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	GSK2894512 1% BID n=40 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=41 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=43 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
Change From Baseline in Erythrocyte Count Week 2; n= 37,38,38,37,33,31	-0.12 Tetra cells per liter (TI/L) Standard Deviation 0.260	-0.03 Tetra cells per liter (TI/L) Standard Deviation 0.293	-0.12 Tetra cells per liter (TI/L) Standard Deviation 0.241	-0.06 Tetra cells per liter (TI/L) Standard Deviation 0.325	-0.16 Tetra cells per liter (TI/L) Standard Deviation 0.218	-0.15 Tetra cells per liter (TI/L) Standard Deviation 0.287
Change From Baseline in Erythrocyte Count Week 8; n=34,36,34,37,29,27	-0.08 Tetra cells per liter (TI/L) Standard Deviation 0.205	-0.03 Tetra cells per liter (TI/L) Standard Deviation 0.268	-0.14 Tetra cells per liter (TI/L) Standard Deviation 0.318	-0.10 Tetra cells per liter (TI/L) Standard Deviation 0.371	-0.21 Tetra cells per liter (TI/L) Standard Deviation 0.227	-0.12 Tetra cells per liter (TI/L) Standard Deviation 0.265
Change From Baseline in Erythrocyte Count Week 12; n= 36,36,32,34,28,27	-0.15 Tetra cells per liter (TI/L) Standard Deviation 0.191	-0.09 Tetra cells per liter (TI/L) Standard Deviation 0.314	-0.15 Tetra cells per liter (TI/L) Standard Deviation 0.262	-0.09 Tetra cells per liter (TI/L) Standard Deviation 0.345	-0.18 Tetra cells per liter (TI/L) Standard Deviation 0.244	-0.21 Tetra cells per liter (TI/L) Standard Deviation 0.250
Change From Baseline in Erythrocyte Count EW; n= 3,3,7,3,10,10	-0.13 Tetra cells per liter (TI/L) Standard Deviation 0.153	0.04 Tetra cells per liter (TI/L) Standard Deviation 0.246	-0.03 Tetra cells per liter (TI/L) Standard Deviation 0.267	-0.03 Tetra cells per liter (TI/L) Standard Deviation 0.252	-0.07 Tetra cells per liter (TI/L) Standard Deviation 0.321	-0.19 Tetra cells per liter (TI/L) Standard Deviation 0.297
Change From Baseline in Erythrocyte Count Week 4; n= 38,38,38,37,30,31	-0.10 Tetra cells per liter (TI/L) Standard Deviation 0.215	-0.11 Tetra cells per liter (TI/L) Standard Deviation 0.317	-0.13 Tetra cells per liter (TI/L) Standard Deviation 0.312	-0.12 Tetra cells per liter (TI/L) Standard Deviation 0.347	-0.10 Tetra cells per liter (TI/L) Standard Deviation 0.256	-0.13 Tetra cells per liter (TI/L) Standard Deviation 0.273
Change From Baseline in Erythrocyte Count Week 14; n= 33,33,32,32,31,28	-0.10 Tetra cells per liter (TI/L) Standard Deviation 0.261	-0.03 Tetra cells per liter (TI/L) Standard Deviation 0.330	-0.14 Tetra cells per liter (TI/L) Standard Deviation 0.312	-0.20 Tetra cells per liter (TI/L) Standard Deviation 0.342	-0.22 Tetra cells per liter (TI/L) Standard Deviation 0.262	-0.21 Tetra cells per liter (TI/L) Standard Deviation 0.229

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12, 14, early withdrawal, and post screen (up to Week 16)

Population: Safety Population

Blood samples were collected from participants for evaluation of hematology parameters by Potential Clinical Importance Criteria from Baseline to Week 14, EW and any visit post-screen. The vital signs included hematocrit, hemoglobin, lymphocytes, neutrophils, platelet and leukocytes. Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	GSK2894512 0.5% QD n=41 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=42 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=40 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	GSK2894512 1% BID n=40 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=41 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=43 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
Number of Participants With Hematology Data of Potential Clinical Importance Platelets; Week 8; n= 34,36,34,38,29,28	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Hematocrit; Baseline; n= 40, 40, 43, 40, 42, 39	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Hematocrit; Week 2; n= 37, 39, 38, 38, 33, 31	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Hematocrit; Week 14; n= 33,34,32,33,31,29	0 Participants	0 Participants	2 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Lymphocytes;Baseline; n= 40, 40, 43, 40, 42, 39	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Lymphocytes; Week 8; n= 34,36,34,38,29,28	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Leukocytes; Week 12; n= 36, 37, 32, 35, 28,28	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Leukocytes; n= EW; n=3,3,7,3,10,10	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Lymphocytes; post-screen; n= 40,40,40,39,39,40	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Platelets; post-screen; n= 40,40,40,39,39,40	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Neutrophils; Week 12; n= 36, 37, 32, 35, 28,28	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Neutrophils; Week 14; n=33,34,32,33,31,29	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Neutrophils; post-screen;n= 40,40,40,39,39,40	1 Participants	0 Participants	0 Participants	4 Participants	2 Participants	1 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Neutrophils; EW; n=3,3,7,3,10,10	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Platelets; Baseline; n= 40, 40, 43, 40, 42, 39	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Platelets; Week 2; n= :37,38,38,38,33,31	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Platelets; Week 4; n=37,39, 38,38,30,32	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Platelets; Week 12; n= 35,37,32,35,28,28	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Platelets; Week 14; n=33,34,32,33,31,29	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Platelets; EW; n=3,3,7,3,10,10	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Leukocytes; Baseline; n= 40, 40, 43, 40, 42, 39	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Leukocytes; Week 2; n=37, 39, 38, 38, 33, 31	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Leukocytes; Week 4; n=38, 39, 38,38,30,32	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Leukocytes; Week 8; n=34,36,34,38,29,28	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Hemoglobin; EW; n= 3,3,7,3,10,10	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Hemoglobin; post-screen; n= 40,40,40,39,39,40	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Neutrophils; Baseline; n= 40, 40, 43, 40, 42, 39	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Hematocrit; Week 4; n= 38, 39, 38,38,30,32	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Hematocrit; Week 8; n=34,36,34,38,29,28	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Hematocrit; Week 12; n= 36, 37, 32, 35, 28,28	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Hematocrit; EW; n= 3,3,7,3,10,10	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Hematocrit; post-screen; n= 40,40,40,39,39,40	0 Participants	1 Participants	2 Participants	2 Participants	0 Participants	1 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Hemoglobin; Baseline;n= 40, 40, 43, 40, 42, 39	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Hemoglobin; Week 2; n= 37, 39, 38, 38, 33, 31	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Hemoglobin; Week 4; n= 38, 39, 38,38,30,32	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Hemoglobin; Week 8; n= 34,36,34,38,29,28	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Hemoglobin; Week 12; n= 36, 37, 32, 35, 28,28	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Hemoglobin; Week 14; n=33,34,32,33,31,29	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Lymphocytes; Week 2; n= 37, 39, 38, 38, 33, 31	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Lymhocytes; Week 4; n= 38, 39, 38,38,30,32	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Lymphocytes; EW;n= 3,3,7,3,10,10	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Lymphocytes; Week 12; n=36, 37, 32, 35, 28,28	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Lymphocytes; Week 14; n= 33,34,32,33,31,28	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Leukocytes; Week 14; n=33,34,32,33,31,28	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Leukocytes; post-screen; n= 40,40,40,39,39,40	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Neutrophils; Week 2; n= 37, 39, 38, 38, 33, 31	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Neutrophils; Week 4; n= 38, 39, 38,38,30,32	0 Participants	0 Participants	0 Participants	4 Participants	0 Participants	1 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Neutrophils; Week 8; n= 34,36,34,38,29,28	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Week, 4, 8 and 12

Population: Safety population

Blood samples were collected to evaluate change from Baseline in total T lympho, B lympho, T and B NK cells and (Foxp3) values at Baseline throughout the 12 weeks of study treatment. The immunophenotyping parameters included cluster of differentiation (CD)19, CD3, CD3+CD8+, CD3+CD4+, CD16+CD56+, CD3+CD4+CD25+CD127, CD3+CD4+foxP3+CD25+CD127 and T and NK lympho. CD3, CD3+CD8+ and CD3+CD4+ were also evaluated by using treg flow cytometry (cyto). Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.

Outcome measures

Outcome measures
Measure	GSK2894512 0.5% QD n=41 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=42 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=40 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	GSK2894512 1% BID n=40 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=41 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=43 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels CD3+CD8+; Week 12;n=35,37,32,34,27,27	-0.0115 GI/L Standard Deviation 0.0868	-0.0853 GI/L Standard Deviation 0.1818	-0.0023 GI/L Standard Deviation 0.1097	-0.0307 GI/L Standard Deviation 0.1754	0.0270 GI/L Standard Deviation 0.1392	0.0357 GI/L Standard Deviation 0.1578
Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels CD3+CD4+ treg flow cyto;Week 4;n=35,37,36,35,28,28	0.0135 GI/L Standard Deviation 0.2167	-0.0229 GI/L Standard Deviation 0.2878	0.1215 GI/L Standard Deviation 0.2442	0.0117 GI/L Standard Deviation 0.2048	0.0575 GI/L Standard Deviation 0.2571	0.0825 GI/L Standard Deviation 0.1875
Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels CD3+CD4+treg flow cyto;Week 12;n=32,36,31,32,25,24	0.0141 GI/L Standard Deviation 0.1885	-0.0403 GI/L Standard Deviation 0.3331	0.0213 GI/L Standard Deviation 0.1940	0.0235 GI/L Standard Deviation 0.2508	0.1058 GI/L Standard Deviation 0.2718	0.0979 GI/L Standard Deviation 0.2691
Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels CD16+CD56+; Week 8; n=34,37,34,37,28,27	-0.009 GI/L Standard Deviation 0.0919	-0.029 GI/L Standard Deviation 0.0860	-0.012 GI/L Standard Deviation 0.1131	-0.013 GI/L Standard Deviation 0.0909	-0.012 GI/L Standard Deviation 0.1594	-0.016 GI/L Standard Deviation 0.1045
Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels CD3+CD4+CD25+CD127; Week4;n=35,37,36,35,28,28	0.0005 GI/L Standard Deviation 0.0174	-0.0050 GI/L Standard Deviation 0.0179	0.0098 GI/L Standard Deviation 0.0345	0.0006 GI/L Standard Deviation 0.0139	0.0023 GI/L Standard Deviation 0.0150	0.0022 GI/L Standard Deviation 0.0172
Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels CD3+CD4+CD25+CD127; Week8;n=31,35,32,36,27,25	0.0029 GI/L Standard Deviation 0.0196	-0.0049 GI/L Standard Deviation 0.0181	0.0054 GI/L Standard Deviation 0.0222	0.0044 GI/L Standard Deviation 0.0199	0.0062 GI/L Standard Deviation 0.0167	0.0026 GI/L Standard Deviation 0.0223
Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels CD3+CD4+CD25+CD127; Week12;n=32,36,31,32,25,24	0.0054 GI/L Standard Deviation 0.0217	0.0007 GI/L Standard Deviation 0.0230	0.0055 GI/L Standard Deviation 0.0215	0.0050 GI/L Standard Deviation 0.0193	0.0056 GI/L Standard Deviation 0.0228	0.0081 GI/L Standard Deviation 0.0229
Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels CD3+CD4+foxP3+CD25+CD127;Week4;n=35,37,36,35,28,28	-0.0013 GI/L Standard Deviation 0.0164	0.0008 GI/L Standard Deviation 0.0099	0.0056 GI/L Standard Deviation 0.0123	0.0009 GI/L Standard Deviation 0.0125	0.0001 GI/L Standard Deviation 0.0162	0.0009 GI/L Standard Deviation 0.0129
Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels CD3+CD4+foxP3+CD25+CD127;Week8;n=31,35,32,35,27,25	-0.0015 GI/L Standard Deviation 0.0151	0.0032 GI/L Standard Deviation 0.0151	0.0047 GI/L Standard Deviation 0.0166	0.0070 GI/L Standard Deviation 0.0184	0.0011 GI/L Standard Deviation 0.0147	0.0021 GI/L Standard Deviation 0.0182
Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels CD3+CD4+foxP3+CD25+CD127Week12;n=32,36,31,32,25,24	-0.0012 GI/L Standard Deviation 0.0180	0.0039 GI/L Standard Deviation 0.0160	0.0059 GI/L Standard Deviation 0.0127	0.0076 GI/L Standard Deviation 0.0149	0.0003 GI/L Standard Deviation 0.0198	0.0052 GI/L Standard Deviation 0.0192
Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels T &B cell NK lympho; Week4;n=37,38,38,37,29,32	0.021 GI/L Standard Deviation 0.4664	-0.082 GI/L Standard Deviation 0.6206	0.228 GI/L Standard Deviation 0.5116	0.009 GI/L Standard Deviation 0.5461	0.101 GI/L Standard Deviation 0.5287	0.092 GI/L Standard Deviation 0.5122
Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels T &B cell NK lympho; Week12;n=35,37,32,34,27,27	-0.009 GI/L Standard Deviation 0.4041	-0.236 GI/L Standard Deviation 0.6830	-0.001 GI/L Standard Deviation 0.3842	-0.041 GI/L Standard Deviation 0.5922	0.174 GI/L Standard Deviation 0.5825	0.140 GI/L Standard Deviation 0.5609
Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels CD3+CD8+; Week 4; n= 37,38,38,37,29,32	0.0147 GI/L Standard Deviation 0.1194	-0.0155 GI/L Standard Deviation 0.1608	0.0526 GI/L Standard Deviation 0.1388	-0.0272 GI/L Standard Deviation 0.2077	0.0248 GI/L Standard Deviation 0.1298	0.0282 GI/L Standard Deviation 0.1266
Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels CD19; Week 4; n= 37,38,38,37,29,32	0.0174 GI/L Standard Deviation 0.0933	-0.0217 GI/L Standard Deviation 0.1410	0.0406 GI/L Standard Deviation 0.1114	0.0394 GI/L Standard Deviation 0.1149	0.0407 GI/L Standard Deviation 0.1229	0.0068 GI/L Standard Deviation 0.1532
Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels CD19; Week 8; n=34,37,34,37,28,27	-0.0006 GI/L Standard Deviation 0.1099	-0.0282 GI/L Standard Deviation 0.1502	0.0367 GI/L Standard Deviation 0.0966	0.0273 GI/L Standard Deviation 0.0951	0.0343 GI/L Standard Deviation 0.1480	0.0122 GI/L Standard Deviation 0.1154
Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels CD19; Week 12; n= 35,37,32,34,27,27	0.0224 GI/L Standard Deviation 0.0927	-0.0439 GI/L Standard Deviation 0.1350	0.0041 GI/L Standard Deviation 0.1009	0.0111 GI/L Standard Deviation 0.1262	0.0647 GI/L Standard Deviation 0.1440	0.0317 GI/L Standard Deviation 0.1077
Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels CD3; Week 4; n= 37,38,38,37,29,32	0.0108 GI/L Standard Deviation 0.3364	-0.0397 GI/L Standard Deviation 0.4505	0.1678 GI/L Standard Deviation 0.3583	-0.0050 GI/L Standard Deviation 0.3830	0.0867 GI/L Standard Deviation 0.3809	0.0842 GI/L Standard Deviation 0.3343
Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels CD3; Week 8; n=34,37,34,37,28,27	-0.0593 GI/L Standard Deviation 0.3172	-0.0350 GI/L Standard Deviation 0.4403	0.1066 GI/L Standard Deviation 0.3531	0.0523 GI/L Standard Deviation 0.3117	0.0581 GI/L Standard Deviation 0.4496	0.0334 GI/L Standard Deviation 0.3855
Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels CD3; Week 12; n= 35,37,32,34,27,27	0.0071 GI/L Standard Deviation 0.2729	-0.1338 GI/L Standard Deviation 0.5023	0.0167 GI/L Standard Deviation 0.2879	-0.0045 GI/L Standard Deviation 0.4254	0.1312 GI/L Standard Deviation 0.4033	0.1375 GI/L Standard Deviation 0.4003
Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels CD3 treg flow cyto; Week 4; n= 35,37,36,35,28,28	0.0270 GI/L Standard Deviation 0.3320	-0.0688 GI/L Standard Deviation 0.4764	0.1943 GI/L Standard Deviation 0.3722	-0.0277 GI/L Standard Deviation 0.3912	0.0643 GI/L Standard Deviation 0.3988	0.0682 GI/L Standard Deviation 0.2853
Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels CD3; treg flow cyto; Week 8; n=31,35,32,36,27,25	-0.0647 GI/L Standard Deviation 0.3128	-0.0626 GI/L Standard Deviation 0.4679	0.1302 GI/L Standard Deviation 0.3505	0.0184 GI/L Standard Deviation 0.2929	0.0745 GI/L Standard Deviation 0.4592	-0.0023 GI/L Standard Deviation 0.3513
Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels CD3; treg flow cyto; Week 12; n= 32,36,31,32,25,24	-0.0063 GI/L Standard Deviation 0.2771	-0.1402 GI/L Standard Deviation 0.5450	0.0028 GI/L Standard Deviation 0.3101	-0.0215 GI/L Standard Deviation 0.4120	0.1418 GI/L Standard Deviation 0.4318	0.1171 GI/L Standard Deviation 0.4070
Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels CD3+CD8+; Week 8; n= 34,37,34,37,28,27	-0.0263 GI/L Standard Deviation 0.1145	-0.0315 GI/L Standard Deviation 0.1677	0.0322 GI/L Standard Deviation 0.1721	-0.0048 GI/L Standard Deviation 0.1337	0.0011 GI/L Standard Deviation 0.1561	0.0242 GI/L Standard Deviation 0.1335
Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels CD3+CD8+ treg flow cyto;Week 4;n=35,37,36,35,28,28	0.0038 GI/L Standard Deviation 0.1112	-0.0246 GI/L Standard Deviation 0.1572	0.0728 GI/L Standard Deviation 0.1175	-0.0392 GI/L Standard Deviation 0.2124	0.0211 GI/L Standard Deviation 0.1222	0.0004 GI/L Standard Deviation 0.1117
Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels CD3+CD8+ treg flow cyto;Week 8;n=31,35,32,36,27,25	-0.0376 GI/L Standard Deviation 0.1150	-0.0351 GI/L Standard Deviation 0.1672	0.0484 GI/L Standard Deviation 0.1417	0.0004 GI/L Standard Deviation 0.1228	0.0125 GI/L Standard Deviation 0.1350	-0.0008 GI/L Standard Deviation 0.1214
Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels CD3+CD8+treg flow cyto;Week12;n=32,36,31,32,25,24	-0.0230 GI/L Standard Deviation 0.0865	-0.0689 GI/L Standard Deviation 0.1752	0.0120 GI/L Standard Deviation 0.1064	-0.0179 GI/L Standard Deviation 0.1738	0.0311 GI/L Standard Deviation 0.1338	0.0151 GI/L Standard Deviation 0.1490
Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels CD3+CD4+; Week 4; n= 37,38,38,37,29,32	-0.0030 GI/L Standard Deviation 0.2342	-0.0268 GI/L Standard Deviation 0.2913	0.1138 GI/L Standard Deviation 0.2308	0.0080 GI/L Standard Deviation 0.2066	0.0579 GI/L Standard Deviation 0.2532	0.0562 GI/L Standard Deviation 0.2652
Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels CD3+CD4+; Week 8; n=34,37,34,37,28,27	-0.0287 GI/L Standard Deviation 0.2054	-0.0015 GI/L Standard Deviation 0.2803	0.0778 GI/L Standard Deviation 0.1826	0.0282 GI/L Standard Deviation 0.1739	0.0539 GI/L Standard Deviation 0.2996	0.0072 GI/L Standard Deviation 0.2794
Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels CD3+CD4+; Week 12; n= 35,37,32,34,27,27	0.0216 GI/L Standard Deviation 0.1929	-0.0465 GI/L Standard Deviation 0.3338	0.0181 GI/L Standard Deviation 0.1872	0.0243 GI/L Standard Deviation 0.2551	0.0957 GI/L Standard Deviation 0.2713	0.1087 GI/L Standard Deviation 0.2795
Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels CD3+CD4+ treg flow cyto;Week 8;n=31,35,32,36,27,25	-0.0284 GI/L Standard Deviation 0.2018	-0.0007 GI/L Standard Deviation 0.2751	0.0849 GI/L Standard Deviation 0.1883	0.0286 GI/L Standard Deviation 0.1744	0.0687 GI/L Standard Deviation 0.2923	-0.0158 GI/L Standard Deviation 0.2536
Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels CD16+CD56+; Week 4; n=37,38,38,37,29,32	-0.004 GI/L Standard Deviation 0.1057	-0.009 GI/L Standard Deviation 0.0837	0.016 GI/L Standard Deviation 0.0999	-0.021 GI/L Standard Deviation 0.0942	-0.018 GI/L Standard Deviation 0.0752	-0.019 GI/L Standard Deviation 0.0976
Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels CD16+CD56+; Week 12; n= 35,37,32,34,27,27	-0.036 GI/L Standard Deviation 0.0702	-0.039 GI/L Standard Deviation 0.0909	-0.020 GI/L Standard Deviation 0.0888	-0.038 GI/L Standard Deviation 0.0884	-0.021 GI/L Standard Deviation 0.0911	-0.022 GI/L Standard Deviation 0.0792
Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels T &B cell NK lympho;Week8;n=34,37,34,37,28,27	-0.070 GI/L Standard Deviation 0.4141	-0.109 GI/L Standard Deviation 0.6219	0.132 GI/L Standard Deviation 0.5150	0.059 GI/L Standard Deviation 0.4430	0.083 GI/L Standard Deviation 0.6737	0.025 GI/L Standard Deviation 0.5688

SECONDARY outcome

Timeframe: Baseline, Week, 4, 8, 12 and post-screen (up to Week 16)

Population: Safety population

Blood samples were collected from participants for evaluation of immunophenotyping parameters by Potential Clinical Importance Criteria at Baseline, Week 4, Week 8, Week 12 nd any visit post-screen. The immunophenotyping parameters included CD 19, CD3, CD3+CD8+, CD3+CD4+, CD16+CD56+, CD3+CD4+CD25+CD127, CD3+CD4+foxP3+CD25+CD127 and T and NK lympho. CD3, CD3+CD8+ and CD3+CD4+ were also evaluated by using treg flow cyto. Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	GSK2894512 0.5% QD n=41 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=42 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=40 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	GSK2894512 1% BID n=40 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=41 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=43 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
Number of Participants With Immunopheotyping Data Outside the Reference Range CD19; Baseline; n=40,41,43,40,41,40	2 Participants	1 Participants	2 Participants	0 Participants	0 Participants	5 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD19; Week 4; n= 37,38,38,38,30,32	4 Participants	1 Participants	2 Participants	3 Participants	0 Participants	5 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD19; Week 8; n= 34,37,34,38,29,27	4 Participants	3 Participants	2 Participants	2 Participants	1 Participants	3 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD19; post-screen; n= 38,39,38,39,30,32	7 Participants	3 Participants	4 Participants	4 Participants	3 Participants	7 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD3; Baseline; n=40,41,43,41,41,40	1 Participants	4 Participants	3 Participants	8 Participants	3 Participants	6 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD3; Week 4; n=37,38,38,38,30,32	2 Participants	4 Participants	1 Participants	6 Participants	3 Participants	6 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD3; Week 8; n=34,37,34,38,29,27	2 Participants	2 Participants	4 Participants	5 Participants	3 Participants	5 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD3; Week 12; n=35,37,32,35,28,27	1 Participants	2 Participants	2 Participants	4 Participants	2 Participants	5 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD3; post-screen; n=38,39,38,39,30,32	4 Participants	6 Participants	7 Participants	8 Participants	5 Participants	9 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD3 treg flow cyto; Week 4; n=37,38,37,37,30,30	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD3 treg flow cyto; Week8; n=33,36,33,38,29,26	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD3+CD8+; Week 12; n= 35,37,32,35,28,27	1 Participants	1 Participants	4 Participants	3 Participants	3 Participants	4 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD3+CD8+; post-screen; n=38,39,38,39,30,32	4 Participants	5 Participants	6 Participants	8 Participants	4 Participants	8 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD3+CD8+tregflowcyto;Baseline;n= 38,40,42,39,40,37	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD3+CD8+tregflowcyto;Week8;n=33,36,33,38,29,26	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD3+CD8+tregflowcyto;Week12;n=34,37,32,34,27,25	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD3+CD4+; Week 4; n=37,38,38,38,30,32	3 Participants	3 Participants	1 Participants	5 Participants	4 Participants	3 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD3+CD4+; Week 8; n=34,37,34,38,29,27	5 Participants	6 Participants	3 Participants	4 Participants	6 Participants	3 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD3+CD4+tregflow cyto;Baseline;n=38,40,42,39,40,37	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD3+CD4+tregflow cyto;Week4;n=37,38,37,37, 30,30	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD3+CD4+tregflow cyto;Week8;n=33,36,33,38,29,26	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD3+CD4+tregflow cyto;Week12;n=34,37,32,34,27,25	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD3+CD4+tregflow;postscreen;n=38,39,38,39,30,32	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD16+CD56+;Baseline;n=40,41,43,40,41,40	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants	2 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD16+CD56+;Week4;n=37,38,38,38,30,32	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD16+CD56+;Week8;n=34,37,34,38,29,27	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD16+CD56+;postscreen;n=38,39,38,39,30,32	1 Participants	1 Participants	1 Participants	1 Participants	2 Participants	3 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD3+CD4+CD25+CD127;Baseline;n=38,40,42,39,40,37	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD3+CD4+CD25+CD127;Week 4;n=37,38,37,37,30,30	3 Participants	4 Participants	1 Participants	3 Participants	2 Participants	1 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD3+CD4+CD25+CD127;Week8;n=33,36,33,38,29,26	6 Participants	2 Participants	4 Participants	4 Participants	3 Participants	3 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD3+CD4+CD25+CD127;Week12;n=34,37,32,34,27,25	6 Participants	5 Participants	5 Participants	4 Participants	4 Participants	6 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD3+CD4+CD25+CD127;postscreen;n=38,39,38,39,30,32	9 Participants	9 Participants	7 Participants	7 Participants	6 Participants	8 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD3+CD4+foxP3+CD25+CD127;Base;n=38,40,42,39,40,37	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD3+CD4+foxP3+CD25+CD127;Week4;n=37,38,37,37,30,30	11 Participants	6 Participants	7 Participants	10 Participants	10 Participants	7 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD3+CD4+foxP3+CD25+CD127;Week8;n=33,36,33,37,29,26	9 Participants	6 Participants	9 Participants	9 Participants	8 Participants	14 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD3+CD4+foxP3+CD25+CD127;Week12;34,37,32,34,27,25	14 Participants	8 Participants	6 Participants	10 Participants	9 Participants	9 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD3+CD4+foxP3+CD25+CD127;post;n=38,39,38,39,30,32	22 Participants	16 Participants	13 Participants	19 Participants	19 Participants	21 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range T-B cell NK lympho;Baseline; n=40,41,43,40,41,40	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	2 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range T-B cell NK lympho;Week4; n=37,38,38,38,30,32	0 Participants	2 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range T-B cell NK lympho;Week8;n=34,37,34,38,29,27	2 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range T-B cell NK lympho;Week12;n=35,37,32,35,28,27	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range T-B cell NK lympho;postscreen;n=38,39,38,39,30,32	2 Participants	5 Participants	0 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD19; Week 12; n= 35,37,32,35,28,27	3 Participants	0 Participants	1 Participants	1 Participants	3 Participants	3 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD3 treg flow cyto;Baseline; n=38,40,42,39,40,37	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD3 treg flow cyto; Week 12; n= 34,37,32,34,27,25	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD3treg flow cyto; postscreen; n=38,39,38,39,30,32	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD3+CD8+; Baseline; n= 40,41,43,40,41,40	2 Participants	5 Participants	4 Participants	9 Participants	3 Participants	3 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD3+CD8+; Week 4; n=37,38,38,38,30,32	3 Participants	3 Participants	3 Participants	5 Participants	3 Participants	4 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD3+CD8+; Week 8; n=34,37,34,38,29,27	2 Participants	1 Participants	3 Participants	4 Participants	2 Participants	4 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD3+CD8+tregflowcyto;Week4;n=37,38,37,37,30,30	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD3+CD8+tregflowcytopostscreen;n=38,39,38,39,30,32	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD3+CD4+; Baseline;n=40,41,43,40,41,40	3 Participants	4 Participants	2 Participants	8 Participants	5 Participants	6 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD3+CD4+; Week 12; n= 35,37,32,35,28,27	2 Participants	7 Participants	4 Participants	5 Participants	6 Participants	5 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD3+CD4+; post-screen;n=38,39,38,39,30,32	7 Participants	9 Participants	7 Participants	8 Participants	8 Participants	7 Participants
Number of Participants With Immunopheotyping Data Outside the Reference Range CD16+CD56+;Week12;n=35,37,32,35,28,27	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants

SECONDARY outcome

Timeframe: Week, 4, 8 and 12

Population: Safety population

Blood samples were collected to evaluate change from Baseline in IgA, IgG, IM values at Baseline throughout the 12 weeks of study treatment. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.

Outcome measures

Outcome measures
Measure	GSK2894512 0.5% QD n=41 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=42 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=40 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	GSK2894512 1% BID n=40 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=41 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=43 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels IgA; Week 4; n= 37,38,38,38,30,32	-0.026 G/L Standard Deviation 0.2342	-0.046 G/L Standard Deviation 0.2179	-0.045 G/L Standard Deviation 0.3141	-0.016 G/L Standard Deviation 0.2528	-0.103 G/L Standard Deviation 0.2108	-0.079 G/L Standard Deviation 0.2003
Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels IgA; Week 8; n= 35,37,34,38,29,28	0.035 G/L Standard Deviation 0.2188	0.026 G/L Standard Deviation 0.2695	-0.036 G/L Standard Deviation 0.3106	-0.064 G/L Standard Deviation 0.2558	-0.116 G/L Standard Deviation 0.2314	-0.056 G/L Standard Deviation 0.2570
Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels IgA; Week 12; n= 36,37,32,35,28,27	-0.042 G/L Standard Deviation 0.2657	-0.038 G/L Standard Deviation 0.1744	-0.016 G/L Standard Deviation 0.2462	-0.056 G/L Standard Deviation 0.2820	-0.099 G/L Standard Deviation 0.6148	-0.140 G/L Standard Deviation 0.2207
Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels IgG; Week 4; n= 37,38,38,38,30,32	-0.347 G/L Standard Deviation 1.1148	-0.198 G/L Standard Deviation 1.2753	-0.112 G/L Standard Deviation 1.1564	-0.130 G/L Standard Deviation 1.0945	-0.446 G/L Standard Deviation 0.8854	-0.282 G/L Standard Deviation 1.2618
Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels IgG; Week 8; n= 35,37,34,38,29,28	-0.200 G/L Standard Deviation 1.1449	0.428 G/L Standard Deviation 1.1984	0.203 G/L Standard Deviation 1.4037	-0.007 G/L Standard Deviation 1.2785	-0.457 G/L Standard Deviation 1.0787	-0.121 G/L Standard Deviation 1.4233
Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels IgG; Week 12; n= 36,37,32,35,28,27	-0.269 G/L Standard Deviation 0.9239	0.256 G/L Standard Deviation 1.5915	0.331 G/L Standard Deviation 0.8796	-0.033 G/L Standard Deviation 1.2978	-0.436 G/L Standard Deviation 3.8561	-0.367 G/L Standard Deviation 1.0214
Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels IgM; Week 4; n=37,38,38,38,30,32	-0.043 G/L Standard Deviation 0.1303	-0.052 G/L Standard Deviation 0.0933	-0.040 G/L Standard Deviation 0.0886	-0.049 G/L Standard Deviation 0.1524	-0.102 G/L Standard Deviation 0.1514	-0.077 G/L Standard Deviation 0.0968
Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels IgM; Week 8; n= 35,37,34,38,29,28	-0.052 G/L Standard Deviation 0.1167	-0.014 G/L Standard Deviation 0.1396	-0.040 G/L Standard Deviation 0.0956	-0.070 G/L Standard Deviation 0.1069	-0.095 G/L Standard Deviation 0.1314	-0.111 G/L Standard Deviation 0.1290
Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels IgM; Week 12; n= 36,37,32,35,28,27	-0.072 G/L Standard Deviation 0.1112	-0.047 G/L Standard Deviation 0.1300	-0.034 G/L Standard Deviation 0.0850	-0.055 G/L Standard Deviation 0.1852	-0.098 G/L Standard Deviation 0.1955	-0.125 G/L Standard Deviation 0.1233

SECONDARY outcome

Timeframe: Baseline, Week, 4, 8, 12, post-screen (up to Week 16)

Population: Safety population

Blood samples were collected from participants for evaluation of immunoglobulin data outside the reference range at Baseline, Week 4, Week 8, Week 12 and any visit post-screen. The immunoglobulin parameters included IgA, IgG and Ig M. Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	GSK2894512 0.5% QD n=41 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=42 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=40 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	GSK2894512 1% BID n=40 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=41 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=43 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
Number of Participants With Immunoglobulin Data Outside the Reference Range IgA; Baseline; n= 40,41,43,41,42,40	1 Participants	4 Participants	2 Participants	2 Participants	3 Participants	2 Participants
Number of Participants With Immunoglobulin Data Outside the Reference Range IgA; Week 4; n= 37,38,38,38,30,32	0 Participants	3 Participants	2 Participants	2 Participants	2 Participants	3 Participants
Number of Participants With Immunoglobulin Data Outside the Reference Range IgA; Week 8; n= 35,37,34,38,29,28	2 Participants	1 Participants	2 Participants	2 Participants	1 Participants	3 Participants
Number of Participants With Immunoglobulin Data Outside the Reference Range IgA; Week 12; n= 36,37,32,35,28,27	1 Participants	1 Participants	2 Participants	3 Participants	1 Participants	4 Participants
Number of Participants With Immunoglobulin Data Outside the Reference Range IgA; post-screen; n= 38,39,38,39,30,32	2 Participants	3 Participants	3 Participants	4 Participants	3 Participants	4 Participants
Number of Participants With Immunoglobulin Data Outside the Reference Range IgG; Baseline; n=40,41,43,41,42,40	4 Participants	3 Participants	3 Participants	2 Participants	5 Participants	1 Participants
Number of Participants With Immunoglobulin Data Outside the Reference Range IgG; Week 4; n= 37,38,38,38,30,32	3 Participants	3 Participants	2 Participants	1 Participants	3 Participants	0 Participants
Number of Participants With Immunoglobulin Data Outside the Reference Range IgG; Week 8; n=35,37,34,38,29,28	3 Participants	4 Participants	2 Participants	3 Participants	3 Participants	0 Participants
Number of Participants With Immunoglobulin Data Outside the Reference Range IgG; Week 12; n=36,37,32,35,28,27	5 Participants	4 Participants	2 Participants	4 Participants	5 Participants	0 Participants
Number of Participants With Immunoglobulin Data Outside the Reference Range IgG; post screen; n= 38,39,38,39,30,32	5 Participants	6 Participants	3 Participants	4 Participants	6 Participants	0 Participants
Number of Participants With Immunoglobulin Data Outside the Reference Range IgM;Baseline; n= 40,41,43,41,42,40	3 Participants	6 Participants	4 Participants	4 Participants	7 Participants	3 Participants
Number of Participants With Immunoglobulin Data Outside the Reference Range IgM; Week 4; n=37,38,38,38,30,32	1 Participants	2 Participants	6 Participants	3 Participants	5 Participants	6 Participants
Number of Participants With Immunoglobulin Data Outside the Reference Range IgM; Week 8; n= 35,37,34,38,29,28	3 Participants	3 Participants	5 Participants	3 Participants	4 Participants	7 Participants
Number of Participants With Immunoglobulin Data Outside the Reference Range IgM; Week12; n= 36,37,32,35,28,27	2 Participants	3 Participants	6 Participants	4 Participants	5 Participants	7 Participants
Number of Participants With Immunoglobulin Data Outside the Reference Range IgM; post-screen; n=38,39,38,39,30,32	4 Participants	3 Participants	6 Participants	4 Participants	5 Participants	10 Participants

SECONDARY outcome

Timeframe: Week 1, 2, 4, 8, 12, 14, EW (up to week 14)

Population: Safety Population

SBP and DBP were measured from Baseline up to follow up Visit 1 at Week 14 in semi-supine position after at least 5 minutes of rest. The Baseline value was taken at Day 1 and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.

Outcome measures

Outcome measures
Measure	GSK2894512 0.5% QD n=41 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=42 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=40 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	GSK2894512 1% BID n=40 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=41 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=43 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP; Week 1; n= 38,31,39,37,38,33	-1.9 Millimeter of mercury (mmHg) Standard Deviation 9.77	0.8 Millimeter of mercury (mmHg) Standard Deviation 9.32	-0.7 Millimeter of mercury (mmHg) Standard Deviation 9.45	-1.6 Millimeter of mercury (mmHg) Standard Deviation 8.89	-2.3 Millimeter of mercury (mmHg) Standard Deviation 11.02	-2.3 Millimeter of mercury (mmHg) Standard Deviation 14.72
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP; Week 2; n=39,39,39,39,33,32	-1.2 Millimeter of mercury (mmHg) Standard Deviation 11.41	-0.8 Millimeter of mercury (mmHg) Standard Deviation 10.41	-1.6 Millimeter of mercury (mmHg) Standard Deviation 6.90	-1.7 Millimeter of mercury (mmHg) Standard Deviation 12.22	0.6 Millimeter of mercury (mmHg) Standard Deviation 10.57	-4.3 Millimeter of mercury (mmHg) Standard Deviation 13.37
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP; Week 4; n= 38,39,38,39,30,32	-1.8 Millimeter of mercury (mmHg) Standard Deviation 11.94	1.9 Millimeter of mercury (mmHg) Standard Deviation 13.33	-0.5 Millimeter of mercury (mmHg) Standard Deviation 14.24	-1.7 Millimeter of mercury (mmHg) Standard Deviation 10.57	0.5 Millimeter of mercury (mmHg) Standard Deviation 10.00	-3.8 Millimeter of mercury (mmHg) Standard Deviation 9.05
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP; Week 8; n= 36,37,34,38,29,28	-1.9 Millimeter of mercury (mmHg) Standard Deviation 9.86	0.0 Millimeter of mercury (mmHg) Standard Deviation 11.29	1.0 Millimeter of mercury (mmHg) Standard Deviation 17.08	-1.9 Millimeter of mercury (mmHg) Standard Deviation 10.74	-0.5 Millimeter of mercury (mmHg) Standard Deviation 11.27	-4.3 Millimeter of mercury (mmHg) Standard Deviation 11.38
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP; Week 12; n= 36,37,32,35,28,28	-2.4 Millimeter of mercury (mmHg) Standard Deviation 10.71	-0.5 Millimeter of mercury (mmHg) Standard Deviation 10.44	-0.5 Millimeter of mercury (mmHg) Standard Deviation 12.67	-3.1 Millimeter of mercury (mmHg) Standard Deviation 10.28	-0.1 Millimeter of mercury (mmHg) Standard Deviation 11.64	-1.9 Millimeter of mercury (mmHg) Standard Deviation 12.62
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP; Week 14; n=34,35,32,34,31,29	-1.9 Millimeter of mercury (mmHg) Standard Deviation 9.46	1.2 Millimeter of mercury (mmHg) Standard Deviation 13.18	0.3 Millimeter of mercury (mmHg) Standard Deviation 11.29	-1.0 Millimeter of mercury (mmHg) Standard Deviation 11.95	-0.5 Millimeter of mercury (mmHg) Standard Deviation 12.52	-1.4 Millimeter of mercury (mmHg) Standard Deviation 12.76
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP; EW; n= 3,4,7,3,11,11	-0.7 Millimeter of mercury (mmHg) Standard Deviation 7.37	1.2 Millimeter of mercury (mmHg) Standard Deviation 8.81	2.0 Millimeter of mercury (mmHg) Standard Deviation 6.96	5.3 Millimeter of mercury (mmHg) Standard Deviation 8.08	-5.3 Millimeter of mercury (mmHg) Standard Deviation 18.01	4.9 Millimeter of mercury (mmHg) Standard Deviation 13.63
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP; Week 1; n=38,31,39,37,38,33	-1.5 Millimeter of mercury (mmHg) Standard Deviation 7.33	1.1 Millimeter of mercury (mmHg) Standard Deviation 9.29	-0.4 Millimeter of mercury (mmHg) Standard Deviation 7.53	-2.0 Millimeter of mercury (mmHg) Standard Deviation 8.55	1.4 Millimeter of mercury (mmHg) Standard Deviation 8.48	-1.9 Millimeter of mercury (mmHg) Standard Deviation 8.74
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP; Week 2; n=39,39,39,39,33,32	-3.3 Millimeter of mercury (mmHg) Standard Deviation 7.07	-2.2 Millimeter of mercury (mmHg) Standard Deviation 10.29	-0.9 Millimeter of mercury (mmHg) Standard Deviation 5.97	-3.4 Millimeter of mercury (mmHg) Standard Deviation 9.60	0.1 Millimeter of mercury (mmHg) Standard Deviation 8.14	-3.7 Millimeter of mercury (mmHg) Standard Deviation 7.63
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP; Week 4; n=38,39,38,39,30,32	-4.0 Millimeter of mercury (mmHg) Standard Deviation 7.98	-0.1 Millimeter of mercury (mmHg) Standard Deviation 10.49	1.9 Millimeter of mercury (mmHg) Standard Deviation 9.18	-3.0 Millimeter of mercury (mmHg) Standard Deviation 12.21	0.9 Millimeter of mercury (mmHg) Standard Deviation 7.98	-3.1 Millimeter of mercury (mmHg) Standard Deviation 9.31
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP; Week 8; n=36,37,34,38,29,28	-2.1 Millimeter of mercury (mmHg) Standard Deviation 8.91	-0.2 Millimeter of mercury (mmHg) Standard Deviation 10.10	2.2 Millimeter of mercury (mmHg) Standard Deviation 10.08	-4.8 Millimeter of mercury (mmHg) Standard Deviation 9.79	1.0 Millimeter of mercury (mmHg) Standard Deviation 8.07	-3.3 Millimeter of mercury (mmHg) Standard Deviation 9.24
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP; Week 12; n= 36,37,32,35,28,28	-4.0 Millimeter of mercury (mmHg) Standard Deviation 9.18	0.9 Millimeter of mercury (mmHg) Standard Deviation 9.81	1.3 Millimeter of mercury (mmHg) Standard Deviation 8.93	-6.5 Millimeter of mercury (mmHg) Standard Deviation 8.86	2.6 Millimeter of mercury (mmHg) Standard Deviation 7.02	-2.8 Millimeter of mercury (mmHg) Standard Deviation 8.82
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP; Week 14; n= 34,35,32,34,31,29	-0.4 Millimeter of mercury (mmHg) Standard Deviation 8.49	-0.4 Millimeter of mercury (mmHg) Standard Deviation 9.45	0.9 Millimeter of mercury (mmHg) Standard Deviation 7.75	-5.6 Millimeter of mercury (mmHg) Standard Deviation 9.23	-0.5 Millimeter of mercury (mmHg) Standard Deviation 7.71	-2.9 Millimeter of mercury (mmHg) Standard Deviation 9.10
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP; EW; n= 3,4,7,3,11,11	-1.0 Millimeter of mercury (mmHg) Standard Deviation 9.54	2.3 Millimeter of mercury (mmHg) Standard Deviation 3.66	-2.7 Millimeter of mercury (mmHg) Standard Deviation 7.02	3.3 Millimeter of mercury (mmHg) Standard Deviation 3.06	1.3 Millimeter of mercury (mmHg) Standard Deviation 3.40	0.0 Millimeter of mercury (mmHg) Standard Deviation 10.82

SECONDARY outcome

Timeframe: Week 1, 2, 4, 8, 12, 14, EW (up to week 14)

Population: Safety Population

Pulse rate were measured from Baseline up to follow up Visit 1 at Week 14 in semi-supine position after at least 5 minutes of rest. The Baseline value was taken at Day 1 and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.

Outcome measures

Outcome measures
Measure	GSK2894512 0.5% QD n=41 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=42 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=40 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	GSK2894512 1% BID n=40 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=41 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=43 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
Change From Baseline in Pulse Rate Week 1; n= 38,41,39,37,38,33	-0.4 Beats per minute (bpm) Standard Deviation 9.39	0.4 Beats per minute (bpm) Standard Deviation 9.43	-0.4 Beats per minute (bpm) Standard Deviation 9.82	5.8 Beats per minute (bpm) Standard Deviation 9.19	2.5 Beats per minute (bpm) Standard Deviation 8.68	0.8 Beats per minute (bpm) Standard Deviation 10.19
Change From Baseline in Pulse Rate Week 2; n= 39,39,39,39,33,32	1.0 Beats per minute (bpm) Standard Deviation 10.90	1.5 Beats per minute (bpm) Standard Deviation 11.99	1.0 Beats per minute (bpm) Standard Deviation 10.47	3.7 Beats per minute (bpm) Standard Deviation 10.67	2.3 Beats per minute (bpm) Standard Deviation 10.90	0.1 Beats per minute (bpm) Standard Deviation 9.63
Change From Baseline in Pulse Rate Week 4; n= 38,39,38,39,30,32	0.4 Beats per minute (bpm) Standard Deviation 10.88	-1.7 Beats per minute (bpm) Standard Deviation 11.67	0.1 Beats per minute (bpm) Standard Deviation 8.42	6.2 Beats per minute (bpm) Standard Deviation 10.02	0.6 Beats per minute (bpm) Standard Deviation 10.79	-0.3 Beats per minute (bpm) Standard Deviation 12.30
Change From Baseline in Pulse Rate Week 8; n= 36,37,34,38,29,28	3.2 Beats per minute (bpm) Standard Deviation 11.23	-0.2 Beats per minute (bpm) Standard Deviation 11.45	0.8 Beats per minute (bpm) Standard Deviation 8.97	4.1 Beats per minute (bpm) Standard Deviation 9.72	0.6 Beats per minute (bpm) Standard Deviation 10.27	-1.7 Beats per minute (bpm) Standard Deviation 9.59
Change From Baseline in Pulse Rate Week 12; n= 36,37,32,35,28,28	0.4 Beats per minute (bpm) Standard Deviation 9.74	-1.9 Beats per minute (bpm) Standard Deviation 9.58	1.3 Beats per minute (bpm) Standard Deviation 10.76	3.0 Beats per minute (bpm) Standard Deviation 10.03	-0.0 Beats per minute (bpm) Standard Deviation 11.55	0.0 Beats per minute (bpm) Standard Deviation 10.08
Change From Baseline in Pulse Rate Week 14; n= 34,35,32,34,31,29	2.5 Beats per minute (bpm) Standard Deviation 10.97	0.8 Beats per minute (bpm) Standard Deviation 11.06	0.7 Beats per minute (bpm) Standard Deviation 8.56	3.3 Beats per minute (bpm) Standard Deviation 9.38	3.5 Beats per minute (bpm) Standard Deviation 11.65	0.6 Beats per minute (bpm) Standard Deviation 10.00
Change From Baseline in Pulse Rate EW; n= 3,4,7,3,11,11	-2.7 Beats per minute (bpm) Standard Deviation 8.96	4.2 Beats per minute (bpm) Standard Deviation 12.18	-0.5 Beats per minute (bpm) Standard Deviation 9.15	-13.7 Beats per minute (bpm) Standard Deviation 1.15	0.3 Beats per minute (bpm) Standard Deviation 3.50	-6.0 Beats per minute (bpm) Standard Deviation 9.83

SECONDARY outcome

Timeframe: Week 1, 2, 4, 8, 12, 14, EW (up to week 14)

Population: Safety Population

Temperature were measured from Baseline up to follow up Visit 1 at Week 14 in semi-supine position after at least 5 minutes of rest. The Baseline value was taken at Day 1 and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.

Outcome measures

Outcome measures
Measure	GSK2894512 0.5% QD n=41 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=42 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=40 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	GSK2894512 1% BID n=40 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=41 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=43 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
Change From Baseline in Temperature Week 1; n= 38,41,39, 37,38,33	-0.006 Degree Celsius Standard Deviation 0.3932	-0.053 Degree Celsius Standard Deviation 0.7928	-0.024 Degree Celsius Standard Deviation 0.2693	0.013 Degree Celsius Standard Deviation 0.3640	-0.056 Degree Celsius Standard Deviation 0.2618	0.015 Degree Celsius Standard Deviation 0.3689
Change From Baseline in Temperature Week 2; n=39,39,39,39,32,32	-0.069 Degree Celsius Standard Deviation 0.4691	-0.097 Degree Celsius Standard Deviation 0.7082	0.016 Degree Celsius Standard Deviation 0.2841	-0.054 Degree Celsius Standard Deviation 0.4973	-0.064 Degree Celsius Standard Deviation 0.2680	0.005 Degree Celsius Standard Deviation 0.3332
Change From Baseline in Temperature Week 4; n= 38,39,38,39,30,32	-0.068 Degree Celsius Standard Deviation 0.4902	-0.030 Degree Celsius Standard Deviation 0.6706	0.013 Degree Celsius Standard Deviation 0.2459	-0.074 Degree Celsius Standard Deviation 0.4428	-0.023 Degree Celsius Standard Deviation 0.3256	-0.013 Degree Celsius Standard Deviation 0.3458
Change From Baseline in Temperature Week 8; n= 36,37,34,38,29,28	0.045 Degree Celsius Standard Deviation 0.4011	0.062 Degree Celsius Standard Deviation 0.7566	0.021 Degree Celsius Standard Deviation 0.3304	0.006 Degree Celsius Standard Deviation 0.4276	-0.024 Degree Celsius Standard Deviation 0.2671	-0.056 Degree Celsius Standard Deviation 0.3295
Change From Baseline in Temperature Week 12; n=36,37,32,35,28,28	-0.040 Degree Celsius Standard Deviation 0.4532	0.043 Degree Celsius Standard Deviation 0.7618	0.004 Degree Celsius Standard Deviation 0.4574	0.003 Degree Celsius Standard Deviation 0.4212	-0.068 Degree Celsius Standard Deviation 0.3292	-0.078 Degree Celsius Standard Deviation 0.2814
Change From Baseline in Temperature Week 14;n=34,35,32,34,31,29	-0.109 Degree Celsius Standard Deviation 0.4876	-0.013 Degree Celsius Standard Deviation 0.8740	-0.052 Degree Celsius Standard Deviation 0.3582	-0.079 Degree Celsius Standard Deviation 0.4059	-0.131 Degree Celsius Standard Deviation 0.6416	-0.059 Degree Celsius Standard Deviation 0.3618
Change From Baseline in Temperature EW; n= 3,4,7,3,11,11	0.400 Degree Celsius Standard Deviation 0.5568	-0.182 Degree Celsius Standard Deviation 0.5212	0.164 Degree Celsius Standard Deviation 0.4985	-0.033 Degree Celsius Standard Deviation 0.1528	0.000 Degree Celsius Standard Deviation 0.3651	0.100 Degree Celsius Standard Deviation 0.2517

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12, 14, EW (up to week 14)

Population: Safety Population

Blood samples were collected from participants for evaluation of vital signs by Potential Clinical Importance Criteria from Baseline to Week 14, EW and any visit post-screen. The vital signs included SBP, DBP and pulse rate. Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	GSK2894512 0.5% QD n=41 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=42 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=40 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	GSK2894512 1% BID n=40 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=41 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=43 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
Number of Participants With Vital Signs of Potential Clinical Importance DBP; Week 4; n=38,39,38,39,30,32	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Vital Signs of Potential Clinical Importance DBP; Week 8; n= 36,37,34,38,29,28	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Vital Signs of Potential Clinical Importance SBP; Baseline; n= 40,41,43,41,42,40	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Vital Signs of Potential Clinical Importance SBP; Week 1; n= 38,41,39,37,38,33	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Vital Signs of Potential Clinical Importance SBP; Week 2; n= 39,39,39,39,33,32	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Vital Signs of Potential Clinical Importance SBP; Week 8; n= 36,37,34,38,29,28	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Vital Signs of Potential Clinical Importance SBP; Week 12; n= 36,37,32,35,28,28	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Vital Signs of Potential Clinical Importance SBP: Week 14; n= 34,35,32,34,31,29	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Vital Signs of Potential Clinical Importance SBP; EW; n= 3,4,7,3,11,11	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Vital Signs of Potential Clinical Importance SBP; post-screen; n= 40,41,43,41,42,40	3 Participants	0 Participants	3 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Vital Signs of Potential Clinical Importance DBP; Week 1; n=38,41,39,37,38,33	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Vital Signs of Potential Clinical Importance DBP; Week 2; n=39,39,39,39,33,32	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Vital Signs of Potential Clinical Importance DBP; Week 12; n= 36,37,32,35,28,28	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Vital Signs of Potential Clinical Importance DBP; Week 14; n= 34,35,32,34,31,29	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Vital Signs of Potential Clinical Importance DBP; EW; n= 3,4,7,3,11,11	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Vital Signs of Potential Clinical Importance DBP; post-screen; n= 40,41,43,41,42,40	1 Participants	1 Participants	2 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Vital Signs of Potential Clinical Importance Pulse rate; Baseline; n= 40,41,43,41,42,40	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Vital Signs of Potential Clinical Importance Pulse rate; Week 1; n= 38,41,39,37,38,33	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Vital Signs of Potential Clinical Importance Pulse rate;Week 2; n= 39,39,39,39,33,32	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Vital Signs of Potential Clinical Importance Pulse rate; Week 4; n= 38,39,38,39,30,32	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Vital Signs of Potential Clinical Importance Pulse rate; Week 8; n= 36,37,34,38,29,28	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Vital Signs of Potential Clinical Importance Pulse rate; Week 12; n= 36,37,32,35,28,28	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Vital Signs of Potential Clinical Importance Pulse rate; Week 14; n= 34,35,32,34,31,29	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Vital Signs of Potential Clinical Importance Pulse rate; EW; n= 3,4,7,3,11,11	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Vital Signs of Potential Clinical Importance Pulse rate; post-screen; n=40,41,43,41,42,40	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Vital Signs of Potential Clinical Importance SBP; Week 4; n= 38,39,38,39,30,32	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Vital Signs of Potential Clinical Importance DBP; Baseline; n= 40,41,43,41,42,40	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 1, 12, 14, EW ( up to Week 14), post-screen

Population: Safety population

Single measurements of 12-lead ECGs were obtained at Baseline , Week 1, Week 12, Week 14 (follow up 1), EW and at any time post-screen using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT (QTc). Baseline was defined as the latest assessment prior to the first dose. For multiple ECGs at one visit, or "Any visit post-screen", a participant was categorized as "Abnormal" if \>=1 assessment was abnormal. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	GSK2894512 0.5% QD n=41 Participants Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	Vehicle BID n=42 Participants Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks	Vehicle QD n=40 Participants Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks	GSK2894512 1% BID n=40 Participants Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks.	GSK2894512 1% QD n=41 Participants Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks.	GSK2894512 0.5% BID n=43 Participants Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Baseline; n= 40,41,43,41,42,40	5 Participants	5 Participants	5 Participants	8 Participants	6 Participants	4 Participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Week 1; n= 37,41,39,37,38,33	5 Participants	5 Participants	6 Participants	8 Participants	8 Participants	4 Participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Week 12; n= 36,37,32,35,28,28	3 Participants	1 Participants	4 Participants	7 Participants	6 Participants	4 Participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Week 14; n= 34,34,32,34,31,29	6 Participants	1 Participants	5 Participants	8 Participants	4 Participants	5 Participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings EW; n= 3,3,7,3,10,11	2 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings post-screen; n= 40,41,41,39,41,40	8 Participants	5 Participants	9 Participants	12 Participants	10 Participants	5 Participants

Adverse Events

GSK2894512 1% Cream Twice Daily

Serious events: 1 serious events

Other events: 28 other events

Deaths: 0 deaths

GSK2894512 1% Cream Once Daily

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

GSK2894512 0.5% Cream Twice Daily

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

GSK2894512 0.5% Cream Once Daily

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Vehicle Cream Twice Daily

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Vehicle Cream Once Daily

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	GSK2894512 1% Cream Twice Daily n=40 participants at risk Subjects will apply a thin layer of GSK2894512 1% (10 milligram per gram \[mg/g\]) topical cream twice daily (morning and evening) for 12 weeks, to all atopic dermatitis lesions (except on the scalp).	GSK2894512 1% Cream Once Daily n=41 participants at risk Subjects will apply a thin layer of GSK2894512 1% (10 mg/g) topical cream once daily (evening) for 12 weeks, to all atopic dermatitis lesions (except on the scalp).	GSK2894512 0.5% Cream Twice Daily n=43 participants at risk Subjects will apply a thin layer of GSK2894512 0.5% (5 mg/g) topical cream twice daily (morning and evening) for 12 weeks, to all atopic dermatitis lesions (except on the scalp).	GSK2894512 0.5% Cream Once Daily n=41 participants at risk Subjects will apply a thin layer of GSK2894512 0.5% (5 mg/g) topical cream once daily (evening) for 12 weeks, to all atopic dermatitis lesions (except on the scalp).	Vehicle Cream Twice Daily n=42 participants at risk Subjects will apply a thin layer of vehicle topical cream twice daily (morning and evening) for 12 weeks, to all atopic dermatitis lesions (except on the scalp).	Vehicle Cream Once Daily n=40 participants at risk Subjects will apply a thin layer of vehicle topical cream once daily (evening) for 12 weeks, to all atopic dermatitis lesions (except on the scalp).
Psychiatric disorders Anxiety	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Psychiatric disorders Attention deficit /hyperactivity disorder	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.

Other adverse events

Other adverse events
Measure	GSK2894512 1% Cream Twice Daily n=40 participants at risk Subjects will apply a thin layer of GSK2894512 1% (10 milligram per gram \[mg/g\]) topical cream twice daily (morning and evening) for 12 weeks, to all atopic dermatitis lesions (except on the scalp).	GSK2894512 1% Cream Once Daily n=41 participants at risk Subjects will apply a thin layer of GSK2894512 1% (10 mg/g) topical cream once daily (evening) for 12 weeks, to all atopic dermatitis lesions (except on the scalp).	GSK2894512 0.5% Cream Twice Daily n=43 participants at risk Subjects will apply a thin layer of GSK2894512 0.5% (5 mg/g) topical cream twice daily (morning and evening) for 12 weeks, to all atopic dermatitis lesions (except on the scalp).	GSK2894512 0.5% Cream Once Daily n=41 participants at risk Subjects will apply a thin layer of GSK2894512 0.5% (5 mg/g) topical cream once daily (evening) for 12 weeks, to all atopic dermatitis lesions (except on the scalp).	Vehicle Cream Twice Daily n=42 participants at risk Subjects will apply a thin layer of vehicle topical cream twice daily (morning and evening) for 12 weeks, to all atopic dermatitis lesions (except on the scalp).	Vehicle Cream Once Daily n=40 participants at risk Subjects will apply a thin layer of vehicle topical cream once daily (evening) for 12 weeks, to all atopic dermatitis lesions (except on the scalp).
Infections and infestations Oral herpes	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Milia	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Vascular disorders Hypertension	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Infections and infestations Nasopharyngitis	7.5% 3/40 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	12.2% 5/41 • Number of events 6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	9.3% 4/43 • Number of events 5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	9.5% 4/42 • Number of events 4 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	7.5% 3/40 • Number of events 5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Infections and infestations Folliculitis	10.0% 4/40 • Number of events 4 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	19.5% 8/41 • Number of events 8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	7.0% 3/43 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	7.3% 3/41 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Infections and infestations Upper respiratory	10.0% 4/40 • Number of events 5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	4.9% 2/41 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	7.0% 3/43 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	4.9% 2/41 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	7.1% 3/42 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Infections and infestations Influenza	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.3% 1/43 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/42 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Infections and infestations Impetigo	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	7.5% 3/40 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Infections and infestations Gastroenteritis viral	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.3% 1/43 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Infections and infestations Bronchitis	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	4.7% 2/43 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Infections and infestations Conjunctivitis	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Infections and infestations Gastroenteritis	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Infections and infestations Sinusitis	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Infections and infestations Body tinea	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Infections and infestations Chronic sinusitis	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Infections and infestations Eczema impetiginous	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Infections and infestations External ear cellulitis	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Infections and infestations Fungal infection	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Infections and infestations Gastrointestinal infection	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Infections and infestations Herpes simplex	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.3% 1/43 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Infections and infestations Otitis externa	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Infections and infestations Pharyngotonsillitis	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Infections and infestations Staphylococcal impetigo	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Infections and infestations Staphylococcal infection	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Infections and infestations Staphylococcal skin infection	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.3% 1/43 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Infections and infestations Superinfection	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.3% 1/43 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Infections and infestations Sycosis barbae	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.3% 1/43 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Infections and infestations Tooth abscess	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Infections and infestations Urinary tract infection	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/42 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/42 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Dermatitis atopic	5.0% 2/40 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	7.0% 3/43 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	9.5% 4/42 • Number of events 4 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	12.5% 5/40 • Number of events 5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Acne	5.0% 2/40 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.3% 1/43 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	7.3% 3/41 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/42 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Dermatitis contact	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.3% 1/43 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/42 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.3% 1/43 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Rash	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/42 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/42 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.3% 1/43 • Number of events 4 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Eczema	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Hyperkeratosis follicularis et parafollicularis	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Pain of skin	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Skin mass	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Nervous system disorders Headache	10.0% 4/40 • Number of events 4 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.3% 1/43 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	7.3% 3/41 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	5.0% 2/40 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Nervous system disorders Burning sensation	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.3% 1/43 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Nervous system disorders Dizziness	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Nervous system disorders Hypoaesthesia	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Nervous system disorders Migraine	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Nervous system disorders Syncope	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
General disorders Application site pain	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.3% 1/43 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	4.8% 2/42 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
General disorders Application site reaction	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.3% 1/43 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Gastrointestinal disorders Cyst	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.3% 1/43 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
General disorders Application site erythema	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/42 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
General disorders Application site oedema	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.3% 1/43 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
General disorders Application site pruritus	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/42 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
General disorders Chest discomfort	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
General disorders Local reaction	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
General disorders Oedema peripheral	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.3% 1/43 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Gastrointestinal disorders Diarrhoea	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	4.9% 2/41 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Gastrointestinal disorders Constipation	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Gastrointestinal disorders Dental caries	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Gastrointestinal disorders Haemorrhoids	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Gastrointestinal disorders Lip oedema	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Gastrointestinal disorders Nausea	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Gastrointestinal disorders Toothache	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Gastrointestinal disorders Vomiting	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.3% 1/43 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Investigations Blood creatinine decreased	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/42 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Investigations Laboratory test abnormal	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/42 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Investigations Alanine aminotransferase increased	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Investigations Hepatic enzyme increased	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.3% 1/43 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Investigations Monocyte count decreased	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.3% 1/43 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Investigations Transaminases increased	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/42 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.5% 1/40 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Myalgia	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Arthritis	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Coccydynia	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.3% 1/43 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/42 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Sunburn	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract congestion	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Wheezing	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Immune system disorders Food allergy	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Immune system disorders Hypersensitivity	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Immune system disorders Seasonal allergy	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.3% 1/43 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Lymphadenopathy	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Neutropenia	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Eye disorders Conjunctivitis allergic	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/42 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Eye disorders Dry eye	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Eye disorders Eye ulcer	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/42 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.3% 1/43 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypoglycaemia	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.4% 1/42 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Psychiatric disorders Anxiety	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Psychiatric disorders Attention deficit/hyperactivity disorder	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	2.3% 1/43 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
Reproductive system and breast disorders Dysmenorrhoea	2.5% 1/40 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/43 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.	0.00% 0/40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16. AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.

Additional Information

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GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
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