Trial Outcomes & Findings for Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no. 6). (NCT NCT03526861)

Last Updated: 2025-03-11

Results Overview

The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

301 participants

Primary outcome timeframe

At Week 16

Results posted on

2025-03-11

Participant Flow

Participant milestones

Participant milestones
Measure	Initial Treatment Period - Tralokinumab 300 mg Q2W Week 0 to Week 16: Tralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for SC administration. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.	Initial Treatment Period - Tralokinumab 150 mg Q2W Week 0 to Week 16: Tralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for SC administration. At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.	Initial Treatment Period - Placebo Week 0 to Week 16: Placebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.	Maintenance Treatment Period - Tralokinumab 300 mg Q2W Week 16 to Week 52: Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 and initially randomised to tralokinumab 300 mg Q2W, re-randomised to tralokinumab 300 mg Q2W maintenance dosing regimen. At each visit (Q2W), subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.	Maintenance Treatment Period - Tralokinumab 300 mg Q4W Week 16 to Week 52: Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 and initially randomised to tralokinumab 300 mg Q2W, re-randomised to tralokinumab 300 mg Q4W maintenance dosing regimen. At each visit (Q2W), subject received alternating dose administrations: 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab; or 2 subcutaneous injections (each 1.0 mL) of placebo.	Maintenance Treatment Period - Tralokinumab 150 mg Q2W Week 16 to Week 52: Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 and initially randomised to tralokinumab 150 mg Q2W, re-randomised to tralokinumab 150 mg Q2W maintenance dosing regimen. At each visit (Q2W), subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.	Maintenance Treatment Period - Tralokinumab 150 mg Q4W Week 16 to Week 52: Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 from Week 2 to Week 16 and initially randomised to tralokinumab 150 mg Q2W, re-randomised to tralokinumab 150 mg Q4W maintenance dosing regimen. At each visit (Q2W), subject received alternating dose administrations: 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab; or 2 subcutaneous injections (each 1.0 mL) of placebo.	Maintenance Treatment Period - Placebo Q2W Week 16 to Week 52: Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 and initially randomised to placebo, assigned to continue to placebo Q2W. At each visit (Q2W), subject received 2 subcutaneous injections (each 1.0 mL) of placebo.	Open-label Treatment -Tralokinumab 300 mg Q2W + Optional TCS Week 16 to Week 52: Subjects receiving initial treatment with tralokinumab 150 mg/tralokinumab 300 mg/placebo Q2W who did not achieve clinical response at Week 16 without use of rescue medication from Week 2 to Week 16, assigned to open-label treatment at Week 16 with tralokinumab 300 mg Q2W regimen + optional topical corticosteroids (TCS) OR Subjects receiving maintenance treatment with tralokinumab 150 mg Q2W/Q4W, tralokinumab 300 mg Q2W/Q4W, or placebo Q2W assigned to open-label treatment after Week 16 with tralokinumab 300 mg Q2W regimen + optional TCS if * IGA of at least 2 and not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA=0 at Week 16. * IGA of at least 3 and not achieving EASI75 over at least a 4-week period (i.e. over 3 consecutive visits) for subjects with IGA=1 at Week 16. * Not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA\>1 at Week 16. At each visit, subjects received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg.
Initial Treatment Period STARTED	101	100	100	0	0	0	0	0	0
Initial Treatment Period COMPLETED	94	93	86	0	0	0	0	0	0
Initial Treatment Period NOT COMPLETED	7	7	14	0	0	0	0	0	0
Maintenance Treatment Period STARTED	0	0	0	13	14	12	14	6	0
Maintenance Treatment Period COMPLETED	0	0	0	5	8	8	8	4	0
Maintenance Treatment Period NOT COMPLETED	0	0	0	8	6	4	6	2	0
Open-label Treatment Period STARTED	0	0	0	0	0	0	0	0	242
Open-label Treatment Period COMPLETED	0	0	0	0	0	0	0	0	214
Open-label Treatment Period NOT COMPLETED	0	0	0	0	0	0	0	0	28

Reasons for withdrawal

Reasons for withdrawal
Measure	Initial Treatment Period - Tralokinumab 300 mg Q2W Week 0 to Week 16: Tralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for SC administration. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.	Initial Treatment Period - Tralokinumab 150 mg Q2W Week 0 to Week 16: Tralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for SC administration. At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.	Initial Treatment Period - Placebo Week 0 to Week 16: Placebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.	Maintenance Treatment Period - Tralokinumab 300 mg Q2W Week 16 to Week 52: Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 and initially randomised to tralokinumab 300 mg Q2W, re-randomised to tralokinumab 300 mg Q2W maintenance dosing regimen. At each visit (Q2W), subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.	Maintenance Treatment Period - Tralokinumab 300 mg Q4W Week 16 to Week 52: Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 and initially randomised to tralokinumab 300 mg Q2W, re-randomised to tralokinumab 300 mg Q4W maintenance dosing regimen. At each visit (Q2W), subject received alternating dose administrations: 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab; or 2 subcutaneous injections (each 1.0 mL) of placebo.	Maintenance Treatment Period - Tralokinumab 150 mg Q2W Week 16 to Week 52: Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 and initially randomised to tralokinumab 150 mg Q2W, re-randomised to tralokinumab 150 mg Q2W maintenance dosing regimen. At each visit (Q2W), subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.	Maintenance Treatment Period - Tralokinumab 150 mg Q4W Week 16 to Week 52: Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 from Week 2 to Week 16 and initially randomised to tralokinumab 150 mg Q2W, re-randomised to tralokinumab 150 mg Q4W maintenance dosing regimen. At each visit (Q2W), subject received alternating dose administrations: 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab; or 2 subcutaneous injections (each 1.0 mL) of placebo.	Maintenance Treatment Period - Placebo Q2W Week 16 to Week 52: Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 and initially randomised to placebo, assigned to continue to placebo Q2W. At each visit (Q2W), subject received 2 subcutaneous injections (each 1.0 mL) of placebo.	Open-label Treatment -Tralokinumab 300 mg Q2W + Optional TCS Week 16 to Week 52: Subjects receiving initial treatment with tralokinumab 150 mg/tralokinumab 300 mg/placebo Q2W who did not achieve clinical response at Week 16 without use of rescue medication from Week 2 to Week 16, assigned to open-label treatment at Week 16 with tralokinumab 300 mg Q2W regimen + optional topical corticosteroids (TCS) OR Subjects receiving maintenance treatment with tralokinumab 150 mg Q2W/Q4W, tralokinumab 300 mg Q2W/Q4W, or placebo Q2W assigned to open-label treatment after Week 16 with tralokinumab 300 mg Q2W regimen + optional TCS if * IGA of at least 2 and not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA=0 at Week 16. * IGA of at least 3 and not achieving EASI75 over at least a 4-week period (i.e. over 3 consecutive visits) for subjects with IGA=1 at Week 16. * Not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA\>1 at Week 16. At each visit, subjects received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg.
Initial Treatment Period Not dosed	1	1	1	0	0	0	0	0	0
Initial Treatment Period Randomised at site with quality/GCP issues identified, subject withdrawn from the trial	3	1	5	0	0	0	0	0	0
Initial Treatment Period Subject discontinued IMP before Week 16	3	5	8	0	0	0	0	0	0
Maintenance Treatment Period Subject discontinued IMP between Week 16 and Week 52	0	0	0	1	1	0	1	0	0
Maintenance Treatment Period Subject transferred to open-label treatment	0	0	0	6	5	4	5	2	0
Maintenance Treatment Period Randomised at site with quality/GCP issues identified, subject withdrawn from the trial	0	0	0	1	0	0	0	0	0
Open-label Treatment Period Subject discontinued IMP between Week 16 and Week 52	0	0	0	0	0	0	0	0	19
Open-label Treatment Period Completed treatment (received the last planned dose of IMP) and withdrew from the trial at Week 50	0	0	0	0	0	0	0	0	1
Open-label Treatment Period Randomised at site with quality/GCP issues identified, subject withdrawn from the trial	0	0	0	0	0	0	0	0	8

Baseline Characteristics

Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no. 6).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Initial Treatment Period - Tralokinumab 300 mg Q2W n=101 Participants Week 0 to Week 16: Tralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.	Initial Treatment Period - Tralokinumab 150 mg Q2W n=100 Participants Week 0 to Week 16: Tralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.	Initial Treatment Period - Placebo n=100 Participants Week 0 to Week 16: Placebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.	Total n=301 Participants Total of all reporting groups
Age, Continuous	14.6 years STANDARD_DEVIATION 1.8 • n=5 Participants	14.8 years STANDARD_DEVIATION 1.7 • n=7 Participants	14.4 years STANDARD_DEVIATION 1.6 • n=5 Participants	14.6 years STANDARD_DEVIATION 1.7 • n=4 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	48 Participants n=7 Participants	46 Participants n=5 Participants	146 Participants n=4 Participants
Sex: Female, Male Male	49 Participants n=5 Participants	52 Participants n=7 Participants	54 Participants n=5 Participants	155 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	32 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	89 Participants n=5 Participants	90 Participants n=7 Participants	90 Participants n=5 Participants	269 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized White	59 Participants n=5 Participants	56 Participants n=7 Participants	58 Participants n=5 Participants	173 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	14 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants	34 Participants n=4 Participants
Race/Ethnicity, Customized Asian	21 Participants n=5 Participants	28 Participants n=7 Participants	23 Participants n=5 Participants	72 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Race/Ethnicity, Customized Other	5 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	15 Participants n=4 Participants
Region of Enrollment Canada	21 participants n=5 Participants	19 participants n=7 Participants	12 participants n=5 Participants	52 participants n=4 Participants
Region of Enrollment Netherlands	4 participants n=5 Participants	4 participants n=7 Participants	5 participants n=5 Participants	13 participants n=4 Participants
Region of Enrollment Belgium	2 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants	8 participants n=4 Participants
Region of Enrollment United States	31 participants n=5 Participants	33 participants n=7 Participants	41 participants n=5 Participants	105 participants n=4 Participants
Region of Enrollment Japan	11 participants n=5 Participants	10 participants n=7 Participants	11 participants n=5 Participants	32 participants n=4 Participants
Region of Enrollment Poland	19 participants n=5 Participants	20 participants n=7 Participants	15 participants n=5 Participants	54 participants n=4 Participants
Region of Enrollment United Kingdom	1 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants	4 participants n=4 Participants
Region of Enrollment Australia	5 participants n=5 Participants	5 participants n=7 Participants	4 participants n=5 Participants	14 participants n=4 Participants
Region of Enrollment France	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants	8 participants n=4 Participants
Region of Enrollment Germany	5 participants n=5 Participants	4 participants n=7 Participants	2 participants n=5 Participants	11 participants n=4 Participants
Investigator's Global Assessment Clear	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Investigator's Global Assessment Almost Clear	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Investigator's Global Assessment Mild	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Investigator's Global Assessment Moderate	52 Participants n=5 Participants	55 Participants n=7 Participants	54 Participants n=5 Participants	161 Participants n=4 Participants
Investigator's Global Assessment Severe	48 Participants n=5 Participants	44 Participants n=7 Participants	45 Participants n=5 Participants	137 Participants n=4 Participants
Investigator's Global Assessment Missing	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Eczema Area and Severity Index	31.90 units on a scale STANDARD_DEVIATION 13.74 • n=5 Participants	31.89 units on a scale STANDARD_DEVIATION 12.97 • n=7 Participants	31.25 units on a scale STANDARD_DEVIATION 14.19 • n=5 Participants	31.68 units on a scale STANDARD_DEVIATION 13.60 • n=4 Participants
Scoring Atopic Dermatitis	68.41 units on a scale STANDARD_DEVIATION 13.51 • n=5 Participants	67.42 units on a scale STANDARD_DEVIATION 14.51 • n=7 Participants	67.70 units on a scale STANDARD_DEVIATION 14.77 • n=5 Participants	67.84 units on a scale STANDARD_DEVIATION 14.23 • n=4 Participants
Children's Dermatology Life Quality Index	13.29 units on a scale STANDARD_DEVIATION 7.18 • n=5 Participants	12.86 units on a scale STANDARD_DEVIATION 6.27 • n=7 Participants	13.14 units on a scale STANDARD_DEVIATION 5.99 • n=5 Participants	13.10 units on a scale STANDARD_DEVIATION 6.48 • n=4 Participants
Adolescent Worst Pruritus NRS (weekly average)	7.79 units on a scale STANDARD_DEVIATION 1.53 • n=5 Participants	7.49 units on a scale STANDARD_DEVIATION 1.58 • n=7 Participants	7.45 units on a scale STANDARD_DEVIATION 1.62 • n=5 Participants	7.58 units on a scale STANDARD_DEVIATION 1.58 • n=4 Participants
Body surface area affected by atopic dermatitis (AD)	49.8 percentage affected STANDARD_DEVIATION 23.0 • n=5 Participants	52.0 percentage affected STANDARD_DEVIATION 22.5 • n=7 Participants	50.9 percentage affected STANDARD_DEVIATION 23.5 • n=5 Participants	50.9 percentage affected STANDARD_DEVIATION 23.0 • n=4 Participants
Age of onset of atopic dermatitis (AD)	2.5 years STANDARD_DEVIATION 3.5 • n=5 Participants	2.1 years STANDARD_DEVIATION 3.3 • n=7 Participants	2.4 years STANDARD_DEVIATION 3.5 • n=5 Participants	2.4 years STANDARD_DEVIATION 3.4 • n=4 Participants
Duration of atopic dermatitis (AD)	12.1 years STANDARD_DEVIATION 3.7 • n=5 Participants	12.7 years STANDARD_DEVIATION 3.7 • n=7 Participants	12.0 years STANDARD_DEVIATION 3.4 • n=5 Participants	12.3 years STANDARD_DEVIATION 3.6 • n=4 Participants

PRIMARY outcome

Timeframe: At Week 16

Population: The full analysis set (FAS: All subjects randomised to initial treatment who were exposed to IMP and not randomised at the investigational sites where substantial quality/GCP issues were identified) was used for the primary analysis.

The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).

Outcome measures

Outcome measures
Measure	Initial Treatment Period - Tralokinumab 300 mg Q2W n=97 Participants Week 0 to Week 16: Tralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.	Initial Treatment Period - Tralokinumab 150 mg Q2W n=98 Participants Week 0 to Week 16: Tralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.	Initial Treatment Period - Placebo n=94 Participants Week 0 to Week 16: Placebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.	Maintenance Treatment Period - Tralokinumab 150 mg Q4W Week 16 to Week 52: Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 from Week 2 to Week 16 and initially randomised to tralokinumab 150 mg Q2W, re-randomised to tralokinumab 150 mg Q4W maintenance dosing regimen. At each visit (Q2W), subject received alternating dose administrations: 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab; or 2 subcutaneous injections (each 1.0 mL) of placebo.	Open-label Treatment -Tralokinumab 300 mg Q2W + Optional TCS Week 16 to Week 52: Subjects receiving initial treatment with tralokinumab 150 mg/tralokinumab 300 mg/placebo Q2W who did not achieve clinical response at Week 16 without use of rescue medication from Week 2 to Week 16, assigned to open-label treatment at Week 16 with tralokinumab 300 mg Q2W regimen + optional topical corticosteroids (TCS) OR Subjects receiving maintenance treatment with tralokinumab 150 mg Q2W/Q4W, tralokinumab 300 mg Q2W/Q4W, or placebo Q2W assigned to open-label treatment after Week 16 with tralokinumab 300 mg Q2W regimen + optional TCS if * IGA of at least 2 and not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA=0 at Week 16. * IGA of at least 3 and not achieving EASI75 over at least a 4-week period (i.e. over 3 consecutive visits) for subjects with IGA=1 at Week 16. * Not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA\>1 at Week 16. At each visit, subjects received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg.
Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16	17 Participants	21 Participants	4 Participants	—	—

PRIMARY outcome

Timeframe: At Week 16

The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.

Outcome measures

Outcome measures
Measure	Initial Treatment Period - Tralokinumab 300 mg Q2W n=97 Participants Week 0 to Week 16: Tralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.	Initial Treatment Period - Tralokinumab 150 mg Q2W n=98 Participants Week 0 to Week 16: Tralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.	Initial Treatment Period - Placebo n=94 Participants Week 0 to Week 16: Placebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.	Maintenance Treatment Period - Tralokinumab 150 mg Q4W Week 16 to Week 52: Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 from Week 2 to Week 16 and initially randomised to tralokinumab 150 mg Q2W, re-randomised to tralokinumab 150 mg Q4W maintenance dosing regimen. At each visit (Q2W), subject received alternating dose administrations: 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab; or 2 subcutaneous injections (each 1.0 mL) of placebo.	Open-label Treatment -Tralokinumab 300 mg Q2W + Optional TCS Week 16 to Week 52: Subjects receiving initial treatment with tralokinumab 150 mg/tralokinumab 300 mg/placebo Q2W who did not achieve clinical response at Week 16 without use of rescue medication from Week 2 to Week 16, assigned to open-label treatment at Week 16 with tralokinumab 300 mg Q2W regimen + optional topical corticosteroids (TCS) OR Subjects receiving maintenance treatment with tralokinumab 150 mg Q2W/Q4W, tralokinumab 300 mg Q2W/Q4W, or placebo Q2W assigned to open-label treatment after Week 16 with tralokinumab 300 mg Q2W regimen + optional TCS if * IGA of at least 2 and not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA=0 at Week 16. * IGA of at least 3 and not achieving EASI75 over at least a 4-week period (i.e. over 3 consecutive visits) for subjects with IGA=1 at Week 16. * Not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA\>1 at Week 16. At each visit, subjects received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg.
Subjects With at Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16	27 Participants	28 Participants	6 Participants	—	—

SECONDARY outcome

Timeframe: At Week 16

Population: Subjects in the full analysis set with baseline Adolescent Worst Pruritus weekly average ≥4. The full analysis set (FAS) comprised all subjects randomised to initial treatment who were exposed to IMP and not randomised at the investigational sites where substantial quality/GCP issues were identified.

The Adolescent Worst Pruritus NRS is used by subjects to assess their worst itch over the past 24 hours using an 11-point NRS with 0 indicating 'no itch' and 10 indicating 'worst itch possible'.

Outcome measures

Outcome measures
Measure	Initial Treatment Period - Tralokinumab 300 mg Q2W n=96 Participants Week 0 to Week 16: Tralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.	Initial Treatment Period - Tralokinumab 150 mg Q2W n=95 Participants Week 0 to Week 16: Tralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.	Initial Treatment Period - Placebo n=90 Participants Week 0 to Week 16: Placebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.	Maintenance Treatment Period - Tralokinumab 150 mg Q4W Week 16 to Week 52: Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 from Week 2 to Week 16 and initially randomised to tralokinumab 150 mg Q2W, re-randomised to tralokinumab 150 mg Q4W maintenance dosing regimen. At each visit (Q2W), subject received alternating dose administrations: 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab; or 2 subcutaneous injections (each 1.0 mL) of placebo.	Open-label Treatment -Tralokinumab 300 mg Q2W + Optional TCS Week 16 to Week 52: Subjects receiving initial treatment with tralokinumab 150 mg/tralokinumab 300 mg/placebo Q2W who did not achieve clinical response at Week 16 without use of rescue medication from Week 2 to Week 16, assigned to open-label treatment at Week 16 with tralokinumab 300 mg Q2W regimen + optional topical corticosteroids (TCS) OR Subjects receiving maintenance treatment with tralokinumab 150 mg Q2W/Q4W, tralokinumab 300 mg Q2W/Q4W, or placebo Q2W assigned to open-label treatment after Week 16 with tralokinumab 300 mg Q2W regimen + optional TCS if * IGA of at least 2 and not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA=0 at Week 16. * IGA of at least 3 and not achieving EASI75 over at least a 4-week period (i.e. over 3 consecutive visits) for subjects with IGA=1 at Week 16. * Not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA\>1 at Week 16. At each visit, subjects received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg.
Subjects With Reduction of Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Baseline to Week 16	24 Participants	22 Participants	3 Participants	—	—

SECONDARY outcome

Timeframe: From Week 0 to Week 16

The SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.

Outcome measures

Outcome measures
Measure	Initial Treatment Period - Tralokinumab 300 mg Q2W n=97 Participants Week 0 to Week 16: Tralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.	Initial Treatment Period - Tralokinumab 150 mg Q2W n=98 Participants Week 0 to Week 16: Tralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.	Initial Treatment Period - Placebo n=94 Participants Week 0 to Week 16: Placebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.	Maintenance Treatment Period - Tralokinumab 150 mg Q4W Week 16 to Week 52: Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 from Week 2 to Week 16 and initially randomised to tralokinumab 150 mg Q2W, re-randomised to tralokinumab 150 mg Q4W maintenance dosing regimen. At each visit (Q2W), subject received alternating dose administrations: 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab; or 2 subcutaneous injections (each 1.0 mL) of placebo.	Open-label Treatment -Tralokinumab 300 mg Q2W + Optional TCS Week 16 to Week 52: Subjects receiving initial treatment with tralokinumab 150 mg/tralokinumab 300 mg/placebo Q2W who did not achieve clinical response at Week 16 without use of rescue medication from Week 2 to Week 16, assigned to open-label treatment at Week 16 with tralokinumab 300 mg Q2W regimen + optional topical corticosteroids (TCS) OR Subjects receiving maintenance treatment with tralokinumab 150 mg Q2W/Q4W, tralokinumab 300 mg Q2W/Q4W, or placebo Q2W assigned to open-label treatment after Week 16 with tralokinumab 300 mg Q2W regimen + optional TCS if * IGA of at least 2 and not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA=0 at Week 16. * IGA of at least 3 and not achieving EASI75 over at least a 4-week period (i.e. over 3 consecutive visits) for subjects with IGA=1 at Week 16. * Not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA\>1 at Week 16. At each visit, subjects received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg.
Change in Scoring Atopic Dermatitis (SCORAD) From Baseline to Week 16	-29.1 units on a scale Standard Error 2.4	-27.5 units on a scale Standard Error 2.4	-9.5 units on a scale Standard Error 3.0	—	—

SECONDARY outcome

Timeframe: From Week 0 to Week 16

Population: Subjects in the full analysis set with non-missing baseline CDLQI score. The full analysis set (FAS) comprised all subjects randomised to initial treatment who were exposed to IMP and not randomised at the investigational sites where substantial quality/GCP issues were identified.

The CDLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on various aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all'; 1 = 'only a little'; 2 = 'quite a lot'; 3 = 'very much'). Item 7 (on school time) has one additional response category 'prevented school', which is also scored '3'. The total score of the CDLQI is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life.

Outcome measures

Outcome measures
Measure	Initial Treatment Period - Tralokinumab 300 mg Q2W n=94 Participants Week 0 to Week 16: Tralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.	Initial Treatment Period - Tralokinumab 150 mg Q2W n=95 Participants Week 0 to Week 16: Tralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.	Initial Treatment Period - Placebo n=89 Participants Week 0 to Week 16: Placebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.	Maintenance Treatment Period - Tralokinumab 150 mg Q4W Week 16 to Week 52: Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 from Week 2 to Week 16 and initially randomised to tralokinumab 150 mg Q2W, re-randomised to tralokinumab 150 mg Q4W maintenance dosing regimen. At each visit (Q2W), subject received alternating dose administrations: 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab; or 2 subcutaneous injections (each 1.0 mL) of placebo.	Open-label Treatment -Tralokinumab 300 mg Q2W + Optional TCS Week 16 to Week 52: Subjects receiving initial treatment with tralokinumab 150 mg/tralokinumab 300 mg/placebo Q2W who did not achieve clinical response at Week 16 without use of rescue medication from Week 2 to Week 16, assigned to open-label treatment at Week 16 with tralokinumab 300 mg Q2W regimen + optional topical corticosteroids (TCS) OR Subjects receiving maintenance treatment with tralokinumab 150 mg Q2W/Q4W, tralokinumab 300 mg Q2W/Q4W, or placebo Q2W assigned to open-label treatment after Week 16 with tralokinumab 300 mg Q2W regimen + optional TCS if * IGA of at least 2 and not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA=0 at Week 16. * IGA of at least 3 and not achieving EASI75 over at least a 4-week period (i.e. over 3 consecutive visits) for subjects with IGA=1 at Week 16. * Not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA\>1 at Week 16. At each visit, subjects received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg.
Change in Children's Dermatology Life Quality Index (CDLQI) Score From Baseline to Week 16	-6.7 units on a scale Standard Error 0.6	-6.1 units on a scale Standard Error 0.6	-4.1 units on a scale Standard Error 0.7	—	—

SECONDARY outcome

Timeframe: From Week 0 to Week 16

Population: The analysis was performed on the safety analysis set. The safety analysis set comprised all subjects randomised to initial treatment and exposed to IMP, except for subjects randomised at the investigational sites where substantial quality/GCP issues were identified . The safety analysis set was identical to the full analysis set.

Number of AEs during the Initial treatment period is presented. For a summary of AEs and SAEs by MedDRA system organ class (SOC) and preferred term (PT) during the initial treatment period, maintenance treatment period, open-label treatment period, and safety follow-up period, see the Adverse Events Overview section.

Outcome measures

Outcome measures
Measure	Initial Treatment Period - Tralokinumab 300 mg Q2W n=97 Participants Week 0 to Week 16: Tralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.	Initial Treatment Period - Tralokinumab 150 mg Q2W n=98 Participants Week 0 to Week 16: Tralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.	Initial Treatment Period - Placebo n=94 Participants Week 0 to Week 16: Placebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.	Maintenance Treatment Period - Tralokinumab 150 mg Q4W Week 16 to Week 52: Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 from Week 2 to Week 16 and initially randomised to tralokinumab 150 mg Q2W, re-randomised to tralokinumab 150 mg Q4W maintenance dosing regimen. At each visit (Q2W), subject received alternating dose administrations: 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab; or 2 subcutaneous injections (each 1.0 mL) of placebo.	Open-label Treatment -Tralokinumab 300 mg Q2W + Optional TCS Week 16 to Week 52: Subjects receiving initial treatment with tralokinumab 150 mg/tralokinumab 300 mg/placebo Q2W who did not achieve clinical response at Week 16 without use of rescue medication from Week 2 to Week 16, assigned to open-label treatment at Week 16 with tralokinumab 300 mg Q2W regimen + optional topical corticosteroids (TCS) OR Subjects receiving maintenance treatment with tralokinumab 150 mg Q2W/Q4W, tralokinumab 300 mg Q2W/Q4W, or placebo Q2W assigned to open-label treatment after Week 16 with tralokinumab 300 mg Q2W regimen + optional TCS if * IGA of at least 2 and not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA=0 at Week 16. * IGA of at least 3 and not achieving EASI75 over at least a 4-week period (i.e. over 3 consecutive visits) for subjects with IGA=1 at Week 16. * Not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA\>1 at Week 16. At each visit, subjects received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg.
Number of Adverse Events	130 number of adverse events	175 number of adverse events	134 number of adverse events	—	—

SECONDARY outcome

Timeframe: From Week 0 to Week 16

Population: The analysis was performed on the safety analysis set. The safety analysis set comprised all subjects randomised to initial treatment, except for subjects randomised at the investigational sites where substantial quality/GCP issues were identified and subjects for whom no post-baseline safety data were available. The safety analysis set was identical to the full analysis set.

Anti-tralokinumab antibody levels were analysed using a validated bioanalytical method.

Outcome measures

Outcome measures
Measure	Initial Treatment Period - Tralokinumab 300 mg Q2W n=97 Participants Week 0 to Week 16: Tralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.	Initial Treatment Period - Tralokinumab 150 mg Q2W n=98 Participants Week 0 to Week 16: Tralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.	Initial Treatment Period - Placebo n=94 Participants Week 0 to Week 16: Placebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.	Maintenance Treatment Period - Tralokinumab 150 mg Q4W Week 16 to Week 52: Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 from Week 2 to Week 16 and initially randomised to tralokinumab 150 mg Q2W, re-randomised to tralokinumab 150 mg Q4W maintenance dosing regimen. At each visit (Q2W), subject received alternating dose administrations: 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab; or 2 subcutaneous injections (each 1.0 mL) of placebo.	Open-label Treatment -Tralokinumab 300 mg Q2W + Optional TCS Week 16 to Week 52: Subjects receiving initial treatment with tralokinumab 150 mg/tralokinumab 300 mg/placebo Q2W who did not achieve clinical response at Week 16 without use of rescue medication from Week 2 to Week 16, assigned to open-label treatment at Week 16 with tralokinumab 300 mg Q2W regimen + optional topical corticosteroids (TCS) OR Subjects receiving maintenance treatment with tralokinumab 150 mg Q2W/Q4W, tralokinumab 300 mg Q2W/Q4W, or placebo Q2W assigned to open-label treatment after Week 16 with tralokinumab 300 mg Q2W regimen + optional TCS if * IGA of at least 2 and not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA=0 at Week 16. * IGA of at least 3 and not achieving EASI75 over at least a 4-week period (i.e. over 3 consecutive visits) for subjects with IGA=1 at Week 16. * Not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA\>1 at Week 16. At each visit, subjects received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg.
Presence of Anti-drug Antibodies	1 Participants	7 Participants	2 Participants	—	—

SECONDARY outcome

Timeframe: At Week 16

Outcome measures

Outcome measures
Measure	Initial Treatment Period - Tralokinumab 300 mg Q2W n=97 Participants Week 0 to Week 16: Tralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.	Initial Treatment Period - Tralokinumab 150 mg Q2W n=98 Participants Week 0 to Week 16: Tralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.	Initial Treatment Period - Placebo n=94 Participants Week 0 to Week 16: Placebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.	Maintenance Treatment Period - Tralokinumab 150 mg Q4W Week 16 to Week 52: Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 from Week 2 to Week 16 and initially randomised to tralokinumab 150 mg Q2W, re-randomised to tralokinumab 150 mg Q4W maintenance dosing regimen. At each visit (Q2W), subject received alternating dose administrations: 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab; or 2 subcutaneous injections (each 1.0 mL) of placebo.	Open-label Treatment -Tralokinumab 300 mg Q2W + Optional TCS Week 16 to Week 52: Subjects receiving initial treatment with tralokinumab 150 mg/tralokinumab 300 mg/placebo Q2W who did not achieve clinical response at Week 16 without use of rescue medication from Week 2 to Week 16, assigned to open-label treatment at Week 16 with tralokinumab 300 mg Q2W regimen + optional topical corticosteroids (TCS) OR Subjects receiving maintenance treatment with tralokinumab 150 mg Q2W/Q4W, tralokinumab 300 mg Q2W/Q4W, or placebo Q2W assigned to open-label treatment after Week 16 with tralokinumab 300 mg Q2W regimen + optional TCS if * IGA of at least 2 and not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA=0 at Week 16. * IGA of at least 3 and not achieving EASI75 over at least a 4-week period (i.e. over 3 consecutive visits) for subjects with IGA=1 at Week 16. * Not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA\>1 at Week 16. At each visit, subjects received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg.
Subjects With at Least 50% Reduction in Eczema Area and Severity Index (EASI50) at Week 16.	50 Participants	45 Participants	13 Participants	—	—

SECONDARY outcome

Timeframe: At Week 16

Outcome measures

Outcome measures
Measure	Initial Treatment Period - Tralokinumab 300 mg Q2W n=97 Participants Week 0 to Week 16: Tralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.	Initial Treatment Period - Tralokinumab 150 mg Q2W n=98 Participants Week 0 to Week 16: Tralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.	Initial Treatment Period - Placebo n=94 Participants Week 0 to Week 16: Placebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.	Maintenance Treatment Period - Tralokinumab 150 mg Q4W Week 16 to Week 52: Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 from Week 2 to Week 16 and initially randomised to tralokinumab 150 mg Q2W, re-randomised to tralokinumab 150 mg Q4W maintenance dosing regimen. At each visit (Q2W), subject received alternating dose administrations: 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab; or 2 subcutaneous injections (each 1.0 mL) of placebo.	Open-label Treatment -Tralokinumab 300 mg Q2W + Optional TCS Week 16 to Week 52: Subjects receiving initial treatment with tralokinumab 150 mg/tralokinumab 300 mg/placebo Q2W who did not achieve clinical response at Week 16 without use of rescue medication from Week 2 to Week 16, assigned to open-label treatment at Week 16 with tralokinumab 300 mg Q2W regimen + optional topical corticosteroids (TCS) OR Subjects receiving maintenance treatment with tralokinumab 150 mg Q2W/Q4W, tralokinumab 300 mg Q2W/Q4W, or placebo Q2W assigned to open-label treatment after Week 16 with tralokinumab 300 mg Q2W regimen + optional TCS if * IGA of at least 2 and not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA=0 at Week 16. * IGA of at least 3 and not achieving EASI75 over at least a 4-week period (i.e. over 3 consecutive visits) for subjects with IGA=1 at Week 16. * Not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA\>1 at Week 16. At each visit, subjects received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg.
Subjects With at Least 90% Reduction in Eczema Area and Severity Index (EASI90) at Week 16.	17 Participants	19 Participants	4 Participants	—	—

SECONDARY outcome

Timeframe: From Week 0 to Week 16

Outcome measures

Outcome measures
Measure	Initial Treatment Period - Tralokinumab 300 mg Q2W n=97 Participants Week 0 to Week 16: Tralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.	Initial Treatment Period - Tralokinumab 150 mg Q2W n=98 Participants Week 0 to Week 16: Tralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.	Initial Treatment Period - Placebo n=94 Participants Week 0 to Week 16: Placebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.	Maintenance Treatment Period - Tralokinumab 150 mg Q4W Week 16 to Week 52: Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 from Week 2 to Week 16 and initially randomised to tralokinumab 150 mg Q2W, re-randomised to tralokinumab 150 mg Q4W maintenance dosing regimen. At each visit (Q2W), subject received alternating dose administrations: 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab; or 2 subcutaneous injections (each 1.0 mL) of placebo.	Open-label Treatment -Tralokinumab 300 mg Q2W + Optional TCS Week 16 to Week 52: Subjects receiving initial treatment with tralokinumab 150 mg/tralokinumab 300 mg/placebo Q2W who did not achieve clinical response at Week 16 without use of rescue medication from Week 2 to Week 16, assigned to open-label treatment at Week 16 with tralokinumab 300 mg Q2W regimen + optional topical corticosteroids (TCS) OR Subjects receiving maintenance treatment with tralokinumab 150 mg Q2W/Q4W, tralokinumab 300 mg Q2W/Q4W, or placebo Q2W assigned to open-label treatment after Week 16 with tralokinumab 300 mg Q2W regimen + optional TCS if * IGA of at least 2 and not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA=0 at Week 16. * IGA of at least 3 and not achieving EASI75 over at least a 4-week period (i.e. over 3 consecutive visits) for subjects with IGA=1 at Week 16. * Not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA\>1 at Week 16. At each visit, subjects received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg.
Change in Eczema Area and Severity Index (EASI) Score From Baseline to Week 16	-18.1 units on a scale Standard Error 1.3	-18.1 units on a scale Standard Error 1.4	-8.7 units on a scale Standard Error 1.6	—	—

SECONDARY outcome

Timeframe: At Week 16

The SCORAD is a validated tool to evaluate the extent and severity of atopic dermatitis lesions, along with subjective symptoms. The score ranges from 0 to 103, with a higher values indicating a more extensive and/or severe condition.

Outcome measures

Outcome measures
Measure	Initial Treatment Period - Tralokinumab 300 mg Q2W n=97 Participants Week 0 to Week 16: Tralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.	Initial Treatment Period - Tralokinumab 150 mg Q2W n=98 Participants Week 0 to Week 16: Tralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.	Initial Treatment Period - Placebo n=94 Participants Week 0 to Week 16: Placebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.	Maintenance Treatment Period - Tralokinumab 150 mg Q4W Week 16 to Week 52: Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 from Week 2 to Week 16 and initially randomised to tralokinumab 150 mg Q2W, re-randomised to tralokinumab 150 mg Q4W maintenance dosing regimen. At each visit (Q2W), subject received alternating dose administrations: 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab; or 2 subcutaneous injections (each 1.0 mL) of placebo.	Open-label Treatment -Tralokinumab 300 mg Q2W + Optional TCS Week 16 to Week 52: Subjects receiving initial treatment with tralokinumab 150 mg/tralokinumab 300 mg/placebo Q2W who did not achieve clinical response at Week 16 without use of rescue medication from Week 2 to Week 16, assigned to open-label treatment at Week 16 with tralokinumab 300 mg Q2W regimen + optional topical corticosteroids (TCS) OR Subjects receiving maintenance treatment with tralokinumab 150 mg Q2W/Q4W, tralokinumab 300 mg Q2W/Q4W, or placebo Q2W assigned to open-label treatment after Week 16 with tralokinumab 300 mg Q2W regimen + optional TCS if * IGA of at least 2 and not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA=0 at Week 16. * IGA of at least 3 and not achieving EASI75 over at least a 4-week period (i.e. over 3 consecutive visits) for subjects with IGA=1 at Week 16. * Not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA\>1 at Week 16. At each visit, subjects received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg.
Subjects With at Least 75% Reduction in Scoring Atopic Dermatitis (SCORAD75) at Week 16	12 Participants	16 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: At Week 16

Outcome measures

Outcome measures
Measure	Initial Treatment Period - Tralokinumab 300 mg Q2W n=97 Participants Week 0 to Week 16: Tralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.	Initial Treatment Period - Tralokinumab 150 mg Q2W n=98 Participants Week 0 to Week 16: Tralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.	Initial Treatment Period - Placebo n=94 Participants Week 0 to Week 16: Placebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.	Maintenance Treatment Period - Tralokinumab 150 mg Q4W Week 16 to Week 52: Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 from Week 2 to Week 16 and initially randomised to tralokinumab 150 mg Q2W, re-randomised to tralokinumab 150 mg Q4W maintenance dosing regimen. At each visit (Q2W), subject received alternating dose administrations: 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab; or 2 subcutaneous injections (each 1.0 mL) of placebo.	Open-label Treatment -Tralokinumab 300 mg Q2W + Optional TCS Week 16 to Week 52: Subjects receiving initial treatment with tralokinumab 150 mg/tralokinumab 300 mg/placebo Q2W who did not achieve clinical response at Week 16 without use of rescue medication from Week 2 to Week 16, assigned to open-label treatment at Week 16 with tralokinumab 300 mg Q2W regimen + optional topical corticosteroids (TCS) OR Subjects receiving maintenance treatment with tralokinumab 150 mg Q2W/Q4W, tralokinumab 300 mg Q2W/Q4W, or placebo Q2W assigned to open-label treatment after Week 16 with tralokinumab 300 mg Q2W regimen + optional TCS if * IGA of at least 2 and not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA=0 at Week 16. * IGA of at least 3 and not achieving EASI75 over at least a 4-week period (i.e. over 3 consecutive visits) for subjects with IGA=1 at Week 16. * Not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA\>1 at Week 16. At each visit, subjects received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg.
Subjects With at Least 50% Reduction in Scoring Atopic Dermatitis (SCORAD50) at Week 16	30 Participants	30 Participants	5 Participants	—	—

SECONDARY outcome

Timeframe: From Week 0 to Week 16

Population: Subjects in the full analysis set with non-missing baseline Adolescent Worst Pruritus NRS score. The full analysis set (FAS) comprised all subjects randomised to initial treatment who were exposed to IMP and not randomised at the investigational sites where substantial quality/GCP issues were identified.

The Adolescent Worst Pruritus NRS is used by subjects to assess their worst itch over the past 24 hours using an 11-point NRS with 0 indicating 'no itch' and 10 indicating 'worst itch possible'.

Outcome measures

Outcome measures
Measure	Initial Treatment Period - Tralokinumab 300 mg Q2W n=96 Participants Week 0 to Week 16: Tralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.	Initial Treatment Period - Tralokinumab 150 mg Q2W n=96 Participants Week 0 to Week 16: Tralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.	Initial Treatment Period - Placebo n=92 Participants Week 0 to Week 16: Placebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.	Maintenance Treatment Period - Tralokinumab 150 mg Q4W Week 16 to Week 52: Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 from Week 2 to Week 16 and initially randomised to tralokinumab 150 mg Q2W, re-randomised to tralokinumab 150 mg Q4W maintenance dosing regimen. At each visit (Q2W), subject received alternating dose administrations: 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab; or 2 subcutaneous injections (each 1.0 mL) of placebo.	Open-label Treatment -Tralokinumab 300 mg Q2W + Optional TCS Week 16 to Week 52: Subjects receiving initial treatment with tralokinumab 150 mg/tralokinumab 300 mg/placebo Q2W who did not achieve clinical response at Week 16 without use of rescue medication from Week 2 to Week 16, assigned to open-label treatment at Week 16 with tralokinumab 300 mg Q2W regimen + optional topical corticosteroids (TCS) OR Subjects receiving maintenance treatment with tralokinumab 150 mg Q2W/Q4W, tralokinumab 300 mg Q2W/Q4W, or placebo Q2W assigned to open-label treatment after Week 16 with tralokinumab 300 mg Q2W regimen + optional TCS if * IGA of at least 2 and not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA=0 at Week 16. * IGA of at least 3 and not achieving EASI75 over at least a 4-week period (i.e. over 3 consecutive visits) for subjects with IGA=1 at Week 16. * Not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA\>1 at Week 16. At each visit, subjects received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg.
Change in Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) From Baseline to Week 16	-3.0 units on a scale Standard Error 0.3	-2.7 units on a scale Standard Error 0.3	-1.5 units on a scale Standard Error 0.3	—	—

SECONDARY outcome

Timeframe: At Week 16

Population: Subjects in the full analysis set with baseline Adolescent Worst Pruritus weekly average ≥3. The full analysis set (FAS) comprised all subjects randomised to initial treatment who were exposed to IMP and not randomised at the investigational sites where substantial quality/GCP issues were identified.

The Adolescent Worst Pruritus NRS is used by subjects to assess their worst itch over the past 24 hours using an 11-point NRS with 0 indicating 'no itch' and 10 indicating 'worst itch possible'.

Outcome measures

Outcome measures
Measure	Initial Treatment Period - Tralokinumab 300 mg Q2W n=96 Participants Week 0 to Week 16: Tralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.	Initial Treatment Period - Tralokinumab 150 mg Q2W n=95 Participants Week 0 to Week 16: Tralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.	Initial Treatment Period - Placebo n=91 Participants Week 0 to Week 16: Placebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.	Maintenance Treatment Period - Tralokinumab 150 mg Q4W Week 16 to Week 52: Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 from Week 2 to Week 16 and initially randomised to tralokinumab 150 mg Q2W, re-randomised to tralokinumab 150 mg Q4W maintenance dosing regimen. At each visit (Q2W), subject received alternating dose administrations: 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab; or 2 subcutaneous injections (each 1.0 mL) of placebo.	Open-label Treatment -Tralokinumab 300 mg Q2W + Optional TCS Week 16 to Week 52: Subjects receiving initial treatment with tralokinumab 150 mg/tralokinumab 300 mg/placebo Q2W who did not achieve clinical response at Week 16 without use of rescue medication from Week 2 to Week 16, assigned to open-label treatment at Week 16 with tralokinumab 300 mg Q2W regimen + optional topical corticosteroids (TCS) OR Subjects receiving maintenance treatment with tralokinumab 150 mg Q2W/Q4W, tralokinumab 300 mg Q2W/Q4W, or placebo Q2W assigned to open-label treatment after Week 16 with tralokinumab 300 mg Q2W regimen + optional TCS if * IGA of at least 2 and not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA=0 at Week 16. * IGA of at least 3 and not achieving EASI75 over at least a 4-week period (i.e. over 3 consecutive visits) for subjects with IGA=1 at Week 16. * Not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA\>1 at Week 16. At each visit, subjects received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg.
Participants With Reduction of Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 3 From Baseline to Week 16	28 Participants	29 Participants	8 Participants	—	—

SECONDARY outcome

Timeframe: From Week 0 to Week 16

Population: Subjects in the full analysis set with non-missing baseline POEM score. The full analysis set (FAS) comprised all subjects randomised to initial treatment who were exposed to IMP and not randomised at the investigational sites where substantial quality/GCP issues were identified.

The POEM is a validated questionnaire used to assess disease symptoms in atopic eczema patients in both clinical practice and clinical trials. The tool consists of 7 items each addressing a specific symptom (itching, sleep, bleeding, weeping, cracking, flaking, and dryness). Subjects will score how often they have experienced each symptom over the previous week on a 5-point categorical response scale (0 = 'no days'; 1 = '1 to 2 days'; 2 = '3 to 4 days'; 3 = '5 to 6' days; 4 = 'every day'). The total score is the sum of the 7 items (range 0 to 28) and reflects disease-related morbidity; a high score is indicative of a worse disease severity.

Outcome measures

Outcome measures
Measure	Initial Treatment Period - Tralokinumab 300 mg Q2W n=94 Participants Week 0 to Week 16: Tralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.	Initial Treatment Period - Tralokinumab 150 mg Q2W n=95 Participants Week 0 to Week 16: Tralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.	Initial Treatment Period - Placebo n=87 Participants Week 0 to Week 16: Placebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.	Maintenance Treatment Period - Tralokinumab 150 mg Q4W Week 16 to Week 52: Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 from Week 2 to Week 16 and initially randomised to tralokinumab 150 mg Q2W, re-randomised to tralokinumab 150 mg Q4W maintenance dosing regimen. At each visit (Q2W), subject received alternating dose administrations: 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab; or 2 subcutaneous injections (each 1.0 mL) of placebo.	Open-label Treatment -Tralokinumab 300 mg Q2W + Optional TCS Week 16 to Week 52: Subjects receiving initial treatment with tralokinumab 150 mg/tralokinumab 300 mg/placebo Q2W who did not achieve clinical response at Week 16 without use of rescue medication from Week 2 to Week 16, assigned to open-label treatment at Week 16 with tralokinumab 300 mg Q2W regimen + optional topical corticosteroids (TCS) OR Subjects receiving maintenance treatment with tralokinumab 150 mg Q2W/Q4W, tralokinumab 300 mg Q2W/Q4W, or placebo Q2W assigned to open-label treatment after Week 16 with tralokinumab 300 mg Q2W regimen + optional TCS if * IGA of at least 2 and not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA=0 at Week 16. * IGA of at least 3 and not achieving EASI75 over at least a 4-week period (i.e. over 3 consecutive visits) for subjects with IGA=1 at Week 16. * Not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA\>1 at Week 16. At each visit, subjects received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg.
Change in Patient Oriented Eczema Measure (POEM) From Baseline to Week 16	-8.4 units on a scale Standard Error 0.8	-7.8 units on a scale Standard Error 0.8	-2.4 units on a scale Standard Error 1.0	—	—

SECONDARY outcome

Timeframe: At Week 16

Population: Subjects in the full analysis set who were randomised to tralokinumab. The full analysis set (FAS) comprised all subjects randomised to initial treatment who were exposed to IMP and not randomised at the investigational sites where substantial quality/GCP issues were identified.

Serum samples for determination of tralokinumab concentrations were analysed by a laboratory using a validated bioanalytical method.

Outcome measures

Outcome measures
Measure	Initial Treatment Period - Tralokinumab 300 mg Q2W n=97 Participants Week 0 to Week 16: Tralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.	Initial Treatment Period - Tralokinumab 150 mg Q2W n=98 Participants Week 0 to Week 16: Tralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.	Initial Treatment Period - Placebo Week 0 to Week 16: Placebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.	Maintenance Treatment Period - Tralokinumab 150 mg Q4W Week 16 to Week 52: Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 from Week 2 to Week 16 and initially randomised to tralokinumab 150 mg Q2W, re-randomised to tralokinumab 150 mg Q4W maintenance dosing regimen. At each visit (Q2W), subject received alternating dose administrations: 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab; or 2 subcutaneous injections (each 1.0 mL) of placebo.	Open-label Treatment -Tralokinumab 300 mg Q2W + Optional TCS Week 16 to Week 52: Subjects receiving initial treatment with tralokinumab 150 mg/tralokinumab 300 mg/placebo Q2W who did not achieve clinical response at Week 16 without use of rescue medication from Week 2 to Week 16, assigned to open-label treatment at Week 16 with tralokinumab 300 mg Q2W regimen + optional topical corticosteroids (TCS) OR Subjects receiving maintenance treatment with tralokinumab 150 mg Q2W/Q4W, tralokinumab 300 mg Q2W/Q4W, or placebo Q2W assigned to open-label treatment after Week 16 with tralokinumab 300 mg Q2W regimen + optional TCS if * IGA of at least 2 and not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA=0 at Week 16. * IGA of at least 3 and not achieving EASI75 over at least a 4-week period (i.e. over 3 consecutive visits) for subjects with IGA=1 at Week 16. * Not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA\>1 at Week 16. At each visit, subjects received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg.
Tralokinumab Serum Trough Concentration at Week 16	105.7 microgram/mL Geometric Coefficient of Variation 39.0	56.4 microgram/mL Geometric Coefficient of Variation 35.4	—	—	—

SECONDARY outcome

Timeframe: At Week 52

Population: Subjects in the full analysis set (FAS) who were re-randomised to maintenance treatment and achieved an Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16 without use of rescue medication from Week 2 to Week 16.

The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).

Outcome measures

Outcome measures
Measure	Initial Treatment Period - Tralokinumab 300 mg Q2W n=8 Participants Week 0 to Week 16: Tralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.	Initial Treatment Period - Tralokinumab 150 mg Q2W n=8 Participants Week 0 to Week 16: Tralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.	Initial Treatment Period - Placebo n=9 Participants Week 0 to Week 16: Placebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.	Maintenance Treatment Period - Tralokinumab 150 mg Q4W n=10 Participants Week 16 to Week 52: Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 from Week 2 to Week 16 and initially randomised to tralokinumab 150 mg Q2W, re-randomised to tralokinumab 150 mg Q4W maintenance dosing regimen. At each visit (Q2W), subject received alternating dose administrations: 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab; or 2 subcutaneous injections (each 1.0 mL) of placebo.	Open-label Treatment -Tralokinumab 300 mg Q2W + Optional TCS Week 16 to Week 52: Subjects receiving initial treatment with tralokinumab 150 mg/tralokinumab 300 mg/placebo Q2W who did not achieve clinical response at Week 16 without use of rescue medication from Week 2 to Week 16, assigned to open-label treatment at Week 16 with tralokinumab 300 mg Q2W regimen + optional topical corticosteroids (TCS) OR Subjects receiving maintenance treatment with tralokinumab 150 mg Q2W/Q4W, tralokinumab 300 mg Q2W/Q4W, or placebo Q2W assigned to open-label treatment after Week 16 with tralokinumab 300 mg Q2W regimen + optional TCS if * IGA of at least 2 and not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA=0 at Week 16. * IGA of at least 3 and not achieving EASI75 over at least a 4-week period (i.e. over 3 consecutive visits) for subjects with IGA=1 at Week 16. * Not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA\>1 at Week 16. At each visit, subjects received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg.
Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 52 Among Subjects With IGA Score of 0 or 1 at Week 16 After Initial Randomisation to Tralokinumab and Without Use of Rescue From Week 2 to Week 16	3 Participants	7 Participants	6 Participants	6 Participants	—

SECONDARY outcome

Timeframe: At Week 52

Population: Subjects in the full analysis set (FAS) who were re-randomised to maintenance treatment and achieved at Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16 without use of rescue medication from Week 2 to Week 16.

Outcome measures

Outcome measures
Measure	Initial Treatment Period - Tralokinumab 300 mg Q2W n=9 Participants Week 0 to Week 16: Tralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.	Initial Treatment Period - Tralokinumab 150 mg Q2W n=13 Participants Week 0 to Week 16: Tralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.	Initial Treatment Period - Placebo n=11 Participants Week 0 to Week 16: Placebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.	Maintenance Treatment Period - Tralokinumab 150 mg Q4W n=14 Participants Week 16 to Week 52: Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 from Week 2 to Week 16 and initially randomised to tralokinumab 150 mg Q2W, re-randomised to tralokinumab 150 mg Q4W maintenance dosing regimen. At each visit (Q2W), subject received alternating dose administrations: 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab; or 2 subcutaneous injections (each 1.0 mL) of placebo.	Open-label Treatment -Tralokinumab 300 mg Q2W + Optional TCS Week 16 to Week 52: Subjects receiving initial treatment with tralokinumab 150 mg/tralokinumab 300 mg/placebo Q2W who did not achieve clinical response at Week 16 without use of rescue medication from Week 2 to Week 16, assigned to open-label treatment at Week 16 with tralokinumab 300 mg Q2W regimen + optional topical corticosteroids (TCS) OR Subjects receiving maintenance treatment with tralokinumab 150 mg Q2W/Q4W, tralokinumab 300 mg Q2W/Q4W, or placebo Q2W assigned to open-label treatment after Week 16 with tralokinumab 300 mg Q2W regimen + optional TCS if * IGA of at least 2 and not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA=0 at Week 16. * IGA of at least 3 and not achieving EASI75 over at least a 4-week period (i.e. over 3 consecutive visits) for subjects with IGA=1 at Week 16. * Not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA\>1 at Week 16. At each visit, subjects received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg.
Subjects With at Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 52 Among Subjects With at Least 75% Reduction in EASI at Week 16 After Initial Randomisation to Tralokinumab and Without Use of Rescue From Week 2 to Week 16	4 Participants	7 Participants	7 Participants	7 Participants	—

SECONDARY outcome

Timeframe: At Week 66

Population: 13 subjects in maintenance safety analysis set who were initially randomised to tralokinumab and completed the maintenance treatment period on treatment. 234 subjects in the open-label safety analysis set.

Serum samples for determination of tralokinumab concentrations were analysed by a laboratory using a validated bioanalytical method.

Outcome measures

Outcome measures
Measure	Initial Treatment Period - Tralokinumab 300 mg Q2W n=1 Participants Week 0 to Week 16: Tralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.	Initial Treatment Period - Tralokinumab 150 mg Q2W n=5 Participants Week 0 to Week 16: Tralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.	Initial Treatment Period - Placebo n=4 Participants Week 0 to Week 16: Placebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.	Maintenance Treatment Period - Tralokinumab 150 mg Q4W n=3 Participants Week 16 to Week 52: Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 from Week 2 to Week 16 and initially randomised to tralokinumab 150 mg Q2W, re-randomised to tralokinumab 150 mg Q4W maintenance dosing regimen. At each visit (Q2W), subject received alternating dose administrations: 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab; or 2 subcutaneous injections (each 1.0 mL) of placebo.	Open-label Treatment -Tralokinumab 300 mg Q2W + Optional TCS n=234 Participants Week 16 to Week 52: Subjects receiving initial treatment with tralokinumab 150 mg/tralokinumab 300 mg/placebo Q2W who did not achieve clinical response at Week 16 without use of rescue medication from Week 2 to Week 16, assigned to open-label treatment at Week 16 with tralokinumab 300 mg Q2W regimen + optional topical corticosteroids (TCS) OR Subjects receiving maintenance treatment with tralokinumab 150 mg Q2W/Q4W, tralokinumab 300 mg Q2W/Q4W, or placebo Q2W assigned to open-label treatment after Week 16 with tralokinumab 300 mg Q2W regimen + optional TCS if * IGA of at least 2 and not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA=0 at Week 16. * IGA of at least 3 and not achieving EASI75 over at least a 4-week period (i.e. over 3 consecutive visits) for subjects with IGA=1 at Week 16. * Not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA\>1 at Week 16. At each visit, subjects received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg.
Tralokinumab Serum Trough Concentration at Week 66	5.9 microgram/mL Geometric Coefficient of Variation NA 1 subject provided data at Week 66, hence coefficient of variation could not be calculated.	1.0 microgram/mL Geometric Coefficient of Variation 458.0	1.5 microgram/mL Geometric Coefficient of Variation 168.6	2.6 microgram/mL Geometric Coefficient of Variation 75.6	4.4 microgram/mL Geometric Coefficient of Variation 136.5

Adverse Events

Initial Treatment Period - Tralokinumab 300 Q2W

Serious events: 1 serious events

Other events: 44 other events

Deaths: 0 deaths

Initial Treatment Period - Tralokinumab 150 Q2W

Serious events: 3 serious events

Other events: 47 other events

Deaths: 0 deaths

Initial Treatment Period - Placebo

Serious events: 5 serious events

Other events: 36 other events

Deaths: 0 deaths

Maintenance Treatment Period - Tralokinumab 300 Q2W

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Maintenance Treatment Period - Tralokinumab 300 Q4W

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Maintenance Treatment Period - Tralokinumab 150 Q2W

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Maintenance Treatment Period - Tralokinumab 150 Q4W

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Maintenance Treatment Period - Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Open-label Treatment - Tralokinumab 300 Q2W + Optional TCS

Serious events: 7 serious events

Other events: 100 other events

Deaths: 0 deaths

Safety Follow-up

Serious events: 3 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Initial Treatment Period - Tralokinumab 300 Q2W n=97 participants at risk Initial Treatment Period - Tralokinumab 300 Q2W (n=97, PYE=29.48)	Initial Treatment Period - Tralokinumab 150 Q2W n=98 participants at risk Initial Treatment Period - Tralokinumab 150 Q2W (n=98, PYE=29.33)	Initial Treatment Period - Placebo n=94 participants at risk Initial Treatment Period - Placebo (n=94, PYE=27.93)	Maintenance Treatment Period - Tralokinumab 300 Q2W n=11 participants at risk Maintenance Treatment Period - Tralokinumab 300 Q2W (n=11, PYE=5.61)	Maintenance Treatment Period - Tralokinumab 300 Q4W n=13 participants at risk Maintenance Treatment Period - Tralokinumab 300 Q4W (n=13, PYE=6.78)	Maintenance Treatment Period - Tralokinumab 150 Q2W n=12 participants at risk Maintenance Treatment Period - Tralokinumab 150 Q2W (n=12, PYE=6.40)	Maintenance Treatment Period - Tralokinumab 150 Q4W n=14 participants at risk Maintenance Treatment Period - Tralokinumab 150 Q4W (n=14, PYE=6.53)	Maintenance Treatment Period - Placebo n=6 participants at risk Maintenance Treatment Period - Placebo (n=6, PYE=2.98)	Open-label Treatment - Tralokinumab 300 Q2W + Optional TCS n=234 participants at risk Open-label Treatment - Tralokinumab 300 Q2W + optional TCS (n=234, PYE=151.12)	Safety Follow-up n=234 participants at risk Safety Follow-up (n=234, PYE=54.00)
Gastrointestinal disorders Gastritis	0.00% 0/97 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/98 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/94 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.43% 1/234 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Immune system disorders Anaphylactic reaction	0.00% 0/97 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/98 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	1.1% 1/94 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.43% 1/234 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.43% 1/234 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Infections and infestations Appendicitis perforated	0.00% 0/97 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/98 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/94 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.43% 1/234 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Infections and infestations Cellulitis	0.00% 0/97 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	1.0% 1/98 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/94 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Infections and infestations Infectious mononucleosis	0.00% 0/97 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/98 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	1.1% 1/94 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Injury, poisoning and procedural complications Concussion	0.00% 0/97 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/98 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/94 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.43% 1/234 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Injury, poisoning and procedural complications Intentional overdose	0.00% 0/97 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/98 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/94 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.43% 1/234 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Injury, poisoning and procedural complications Radius fracture	1.0% 1/97 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/98 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/94 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Nervous system disorders Cerebrovascular accident	0.00% 0/97 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	1.0% 1/98 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/94 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Psychiatric disorders Anorexia nervosa	0.00% 0/97 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/98 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/94 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.43% 1/234 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Psychiatric disorders Obsessive-compulsive disorder	0.00% 0/97 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/98 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/94 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.43% 1/234 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Psychiatric disorders Suicidal ideation	0.00% 0/97 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/98 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/94 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.43% 1/234 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Renal and urinary disorders Renal injury	0.00% 0/97 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/98 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/94 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.43% 1/234 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/97 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/98 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	1.1% 1/94 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/97 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/98 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	1.1% 1/94 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/97 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	1.0% 1/98 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	1.1% 1/94 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.

Other adverse events

Other adverse events
Measure	Initial Treatment Period - Tralokinumab 300 Q2W n=97 participants at risk Initial Treatment Period - Tralokinumab 300 Q2W (n=97, PYE=29.48)	Initial Treatment Period - Tralokinumab 150 Q2W n=98 participants at risk Initial Treatment Period - Tralokinumab 150 Q2W (n=98, PYE=29.33)	Initial Treatment Period - Placebo n=94 participants at risk Initial Treatment Period - Placebo (n=94, PYE=27.93)	Maintenance Treatment Period - Tralokinumab 300 Q2W n=11 participants at risk Maintenance Treatment Period - Tralokinumab 300 Q2W (n=11, PYE=5.61)	Maintenance Treatment Period - Tralokinumab 300 Q4W n=13 participants at risk Maintenance Treatment Period - Tralokinumab 300 Q4W (n=13, PYE=6.78)	Maintenance Treatment Period - Tralokinumab 150 Q2W n=12 participants at risk Maintenance Treatment Period - Tralokinumab 150 Q2W (n=12, PYE=6.40)	Maintenance Treatment Period - Tralokinumab 150 Q4W n=14 participants at risk Maintenance Treatment Period - Tralokinumab 150 Q4W (n=14, PYE=6.53)	Maintenance Treatment Period - Placebo n=6 participants at risk Maintenance Treatment Period - Placebo (n=6, PYE=2.98)	Open-label Treatment - Tralokinumab 300 Q2W + Optional TCS n=234 participants at risk Open-label Treatment - Tralokinumab 300 Q2W + optional TCS (n=234, PYE=151.12)	Safety Follow-up n=234 participants at risk Safety Follow-up (n=234, PYE=54.00)
Endocrine disorders Adrenal insufficiency	0.00% 0/97 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/98 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/94 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	9.1% 1/11 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Eye disorders Cataract	0.00% 0/97 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/98 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/94 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	9.1% 1/11 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Eye disorders Conjunctivitis allergic	2.1% 2/97 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	2.0% 2/98 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	2.1% 2/94 • Number of events 3 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	8.3% 1/12 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	7.1% 1/14 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	1.7% 4/234 • Number of events 4 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
General disorders Fatigue	0.00% 0/97 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	4.1% 4/98 • Number of events 4 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	4.3% 4/94 • Number of events 4 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	9.1% 1/11 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
General disorders Injection site reaction	2.1% 2/97 • Number of events 3 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	6.1% 6/98 • Number of events 9 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/94 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	7.7% 1/13 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	4.3% 10/234 • Number of events 16 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
General disorders Malaise	0.00% 0/97 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	1.0% 1/98 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/94 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	8.3% 1/12 • Number of events 6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.85% 2/234 • Number of events 12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Immune system disorders Hypersensitivity	0.00% 0/97 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/98 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/94 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	9.1% 1/11 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.43% 1/234 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Infections and infestations Acute sinusitis	0.00% 0/97 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/98 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	1.1% 1/94 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	8.3% 1/12 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Infections and infestations Bacterial vaginosis	0.00% 0/97 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/98 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/94 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	7.7% 1/13 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Infections and infestations Conjunctivitis	0.00% 0/97 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	2.0% 2/98 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/94 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	7.7% 1/13 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	1.7% 4/234 • Number of events 6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.85% 2/234 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Infections and infestations Furuncle	0.00% 0/97 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/98 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/94 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	16.7% 1/6 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Infections and infestations Herpes zoster	0.00% 0/97 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	1.0% 1/98 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/94 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	16.7% 1/6 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.43% 1/234 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Infections and infestations Infectious mononucleosis	0.00% 0/97 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/98 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/94 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	8.3% 1/12 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Infections and infestations Influenza	2.1% 2/97 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	2.0% 2/98 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	1.1% 1/94 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	18.2% 2/11 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	1.3% 3/234 • Number of events 3 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.85% 2/234 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Infections and infestations Oral herpes	0.00% 0/97 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/98 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	1.1% 1/94 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	9.1% 1/11 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	2.6% 6/234 • Number of events 7 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Infections and infestations Pharyngitis	0.00% 0/97 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	2.0% 2/98 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	4.3% 4/94 • Number of events 4 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	25.0% 3/12 • Number of events 4 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	2.6% 6/234 • Number of events 6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.43% 1/234 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Infections and infestations Upper respiratory tract infection	11.3% 11/97 • Number of events 11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	8.2% 8/98 • Number of events 10 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	4.3% 4/94 • Number of events 5 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	18.2% 2/11 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	8.3% 1/12 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	7.1% 1/14 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	10.7% 25/234 • Number of events 34 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	1.3% 3/234 • Number of events 3 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Infections and infestations Viral upper respiratory tract infection	12.4% 12/97 • Number of events 16 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	19.4% 19/98 • Number of events 22 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	8.5% 8/94 • Number of events 10 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	18.2% 2/11 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	7.7% 1/13 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	8.3% 1/12 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	7.1% 1/14 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	18.8% 44/234 • Number of events 60 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.43% 1/234 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Injury, poisoning and procedural complications Inappropriate schedule of drug administration	0.00% 0/97 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	1.0% 1/98 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/94 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	7.7% 1/13 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.85% 2/234 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Injury, poisoning and procedural complications Procedural anxiety	0.00% 0/97 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/98 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/94 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	9.1% 1/11 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.43% 1/234 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Injury, poisoning and procedural complications Wrong drug administered	1.0% 1/97 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/98 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/94 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	16.7% 1/6 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/97 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/98 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/94 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	7.1% 1/14 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.43% 1/234 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Nervous system disorders Headache	6.2% 6/97 • Number of events 6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	5.1% 5/98 • Number of events 5 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	3.2% 3/94 • Number of events 3 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	5.1% 12/234 • Number of events 17 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Nervous system disorders Migraine	0.00% 0/97 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/98 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	1.1% 1/94 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	7.1% 1/14 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.85% 2/234 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Psychiatric disorders Abnormal behaviour	0.00% 0/97 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/98 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/94 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	9.1% 1/11 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Psychiatric disorders Attention deficit/hyperactivity disorder	0.00% 0/97 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/98 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/94 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	7.1% 1/14 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	4.1% 4/97 • Number of events 4 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	1.0% 1/98 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	3.2% 3/94 • Number of events 3 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	7.7% 1/13 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	7.1% 1/14 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	1.7% 4/234 • Number of events 4 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	1.0% 1/97 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/98 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	1.1% 1/94 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	7.7% 1/13 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.85% 2/234 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Skin and subcutaneous tissue disorders Acne	3.1% 3/97 • Number of events 3 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/98 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	4.3% 4/94 • Number of events 4 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	8.3% 1/12 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	7.1% 1/14 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	1.3% 3/234 • Number of events 3 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.43% 1/234 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/97 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/98 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/94 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	8.3% 1/12 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Skin and subcutaneous tissue disorders Dermatitis atopic	7.2% 7/97 • Number of events 7 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	12.2% 12/98 • Number of events 16 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	11.7% 11/94 • Number of events 15 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	8.3% 1/12 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	14.3% 2/14 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	16.7% 1/6 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	8.1% 19/234 • Number of events 26 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	3.4% 8/234 • Number of events 9 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/97 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	1.0% 1/98 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/94 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	8.3% 1/12 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.43% 1/234 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.	0.00% 0/234 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.

Additional Information

Disclosure Specialist

LEO Pharma A/S

Phone: +45 44945888

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee LEO Pharma seeks publication of all Phase 3 clinical trials in peer-reviewed journals within 18 months of trial completion, regardless of whether the findings are positive or negative. If there is no multi-centre publication within 18 months after the clinical trial has been completed or terminated at all trial sites, the investigator has the right to publish the results from the clinical trial generated by the investigator.
Publication restrictions are in place

Restriction type: OTHER