A Study to Evaluate Long-Term Maintenance Treatment With Once Daily Crisaborole Ointment 2% in Pediatric and Adult Participants With Mild-to-Moderate Atopic Dermatitis

A Phase 3, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Maintenance Treatment and Flare Reduction With Crisaborole Ointment, 2%, Once Daily Over 52 Weeks in Pediatric and Adult Participants (Ages 3 Months and Older) With Mild-to-Moderate Atopic Dermatitis, Who Responded to Twice Daily Crisaborole Ointment, 2%, Treatment

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04040192

Enrollment

620

Registered

2019-07-31

Start date

2019-09-12

Completion date

2022-01-19

Last updated

2023-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Keywords

Eczema, Crisaborole

Brief summary

This study will evaluate crisaborole therapy once daily (QD) as a long-term topical maintenance therapy for the reduction of flare in responders to crisaborole twice daily (BID) treatment.

Detailed description

Approximately 700 participants will be enrolled in an run-in period to receive crisaborole, BID for up to a maximum of 8 weeks to identify crisaborole responders. A responder is defined as a participant who achieves both ISGA and EASI50 success. ISGA success is defined as achieving a score of 0 or 1 with at least 2 grade improvement from baseline; and the EASI50 success is defined as at least 50% improvement from baseline. Non responders at the end of the 8-week run-in period will be discontinued from the study. Approximately 250 responders will be randomized (1:1 ratio) to enter the double-blind maintenance treatment period to receive crisaborole or vehicle QD for 52 weeks, with follow-up assessments every 4 weeks. If a flare occurs and if the participant meets the criteria for having a flare (ISGA ≥2), the participant will switch to enter a flare treatment period to receive open-label crisaborole BID for up to 12 weeks with follow-up assessments every 4 weeks. If the flare has resolved (ISGA ≤1) the participant will resume maintenance treatment and respective visit schedule. If a flare does not resolve after 3 consecutive treatment courses the participant will discontinue the study. A flare treatment period may comprise up to 3 consecutive treatment courses with crisaborole BID (each course is 4 weeks). An end of study (EOS) safety follow-up is required 4 weeks after the last study treatment of any treatment period.

Interventions

DRUGCrisaborole 2%

Crisaborole ointment 2%

DRUGVehicle

Vehicle ointment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

3 Months to No maximum

Healthy volunteers

Inclusion criteria

* Male or female * 3 months of age and older * Confirmed diagnosis of atopic dermatitis according to Hanifin and Rajka criteria * Minimum of 5% BSA affected by atopic dermatitis * ISGA score of Mild (2) or Moderate (3)

Exclusion criteria

\- Has any clinically significant medical disorder, condition, or disease (including active or potentially recurrent non AD dermatological conditions and known genetic dermatological conditions that overlap with AD, such as Netherton syndrome).

Design outcomes

Primary

Measure	Time frame	Description
Duration of Flare-Free Maintenance Until Onset of First-Flare During the Double Blind (DB) Period	From randomization to first flare or last ISGA assessment (up to 52 weeks)	The duration of flare-free maintenance was the time from randomization to the last Investigator's Static Global Assessment (ISGA) and was right censored, if an intercurrent event (eg, death, dropout, loss to follow up, or end of study) occurred before the first flare. When a flare occurred first, the duration of flare free maintenance was the time from randomization to the first flare and was not censored. Duration of flare free maintenance was estimated using the Kaplan-Meier method.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	Crisaborole 2% BID: From start of study intervention in OL period up to 8 weeks ; Vehicle QD and crisaborole 2% QD: From start of study intervention in DB period up to 28 days after last dose of study intervention (maximum of 56 weeks)	An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started on or after the treatment period start date and before end of study (at least 28 days after last dose of study intervention).

Secondary

Measure	Time frame	Description
Secondary: Duration of Pruritus Response Maintenance Until Onset of First Flare During the DB Period: Participants Aged >=12 Years With Baseline Peak Pruritus Numerical Rating Scale (PP NRS) >=3, >=4 and >=3, >=4 Points Reduction in PP NRS	From randomization up to loss of pruritus response or onset of first flare or the last assessment (maximum of 52 weeks)	Duration of pruritus response maintenance=time from randomization to loss of pruritus response or first flare onset(ISGA\>=2) during 52-week DB period evaluated among pruritus responders at randomization. Responders=participants with success in ISGA and EASI50 criteria. Pruritus response maintenance=maintenance of \>=50% improvement in pruritus from baseline obtained at randomization. If event (e.g., death, first flare\[ISGA \>=2\], lost to follow up or end of study) occurred before loss of pruritus response for first flare-free period, duration of pruritus response maintenance was time from randomization to last assessment and was censored. Here,pruritus response maintenance duration was presented for participants aged \>=12 years with OL baseline PP NRS \>=3, \>=4 and \>=3, \>=4 points reduction from OL baseline to randomization in PP NRS. PP NRS: Participants were asked to rate their itch at worst moment during previous 24 hours on a scale of 0 to 10; 0=no itch and 10=worst itch imaginable.
Secondary: Duration of Pruritus Response Maintenance Until Onset of First Flare During the DB Period: Participants Aged 6 to <12 Years With Baseline Patient Reported Itch Severity (PRIS) >=2 and >=2 Points Reduction in PRIS	From randomization up to loss of pruritus response or onset of first flare or the last assessment (maximum of 52 weeks)	Duration of pruritus response maintenance=time from randomization to loss of pruritus response or first flare onset (ISGA\>=2) during 52-week DB period. Evaluated among pruritus responders at randomization. Responders were defined as participants with success in ISGA and EASI50 criteria. Pruritus response maintenance=maintenance of \>=50% improvement in pruritus from baseline that was obtained at randomization. If an event (e.g., death, first flare \[ISGA \>=2\], lost to follow up, or end of study) occurred before loss of pruritus response for first flare-free period, duration of maintenance of pruritus response was time from randomization to last assessment and was censored. Here, pruritus response maintenance duration was presented for participants aged 6 to \<12 years with baseline PRIS \>=2 and \>=2 points reduction from baseline to randomization in PRIS. PRIS: a 5-point scale (range: 0=no itch to 4=worst itch imaginable) and was completed by participants.
Duration of Pruritus Response Maintenance Until Onset of First Flare During the DB Period: Observer Reported Itch Severity Scale (ORIS) in Participants Aged 3 to <6 Months	From randomization up to loss of pruritus response or onset of first flare or the last assessment (maximum of 52 weeks)	Duration of pruritus response maintenance=time from randomization to loss of pruritus response or first flare onset(ISGA\>=2)during52-weekDB period. Evaluated among pruritus responders (success in ISGA, EASI 50) at randomization. Pruritus response maintenance=maintenance of \>=50% improvement in pruritus from baseline obtained at randomization. If event(e.g., death, first flare\[ISGA \>=2\], lost to follow up, or end of study) occurred before loss of pruritus response for first flare-free period, duration of maintenance of pruritus response was time from randomization to last assessment and was censored. Here, pruritus response maintenance duration was presented for participants aged 3 to \<6 months with OL baseline ORIS\>=3 or \>=4 and \>=3 or \>=4 points reduction from OL baseline to randomization in ORIS. Caregivers were asked to rate observation of their child's itch(scratching, rubbing) at worst moment during previous 24 hours on a scale of 0 to 10;0=no itch,10=worst itch imaginable.
Duration of Maintenance of >=50% Reduction in Eczema Area and Severity Index (EASI) Total Score Until Onset of First Flare During the DB Period	From randomization to loss of EASI response or onset of first flare or the last EASI assessment (up to maximum of 52 weeks)	EASI assessed severity of AD, based on severity of lesion clinical signs (erythema \[E\], induration/papulation \[I\], excoriation \[Ex\], lichenification \[L\]) and % body surface area (BSA) affected. Each of clinical signs scored separately for each of 4 body regions (head and neck \[h\], upper limbs \[u\], trunk \[t\] \[including axillae and groin\], lower limbs \[l\] \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score (A) according to %BSA with AD: 0 (0%), 1(\>0 to \<10%), 2(10 to \<30%), 3(30 to \<50%), 4(50 to \<70%), 5(70 to \<90%), 6 (90 to 100%). Total EASI score =0.1\Ah\(Eh + Ih + Exh + Lh) + 0.2\Au\(Eu + Iu + ExU + Lu) + 0.3\At\(Et +It + Ext + Lt) + 0.4\Al\(El + Il + Exl + Ll). Total EASI score ranged from 0.0 to 72.0, higher score = greater severity of AD. EASI response maintenance = score that does not lose more than 50% of achieved reduction from Day1/Baseline run-in EASI score.
Duration of Maintenance of Dermatology Life Quality Index (DLQI) Response Until Onset of First Flare During the DB Period	From randomization to loss of DLQI response or onset of first flare or the last assessment up to first flare (up to maximum of 52 weeks)	Duration of DLQI maintenance=time from randomization to loss of DLQI response during 52-week DB period for responders at randomization. If event(e.g., death, first flare\[ISGA \>=2\], lost to follow up or end of study) occurred before loss of DLQI response, duration of maintenance of DLQI response=time from randomization to last assessment and censored. Responders=participants with success in ISGA,EASI50 criteria. DLQI response maintenance=response that does not lose more than minimal clinical important difference. DLQI =10-item questionnaire, measured impact of skin disease in participants aged \>=16 years. Children's DLQI (CDLQI): participants aged 4 to15 years. Each question in DLQI and CDLQI evaluated on 4-point scale (range 0=not at all to 3=very much). Scores from10 items were added for DLQI/CDLQI total score, range:0 (not at all) to 30 (very much). Higher scores=more impact on quality of life of participants/children.
Duration of Maintenance of Patient Oriented Eczema Measure (POEM) Response Until Onset of First Flare During the DB Period	From randomization to loss POEM response or onset of first flare or the last assessment up to the first flare (up to maximum of 52 weeks)	POEM was a 7-item participant reported outcome measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item was scored as: no days=0, 1-2 days=1, 3-4 days=2, 5-6 days=3 and every day=4. The total score ranged from 0 to 28, where higher score indicated greater severity. POEM response maintenance was defined as the response that does not lose more than minimal clinical important difference. Duration of POEM maintenance was time from randomization to loss of POEM response during 52-week DB period for responders at randomization. Responders were defined as participants with success in ISGA and EASI50 criteria. If an event (e.g., death, first flare \[ISGA \>=2\], lost to follow up, or end of study) occurred before loss of POEM response, duration of maintenance of POEM response was time from randomization to last assessment and was censored. Proxy POEM was used for participants aged 3 months to \<12 years.
Investigator's Static Global Assessment (ISGA) Score for the First Flare Period	Week 0 (Day 1), Week 4, Week 8 and Week 12	ISGA:5- point global assessment scale of AD severity, used to characterize overall disease severity across all treatable AD lesions (excluding the scalp). Score ranged from 0 to 4: where 0= clear(minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicate greater severity of AD. First flare period was the time from the onset of flare (ISGA\>=2) during DB maintenance period where the participant was switched to receive open-label crisaborole ointment 2%, BID for up to 12 weeks until resolution of flares.
EASI Score for the First Flare Period	Week 0 (Day 1), Week 4, Week 8 and Week 12	EASI assessed severity of AD, based on severity of lesion clinical signs (erythema\[E\], induration/papulation\[I\], excoriation\[Ex\], lichenification\[L\]) and % body surface area(BSA) affected.Each of clinical signs scored separately for each of 4 body regions (head and neck\[h\], upper limbs\[u\], trunk\[t\] \[including axillae and groin\], lower limbs\[l\] \[including buttocks\]) on 4-point scale: 0= absent; 1=mild; 2= moderate; 3= severe.EASI area score(A) according to %BSA with AD: 0 (0%), 1(\>0 to \<10%), 2(10 to \<30%), 3(30 to \<50%), 4(50 to \<70%), 5(70 to \<90%), 6 (90 to 100%). Total EASI score =0.1\Ah\(Eh + Ih + Exh + Lh) + 0.2\Au\(Eu + Iu + ExU + Lu) + 0.3\At\(Et +It + Ext + Lt) + 0.4\Al\(El + Il + Exl + Ll). Total EASI score ranged from 0.0 to 72.0, higher score = greater severity of AD.First flare period=time from onset of flare(ISGA\>=2) during DB maintenance period where participant was switched to receive open-label crisaborole ointment 2%,BID for up to 12 weeks until resolution of flares.
Duration (Days) of Flare Period	Up to 52 weeks	Duration of flare period was average duration calculated from sum of durations divided by number of flares for each participant.
Percent Change From Baseline in EASI Scores at Weeks 2, 4, 6 and 8: OL Run-in Period	Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8	EASI assessed severity of AD, based on severity of lesion clinical signs (erythema \[E\], induration/papulation \[I\], excoriation \[Ex\], lichenification \[L\]) and % body surface area (BSA) affected. Each of clinical signs scored separately for each of 4 body regions (head and neck \[h\], upper limbs \[u\], trunk \[t\] \[including axillae and groin\], lower limbs \[l\] \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score (A) according to %BSA with AD: 0 (0%), 1(\>0 to \<10%), 2(10 to \<30%), 3(30 to \<50%), 4(50 to \<70%), 5(70 to \<90%), 6 (90 to 100%). Total EASI score =0.1\Ah\(Eh + Ih + Exh + Lh) + 0.2\Au\(Eu + Iu + ExU + Lu) + 0.3\At\(Et +It + Ext + Lt) + 0.4\Al\(El + Il + Exl + Ll). Total EASI score ranged from 0.0 to 72.0, higher score = greater severity of AD.
Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period	Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	EASI assessed severity of AD, based on severity of lesion clinical signs (erythema \[E\], induration/papulation \[I\], excoriation \[Ex\], lichenification \[L\]) and % body surface area (BSA) affected. Each of clinical signs scored separately for each of 4 body regions (head and neck \[h\], upper limbs \[u\], trunk \[t\] \[including axillae and groin\], lower limbs \[l\] \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score (A) according to %BSA with AD: 0 (0%), 1(\>0 to \<10%), 2(10 to \<30%), 3(30 to \<50%), 4(50 to \<70%), 5(70 to \<90%), 6 (90 to 100%). Total EASI score =0.1\Ah\(Eh + Ih + Exh + Lh) + 0.2\Au\(Eu + Iu + ExU + Lu) + 0.3\At\(Et +It + Ext + Lt) + 0.4\Al\(El + Il + Exl + Ll). Total EASI score ranged from 0.0 to 72.0, higher score = greater severity of AD.
Percent Change From Baseline in EASI Scores at Weeks 0, 4, 8 and 12: First Flare Treatment Period	Baseline (last observation up to and including the randomization day of DB period),Weeks 0, 4, 8 and 12	EASI assessed severity of AD, based on severity of lesion clinical signs (erythema \[E\], induration/papulation \[I\], excoriation \[Ex\], lichenification \[L\]) and % body surface area (BSA) affected. Each of clinical signs scored separately for each of 4 body regions (head and neck \[h\], upper limbs \[u\], trunk \[t\] \[including axillae and groin\], lower limbs \[l\] \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score (A) according to % BSA with AD: 0 (0%), 1(\>0 to \<10%), 2(10 to \<30%), 3(30 to \<50%), 4(50 to \<70%), 5(70 to \<90%), 6 (90 to 100%). Total EASI score =0.1\Ah\(Eh + Ih + Exh + Lh) + 0.2\Au\(Eu + Iu + ExU + Lu) + 0.3\At\(Et +It + Ext + Lt) + 0.4\Al\(El + Il + Exl + Ll). Total EASI score ranged from 0.0 to 72.0, higher score = greater severity of AD.
Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period	Baseline (last observation up to and including the randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	EASI assessed severity of AD, based on severity of lesion clinical signs (erythema \[E\], induration/papulation \[I\], excoriation \[Ex\], lichenification \[L\]) and % body surface area (BSA) affected. Each of clinical signs scored separately for each of 4 body regions (head and neck \[h\], upper limbs \[u\], trunk \[t\] \[including axillae and groin\], lower limbs \[l\] \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score (A) according to %BSA with AD: 0 (0%), 1(\>0 to \<10%), 2(10 to \<30%), 3(30 to \<50%), 4(50 to \<70%), 5(70 to \<90%), 6 (90 to 100%). Total EASI score =0.1\Ah\(Eh + Ih + Exh + Lh) + 0.2\Au\(Eu + Iu + ExU + Lu) + 0.3\At\(Et +It + Ext + Lt) + 0.4\Al\(El + Il + Exl + Ll). Total EASI score ranged from 0.0 to 72.0, higher score = greater severity of AD.
Change From Baseline in ISGA Scores at Weeks 2, 4, 6 and 8 for OL run-in Period	Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8	ISGA is a 5- point global assessment scale, used to characterize overall disease severity across all treatable AD lesions (excluding the scalp). Score ranged from 0 to 4: where 0= clear(minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicate greater severity of AD.
Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	ISGA is a 5- point global assessment scale, used to characterize overall disease severity across all treatable AD lesions (excluding the scalp). Score ranged from 0 to 4: where 0= clear(minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicate greater severity of AD.
Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period	Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	ISGA is a 5- point global assessment scale, used to characterize overall disease severity across all treatable AD lesions (excluding the scalp). Score ranged from 0 to 4: where 0= clear(minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicate greater severity of AD.
Change From Baseline in ISGA Scores at Weeks 0, 4, 8 and 12 for First Flare Treatment Period	Baseline (last observation up to and including the randomization day), Weeks 0, 4, 8 and 12	ISGA:5-point global assessment scale, used to characterize overall disease severity across all treatable AD lesions (excluding scalp). Score ranged:0 to 4,where 0=clear(minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1=almost clear(trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2=mild(faint pink erythema with mild induration/papulation and no oozing/crusting), 3=moderate(pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4=severe(deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicate greater severity of AD. The period for which OL crisaborole 2% ointment BID was initiated for treatment of flare developed during DB maintenance until resumption of DB treatment was defined as flare treatment period.
Change From Baseline in Treatable Percent Body Surface Area (% BSA): OL Run-in Period	Baseline (last observation up to and including the randomization day) Weeks 2, 4, 6 and 8	The extent (%) to which a body region was involved with AD was determined using handprint method. Four body regions evaluated: head and neck (hn), upper limbs (ul), trunk (tr) (including axillae) and lower limbs (ll) (including buttocks). Total number of handprints=10 for hn, 20 for ul, 30 for tr, 40 for ll in participants aged \>=8 years; 20 for hn, 20 for ul, 30 for tr, 30 for ll in participants aged 3 months to 7 years. Surface area of body region equivalent to 1 handprint: 10% for hn, 5% for ul, 3.33% for tr, 2.5% for ll in participants aged \>=8 years; 5% for hn, 5% for ul, 3.33% for tr, 3.33% for ll in participants aged 3 months to 7 years. % BSA for a body region= total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall % BSA for an individual=sum of % BSA across all 4 body regions and ranged from 0 to 100%, with higher values representing greater extent of BSA involvement with AD.
Change From Baseline in Treatable %BSA: DB Period	Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	The extent (%) to which a body region was involved with AD was determined using handprint method. Four body regions evaluated: head and neck (hn), upper limbs (ul), trunk (tr) (including axillae) and lower limbs (ll) (including buttocks). Total number of handprints=10 for hn, 20 for ul, 30 for tr, 40 for ll in participants aged \>=8 years; 20 for hn, 20 for ul, 30 for tr, 30 for ll in participants aged 3 months to 7 years. Surface area of body region equivalent to 1 handprint: 10% for hn, 5% for ul, 3.33% for tr, 2.5% for ll in participants aged \>=8 years; 5% for hn, 5% for ul, 3.33% for tr, 3.33% for ll in participants aged 3 months to 7 years. % BSA for a body region= total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall % BSA for an individual=sum of % BSA across all 4 body regions and ranged from 0 to 100%, with higher values representing greater extent of BSA involvement with AD.
Change From Baseline in Treatable %BSA: First Flare Free Period	Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	The extent (%) to which a body region was involved with AD was determined using handprint method. Four body regions evaluated: head and neck (hn), upper limbs (ul), trunk (tr) (including axillae) and lower limbs (ll) (including buttocks). Total number of handprints=10 for hn, 20 for ul, 30 for tr, 40 for ll in participants aged \>=8 years; 20 for hn, 20 for ul, 30 for tr, 30 for ll in participants aged 3 months to 7 years. Surface area of body region equivalent to 1 handprint: 10% for hn, 5% for ul, 3.33% for tr, 2.5% for ll in participants aged \>=8 years; 5% for hn, 5% for ul, 3.33% for tr, 3.33% for ll in participants aged 3 months to 7 years. % BSA for a body region= total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall % BSA for an individual=sum of % BSA across all 4 body regions and ranged from 0 to 100%, with higher values representing greater extent of BSA involvement with AD.
Change From Baseline in Treatable %BSA: First Flare Period	Baseline (last observation up to and including the randomization day), Weeks 0, 4, 8 and 12	The extent (%) to which a body region was involved with AD was determined using handprint method. Four body regions evaluated: head and neck (hn), upper limbs (ul), trunk (tr) (including axillae) and lower limbs (ll) (including buttocks). Total number of handprints=10 for hn, 20 for ul, 30 for tr, 40 for ll in participants aged \>=8 years; 20 for hn, 20 for ul, 30 for tr, 30 for ll in participants aged 3 months to 7 years. Surface area of body region equivalent to 1 handprint: 10% for hn, 5% for ul, 3.33% for tr, 2.5% for ll in participants aged \>=8 years; 5% for hn, 5% for ul, 3.33% for tr, 3.33% for ll in participants aged 3 months to 7 years. % BSA for a body region= total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall % BSA for an individual=sum of % BSA across all 4 body regions and ranged from 0 to 100%, with higher values representing greater extent of BSA involvement with AD.
Change From Baseline in Most Commonly Affected Atopic Dermatitis (AD) % BSA: DB Period	Baseline (last observation up to and including the randomization day), Weeks 24 and 52	The investigators were required to draw the skin areas affected by AD for each participant in a body map and the most commonly affected BSA was documented.
Night Time Itch Score for Participants >=12 Years of Age: OL Run-in Period	Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8	The severity and frequency of itch (pruritus) during the night due to AD was assessed using a horizontal scale. Participants 12 years of age or older were asked to assess their worst itching and frequency of itching due to AD during their most recent night's sleep on a scale of 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch. Scale range of Frequency of night time itch was 0 to 10, where 0=no and 10=the most frequency imaginable. Higher score indicated higher frequency.
Night Time Itch Score for Participants >=12 Years of Age: DB Period	Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	The severity and frequency of itch (pruritus) during the night due to AD was assessed using a horizontal scale. Participants 12 years of age or older were asked to assess their worst itching and frequency of itching due to AD during their most recent night's sleep on a scale of 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch. Scale range of Frequency of night time itch was 0 to 10, where 0=no and 10=the most frequency imaginable. Higher score indicated higher frequency.
Night Time Itch Score for Participants >=12 Years of Age: First Flare Period	Weeks 0, 4, 8 and 12	The severity and frequency of itch (pruritus) during the night due to AD was assessed using a horizontal scale. Participants 12 years of age or older were asked to assess their worst itching and frequency of itching due to AD during their most recent night's sleep on a scale of 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch. Scale range of Frequency of night time itch was 0 to 10, where 0=no and 10=the most frequency imaginable. Higher score indicated higher frequency.
Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	The severity and frequency of itch (pruritus) during the night due to AD was assessed using a horizontal scale. Participants 12 years of age or older were asked to assess their worst itching and frequency of itching due to AD during their most recent night's sleep on a scale of 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch. Scale range of Frequency of night time itch was 0 to 10, where 0=no and 10=the most frequency imaginable. Higher score indicated higher frequency.
AD Skin Pain Scores for Participants >=12 Years of Age: OL Run-in Period	Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8	Participants 12 years of age or older were asked to assess their worst skin pain due to AD at the analysis time, with the question: 'AD skin pain right now' using the skin pain numerical rating scale (NRS). Skin pain NRS was a 11-point horizontal scale anchored at 0 and 10, with 0 representing no pain and 10 representing worst pain imaginable. Higher scores indicated worse pain.
AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Participants 12 years of age or older were asked to assess their worst skin pain due to AD at the analysis time, with the question: 'AD skin pain right now' using the skin pain numerical rating scale (NRS). Skin pain NRS was a 11-point horizontal scale anchored at 0 and 10, with 0 representing no pain and 10 representing worst pain imaginable. Higher scores indicated worse pain.
AD Skin Pain Scores for Participants >=12 Years of Age: First Flare Period	Weeks 0, 4, 8, 12	Participants 12 years of age or older were asked to assess their worst skin pain due to AD at the analysis time, with the question: 'AD skin pain right now' using the skin pain numerical rating scale (NRS). Skin pain NRS was a 11-point horizontal scale anchored at 0 and 10, with 0 representing no pain and 10 representing worst pain imaginable. Higher scores indicated worse pain.
AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period	Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Participants 12 years of age or older were asked to assess their worst skin pain due to AD at the analysis time, with the question: 'AD skin pain right now' using the skin pain NRS. Skin pain NRS was a 11-point horizontal scale anchored at 0 and 10, with 0 representing no pain and 10 representing worst pain imaginable. Higher scores indicated worse pain.
Patient/Observer Global Impression of Severity Score: OL Run-in Period	Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8	Patient/Observer Global Impression of Severity (PGIS/OGIS) is a single item participant or observer rated measure of the participant's AD condition severity at a given point in time using a 7-point rating scale, which ranges from 1 to 7, where 1=not present to 7=extremely severe. The PGIS was completed by all participants \>=12 years of age and OGIS was completed by the observer for participants 3 months-\<12 years of age.
Patient/Observer Global Impression of Severity Score: DB Period	Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	PGIS/OGIS is a single item participant or observer rated measure of the participant's AD condition severity at a given point in time using a 7-point rating scale, which ranges from 1 to 7, where 1=not present to 7=extremely severe. The PGIS was completed by all participants \>=12 years of age and OGIS was completed by the observer for participants 3 months-\<12 years of age.
Patient/Observer Global Impression of Severity Score: First Flare Period	Weeks 0, 4, 8 and 12	PGIS/OGIS is a single item participant or observer rated measure of the participant's AD condition severity at a given point in time using a 7-point rating scale, which ranges from 1 to 7, where 1=not present to 7=extremely severe. The PGIS was completed by all participants \>=12 years of age and OGIS was completed by the observer for participants 3 months-\<12 years of age.
Patient/Observer Global Impression of Severity Score: First Flare Free Period	Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	PGIS/OGIS is a single item participant or observer rated measure of the participant's AD condition severity at a given point in time using a 7-point rating scale, which ranges from 1 to 7, where 1=not present to 7=extremely severe. The PGIS was completed by all participants \>=12 years of age and OGIS was completed by the observer for participants 3 months-\<12 years of age.
Patient/Observer Global Impression of Change Score: OL Run-in Period	Weeks 2, 4, 6 and 8	Patient/Observer Global Impression of Change (PGIC/OGIC) is a single item instrument using 7-point rating scale and was used to determine global improvement at a given point in time since the start of study drug. The scores ranged from 1=very much improved to 7=very much worse. The PGIC was completed by all participants \>=12 years of age and OGIC was completed by the observer for participants 3 months-\<12 years of age.
Patient/Observer Global Impression of Change Score: DB Period	Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	PGIC/OGIC is a single item instrument using 7-point rating scale and was used to determine global improvement at a given point in time since the start of study drug. The scores ranged from 1=very much improved to 7=very much worse. The PGIC was completed by all participants \>=12 years of age and OGIC was completed by the observer for participants 3 months-\<12 years of age.
Patient/Observer Global Impression of Change Score: First Flare Period	Weeks 0, 4, 8 and 12	PGIC/OGIC is a single item instrument using 7-point rating scale and was used to determine global improvement at a given point in time since the start of study drug. The scores ranged from 1=very much improved to 7=very much worse. The PGIC was completed by all participants \>=12 years of age and OGIC was completed by the observer for participants 3 months-\<12 years of age.
Patient/Observer Global Impression of Change Score: First Flare Free Period	Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	PGIC/OGIC is a single item instrument using 7-point rating scale and was used to determine global improvement at a given point in time since the start of study drug. The scores ranged from 1=very much improved to 7=very much worse. The PGIC was completed by all participants \>=12 years of age and OGIC was completed by the observer for participants 3 months-\<12 years of age.
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8	The Medical Outcomes Study (MOS) Sleep Scale is a 12-item measure that is segregated into subscales addressing seven sleep domains (i.e. sleep disturbance, snoring, short of breath or headache, adequacy of sleep, somnolence, sleep problems index I and sleep problems index II) and a single item assessing quantity of sleep. Quantity of sleep scores ranged from 0 to 24 (number of hours slept) and Optimal Sleep score ranged from 0 (no) to 1(yes) based on whether the participant slept for 7-8 hours per night, All other subscales including sleep problems index 1 and 2:were scored on a range of 0 to 100 where, higher scores=greater impairment. Observed scores for each individual sleep domain and quantity of sleep are reported in this outcome measure.
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Baseline (the last observation up to and including Day 1 of DB period),Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	MOS Sleep Scale is a 12-item measure that is segregated into subscales addressing seven sleep domains (i.e. sleep disturbance, snoring, short of breath or headache, adequacy of sleep, somnolence, sleep problems index I and sleep problems index II) and a single item assessing quantity of sleep. Quantity of sleep scores ranged from 0 to 24 (number of hours slept) and Optimal Sleep score ranged from 0 (no) to 1(yes) based on whether the participant slept for 7-8 hours per night, All other subscales including sleep problems index 1 and 2:were scored on a range of 0 to 100 where, higher scores=greater impairment. Observed scores for each individual sleep domain and quantity of sleep are reported in this outcome measure.
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Weeks 0, 4, 8 and 12	MOS Sleep Scale is a 12-item measure that is segregated into subscales addressing seven sleep domains (i.e. sleep disturbance, snoring, short of breath or headache, adequacy of sleep, somnolence, sleep problems index I and sleep problems index II) and a single item assessing quantity of sleep. Quantity of sleep scores ranged from 0 to 24 (number of hours slept) and Optimal Sleep score ranged from 0 (no) to 1(yes) based on whether the participant slept for 7-8 hours per night, All other subscales including sleep problems index 1 and 2:were scored on a range of 0 to 100 where, higher scores=greater impairment. Observed scores for each individual sleep domain and quantity of sleep are reported in this outcome measure.
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	MOS Sleep Scale is a 12-item measure that is segregated into subscales addressing seven sleep domains (i.e. sleep disturbance, snoring, short of breath or headache, adequacy of sleep, somnolence, sleep problems index I and sleep problems index II) and a single item assessing quantity of sleep. Quantity of sleep scores ranged from 0 to 24 (number of hours slept) and Optimal Sleep score ranged from 0 (no) to 1(yes) based on whether the participant slept for 7-8 hours per night, All other subscales including sleep problems index 1 and 2:were scored on a range of 0 to 100 where, higher scores=greater impairment. Observed scores for each individual sleep domain and quantity of sleep are reported in this outcome measure.
European Quality of Life-5 Dimension 5-Level (EQ-5D-5L) Index Score in Participants Greater Than or Equal to (>=) 18 Years of Age: OL Run-in Period	Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8	EQ-5D-5L: standardized participant completed questionnaire consisted of 2 components: a health state profile/a single utility index value and an optional VAS. EQ-5D health state profile/a single utility index value had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded no problems for each 5 dimensions, then health state was coded as 11111 with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. US value sets (with all possible health states) was used for adults in the study and total scores ranged from 1 to -0.109. Higher (positive) scores = better health state.
European Quality of Life-5 Dimension Youth (EuroQoL EQ-5D Y) Index Score in Participants Between 8-17 Years of Age: OL Run-in Period	Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8	EQ-5D-Y: child-friendly version of EQ-5D questionnaire related to health status. Health state profile assessed health in 5 dimensions (mobility; looking after myself; doing usual activities; having pain or discomfort; feeling worried, sad or unhappy) used to obtain an index score, each of which had three levels of response (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Participants indicated their health state by choosing the appropriate level from each dimension. The 5 digit health states thus obtained for each dimension were then converted into a single median index value. A health state index score was calculated from individual health profiles using a USA scoring algorithm. Health state index scores generally ranged from -0.109 to 1, where,-0.109= the worst health status, 1= full health. Higher the score the better the health status. A positive change from baseline indicated improvement in health status.
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: OL Run-in Period	Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8	EQ-5D-Y:child-friendly version of EQ-5D questionnaire related to health status.Health state profile assessed health in 5 dimensions(Mobility;Looking After Myself;Doing Usual Activities;Having Pain or Discomfort;Feeling Worried,Sad or Unhappy)used to obtain index score,each of which had three levels of response(no problems/no pain/not worried,some problems/some pain/a bit worried,a lot of problems/a lot of pain/very worried).Participants indicated health state by choosing appropriate level from each dimension.5-digit health states obtained for each dimension were converted into single median index value using index value calculator,recommended by EuroQoL group.Health state index score calculated from individual health profiles using USA scoring algorithm. Scores ranged from -0.109 to 1,where, -0.109=worst health status, 1=full health. Higher score=better health status.Positive change from baseline indicated improvement in health status.Proxy version filled by care-giver of participant
EuroQoL EQ-5D-5L Visual Analog Scale (VAS) Score in Participants >= 18 Years of Age: OL Run-in Period	Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8	EQ-5D-5L VAS was used to record participant's rating for current health-related quality of life state on vertical VAS (0-100);0=worst imaginable health state;100=best imaginable health state.
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age : OL-Run-in Period	Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8	EQ-5D Y VAS was used to record participant's rating for his/her current health-related quality of life state on vertical VAS (0-100);0 = worst imaginable health state and 100 = best imaginable health state.
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: OL Run-in Period	Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8	EQ-5D Y proxy VAS assessed the caregiver's impression of participants health state on a vertical VAS (range: 0 to 100), where, 0 (the worst imaginable health) to 100 (the best imaginable health).
EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	EQ-5D-5L: standardized participant completed questionnaire consisted of 2 components: a health state profile/a single utility index value and an optional VAS. EQ-5D health state profile/a single utility index value had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded no problems for each 5 dimensions, then health state was coded as 11111 with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQoL. US value sets (with all possible health states) was used for adults in the study and total scores ranged from 1 to -0.109. Higher (positive) scores = better health state.
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	EQ-5D-Y: child-friendly version of EQ-5D questionnaire related to health status. Health state profile assessed health in 5 dimensions (mobility; looking after myself; doing usual activities; having pain or discomfort; feeling worried, sad or unhappy) used to obtain an index score, each of which had three levels of response (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Participants indicated their health state by choosing the appropriate level from each dimension. The 5 digit health states thus obtained for each dimension were then converted into a single median index value. A health state index score was calculated from individual health profiles using a USA scoring algorithm. Health state index scores generally ranged from -0.109 to 1, where,-0.109= the worst health status, 1= full health. Higher the score the better the health status. A positive change from baseline indicated improvement in health status.
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	EQ-5D-Y:child-friendly version of EQ-5D questionnaire related to health status.Health state profile assessed health in 5 dimensions(Mobility;Looking After Myself;Doing Usual Activities;Having Pain or Discomfort;Feeling Worried,Sad or Unhappy)used to obtain index score,each of which had three levels of response(no problems/no pain/not worried,some problems/some pain/a bit worried,a lot of problems/a lot of pain/very worried).Participants indicated health state by choosing appropriate level from each dimension.5-digit health states obtained for each dimension were converted into single median index value using index value calculator,recommended by EuroQoL group.Health state index score calculated from individual health profiles using USA scoring algorithm. Scores ranged from -0.109 to 1,where, -0.109=worst health status, 1=full health. Higher score=better health status.Positive change from baseline indicated improvement in health status.Proxy version filled by care-giver of participant.
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	EQ-5D-5L VAS to record participant's rating for current health-related quality of life state on vertical VAS (0-100);0=worst imaginable health state;100=best imaginable health state.
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Baseline (the last observation up to and including Day 1 of OL period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	EQ-5D Y VAS was a child-friendly version of EQ-5D questionnaire related to health status used to record participant's rating for his/her current health-related quality of life state on vertical VAS (0-100);0 = worst imaginable health state and 100 = best imaginable health state.
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Baseline (the last observation up to and including Day 1 of DB period),Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	EQ-5D Y proxy VAS assessed the caregiver's impression of participants health state on a vertical VAS (range: 0 to 100), where, 0 (the worst imaginable health) to 100 (the best imaginable health).
EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: First Flare Period	Weeks 0, 4, 8 and 12	EQ-5D-5L: standardized participant completed questionnaire consisted of 2 components: a health state profile/a single utility index value and an optional VAS. EQ-5D health state profile/a single utility index value had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded no problems for each 5 dimensions, then health state was coded as 11111 with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. US value sets (with all possible health states) was used for adults in the study and total scores ranged from 1 to -0.109. Higher (positive) scores = better health state.
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Period	Weeks 0, 4, 8 and 12	EQ-5D-Y: child-friendly version of EQ-5D questionnaire related to health status. Health state profile assessed health in 5 dimensions (mobility; looking after myself; doing usual activities; having pain or discomfort; feeling worried, sad or unhappy) used to obtain an index score, each of which had three levels of response (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Participants indicated their health state by choosing the appropriate level from each dimension. The 5 digit health states thus obtained for each dimension were then converted into a single median index value. A health state index score was calculated from individual health profiles using a USA scoring algorithm. Health state index scores generally ranged from -0.109 to 1, where,-0.109= the worst health status, 1= full health. Higher the score the better the health status. A positive change from baseline indicated improvement in health status.
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Period	Weeks 0, 4, 8 and 12	EQ-5D-Y:child-friendly version of EQ-5D questionnaire related to health status.Health state profile assessed health in 5 dimensions(Mobility;Looking After Myself;Doing Usual Activities;Having Pain or Discomfort;Feeling Worried,Sad or Unhappy)used to obtain index score,each of which had three levels of response(no problems/no pain/not worried,some problems/some pain/a bit worried,a lot of problems/a lot of pain/very worried).Participants indicated health state by choosing appropriate level from each dimension.5-digit health states obtained for each dimension were converted into single median index value using index value calculator,recommended by EuroQoL group.Health state index score calculated from individual health profiles using USA scoring algorithm. Scores ranged from -0.109 to 1,where, -0.109=worst health status, 1=full health. Higher score=better health status.Positive change from baseline indicated improvement in health status.Proxy version filled by care-giver of participant.
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Period	Weeks 0, 4, 8 and 12	EQ-5D-5L VAS was used to record participant's rating for his/her current health-related quality of life state on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state.
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Period	Weeks 0, 4, 8 and 12	EQ-5D Y VAS was a child-friendly version of EQ-5D questionnaire related to health status used to record participant's rating for his/her current health-related quality of life state on vertical VAS (0-100);0 = worst imaginable health state and 100 = best imaginable health state.
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Period	Weeks 0, 4, 8 and 12	EQ-5D Y proxy VAS assessed the caregiver's impression of participants health state on a vertical VAS (range: 0 to 100), where, 0 (the worst imaginable health) to 100 (the best imaginable health).
EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period	Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	EQ-5D-Y: child-friendly version of EQ-5D questionnaire related to health status. Health state profile assessed health in 5 dimensions (mobility; looking after myself; doing usual activities; having pain or discomfort; feeling worried, sad or unhappy) used to obtain an index score, each of which had three levels of response (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Participants indicated their health state by choosing the appropriate level from each dimension. The 5 digit health states thus obtained for each dimension were then converted into a single median index value. A health state index score was calculated from individual health profiles using a USA scoring algorithm. Health state index scores generally ranged from -0.109 to 1, where,-0.109= the worst health status, 1= full health. Higher the score the better the health status. A positive change from baseline indicated improvement in health status.
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Baseline (the last observation up to and including randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	EQ-5D-Y: child-friendly version of EQ-5D questionnaire related to health status. Health state profile assessed health in 5 dimensions (mobility; looking after myself; doing usual activities; having pain or discomfort; feeling worried, sad or unhappy) used to obtain an index score, each of which had three levels of response (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Participants indicated their health state by choosing the appropriate level from each dimension. The 5 digit health states thus obtained for each dimension were then converted into a single median index value. A health state index score was calculated from individual health profiles using a USA scoring algorithm. Health state index scores generally ranged from -0.109 to 1, where,-0.109= the worst health status, 1= full health. Higher the score the better the health status. A positive change from baseline indicated improvement in health status.
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Baseline (the last observation up to and including randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	EQ-5D-Y:child-friendly version of EQ-5D questionnaire related to health status.Health state profile assessed health in 5 dimensions(Mobility;Looking After Myself;Doing Usual Activities;Having Pain or Discomfort;Feeling Worried,Sad or Unhappy)used to obtain index score,each of which had three levels of response(no problems/no pain/not worried,some problems/some pain/a bit worried,a lot of problems/a lot of pain/very worried).Participants indicated health state by choosing appropriate level from each dimension.5-digit health states obtained for each dimension were converted into single median index value using index value calculator,recommended by EuroQoL group.Health state index score calculated from individual health profiles using USA scoring algorithm. Scores ranged from -0.109 to 1,where, -0.109=worst health status, 1=full health. Higher score=better health status.Positive change from baseline indicated improvement in health status.Proxy version filled by care-giver of participant.
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period	Baseline (the last observation up to and including randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	EQ-5D-5L VAS was used to record participant's rating for current health-related quality of life state on vertical VAS (0-100);0=worst imaginable health state;100=best imaginable health state.
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Baseline (the last observation up to and including randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	EQ-5D Y VAS was a child-friendly version of EQ-5D questionnaire related to health status used to record participant's rating for his/her current health-related quality of life state on vertical VAS (0-100);0 = worst imaginable health state and 100 = best imaginable health state.
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Baseline (the last observation up to and including randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	EQ-5D Y proxy VAS assessed the caregiver's impression of participants health state on a vertical VAS (range: 0 to 100), where, 0 (the worst imaginable health) to 100 (the best imaginable health).
Percent Work Time Missed Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period	Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8	WPAI plus CIQ was a 10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were: Q1= currently employed; Q2= work hours missed due to health problems; Q3= work hours missed due to other reasons; Q4= hours actually worked; Q5= degree health affected productivity while working (0-10 scale, higher scores = less productivity); Q6= classes attended in academic setting or not; Q7= class hours missed due to health problems; Q8= class hours actually attended; Q9= degree health affected productivity while attending (0-10 scale, high scores= less productivity); Q10= degree health affected productivity in regular daily activities (0-10 scale, higher scores = less productivity). Percent work time missed was calculated as: Q2\*100/(Q2+Q4) and score ranged from 0-100%, higher scores = greater impairment and less productivity.
Percent Impairment While Working Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period	Weeks 0, 2, 4, 6 and 8	WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were:Q1= currently employed;Q2= work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4= hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, high scores=less productivity);Q6=classes attended in academic setting or not;Q7= class hours missed due to health problems; Q8= class hours actually attended; Q9= degree health affected productivity while attending(0-10 scale, high scores= less productivity); Q10= degree health affected productivity in regular daily activities (0-10 scale, high scores=less productivity). Percent impairment while working due to health problem was calculated as: 100\*Q5/10 and score ranged from 0-100%,higher scores =greater impairment and less productivity.
Percent Overall Work Impairment Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period	Weeks 0, 2, 4, 6 and 8	WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days.Questions:Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked;Q5=degree health affected productivity while working(0-10 scale, high scores=less productivity);Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale, high scores= less productivity);Q10=degree health affected productivity: regular daily activities (0-10 scale, high scores =less productivity). Percent overall impairment while working due to health problem calculated as:100\*{Q2/(Q2+Q4)+\[(1- Q2/(Q2+Q4))×(Q5/10)\]},score ranged:0-100%,high numbers=greater impairment and less productivity.
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period	Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8	WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores=less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores= less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity).Percent class time missed due to health problem calculated as: Q7\*100/(Q7+Q8) and score ranged from 0-100% where higher numbers=greater impairment and less productivity.
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period	Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8	WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, high scores=less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending (0-10 scale, high scores= less productivity); Q10=degree health affected productivity in regular daily activities (0-10 scale, high scores =less productivity). Percent impairment while in class was calculated as: 100\*Q9/10 and score ranged from 0-100% where higher numbers indicate greater impairment and less productivity.
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period	Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8	WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past7days.Questions:Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked;Q5=degree health affected productivity while working (0-10 scale, high scores=less productivity);Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale, high scores= less productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity).Percent overall class impairment due to health problem calculated as: 100\*{Q7/(Q7+Q8)+\[(1- Q7/(Q7+Q8))×(Q9/10)\]},score range:0-100%,higher numbers=greater impairment and less productivity.
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period	Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8	WPAI+CIQ: 10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions:Q1=currently employed;Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores=less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores= less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent activity impairment due to health problem calculated as: 100\*Q10/10, score ranged from 0-100%,higher numbers=greater impairment and less productivity.
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons;Q4=hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, high scores=less productivity);Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores=less productivity). Percent work time missed due to health problem calculated as: Q2\*100/(Q2+Q4) and score ranged from 0-100%,higher numbers=greater impairment and less productivity.
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions:Q1=currently employed; Q2=hours missed due to health problems; Q3=hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores=less productivity); Q6=classes attended in academic setting or not; Q7=hours missed due to health problems; Q8=hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores= less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent impairment while working due to health problem calculated as: 100\*Q5/10 score ranged from 0-100%,higher numbers=greater impairment and less productivity.
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked;Q5=degree health affected productivity while working(0-10 scale, high scores=less productivity);Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale, high scores= less productivity);Q10=degree health affected productivity: regular daily activities(0-10 scale, high scores =less productivity). Percent overall impairment while working due to health problem calculated as:100\*{Q2/(Q2+Q4)+\[(1- Q2/(Q2+Q4))×(Q5/10)\]}, score ranged: 0-100%, high numbers=greater impairment and less productivity.
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working(0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores= less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent class time missed due to health problem calculated as: Q7\*100/(Q7+Q8) and score ranged from 0-100% where higher numbers=greater impairment and less productivity.
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	WPAI+CIQ: 10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, high scores=less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities (0-10 scale, high scores =less productivity). Percent impairment while in class was calculated as: 100\*Q9/10 and score ranged from 0-100% where higher numbers indicate greater impairment and less productivity.
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	WPAI+CIQ: 10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities (0-10 scale, high scores =less productivity). Percent overall class impairment due to health problem calculated as: 100\*{Q7/(Q7+Q8)+\[(1- Q7/(Q7+Q8))×(Q9/10)\]}, score range:0-100%, higher numbers=greater impairment and less productivity.
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores=less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores= less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent activity impairment due to health problem calculated as: 100\*Q10/10, score ranged from 0-100%,higher numbers=greater impairment and less productivity.
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were: Q1=currently employed; Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5= degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent work time missed due to health problem calculated as: Q2\*100/(Q2+Q4) and score ranged from 0-100%, higher numbers=greater impairment and less productivity.
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	WPAI+CIQ: 10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=hours missed due to health problems; Q3=hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=hours missed due to health problems; Q8=hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent impairment while working due to health problem calculated as: 100\*Q5/10 score ranged from 0-100%, higher numbers=greater impairment and less productivity.
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	WPAI+CIQ: 10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending (0-10 scale, high scores = less productivity); Q10=degree health affected productivity: regular daily activities(0-10 scale, high scores =less productivity). Percent overall impairment while working due to health problem calculated as:100\*{Q2/(Q2+Q4)+\[(1- Q2/(Q2+Q4))×(Q5/10)\]}, score ranged:0-100%, high numbers=greater impairment and less productivity.
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working(0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent class time missed due to health problem calculated as: Q7\*100/(Q7+Q8) and score ranged from 0-100% where higher numbers=greater impairment and less productivity.
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending (0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent impairment while in class was calculated as: 100\*Q9/10 and score ranged from 0-100% where higher numbers indicate greater impairment and less productivity.
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities (0-10 scale, high scores =less productivity). Percent overall class impairment due to health problem calculated as: 100\*{Q7/(Q7+Q8)+\[(1- Q7/(Q7+Q8))×(Q9/10)\]}, score range:0-100%,higher numbers=greater impairment and less productivity.
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending (0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent activity impairment due to health problem calculated as: 100\*Q10/10, score ranged from 0-100%,higher numbers=greater impairment and less productivity.
Number of Flare-Free Days During the DB Period	Up to maximum of 52 weeks	Flare - free days was the sum of the duration of flare-free maintenance during the DB maintenance period for each participant.
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Weeks 0, 4, 8 and 12	WPAI+CIQ: 10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were: Q1=currently employed; Q2=hours missed due to health problems; Q3=hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=hours missed due to health problems; Q8=hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities (0-10 scale, high scores =less productivity). Percent impairment while working due to health problem calculated as: 100\*Q5/10 score ranged from 0-100%, higher numbers=greater impairment and less productivity.
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Weeks 0, 4, 8 and 12	WPAI+CIQ: 10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working(0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending (0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent overall impairment while working due to health problem calculated as:100\*{Q2/(Q2+Q4)+\[(1- Q2/(Q2+Q4))×(Q5/10)\]}, score ranged:0-100%, high numbers=greater impairment and less productivity.
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Weeks 0, 4, 8 and 12	WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent class time missed due to health problem calculated as: Q7\*100/(Q7+Q8) and score ranged from 0-100% where higher numbers=greater impairment and less productivity.
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Weeks 0, 4, 8 and 12	WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions:Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent impairment while in class was calculated as: 100\*Q9/10 and score ranged from 0-100% where higher numbers indicate greater impairment and less productivity.
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Weeks 0, 4, 8 and 12	WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending (0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent overall class impairment due to health problem calculated as: 100\*{Q7/(Q7+Q8)+\[(1- Q7/(Q7+Q8))×(Q9/10)\]}, score range:0-100%, higher numbers=greater impairment and less productivity.
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Weeks 0, 4, 8 and 12	WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent activity impairment due to health problem calculated as: 100\*Q10/10, scores ranged from 0-100%,higher numbers=greater impairment and less productivity.
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale (HADS): OL Run-in Period	Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8	HADS was a validated 14-item questionnaire to assess states of anxiety and depression over the past week. HADS consisted of 2 subscales: HADS-anxiety (HADS-A) and HADS-depression (HADS-D), each of which comprised of 7 items. Each item was rated on a 4-point scale, with scores ranging from 0 to 3, where higher scores indicated more anxiety/depression symptoms. HADS-A assessed state of generalized anxiety. HADS-A total score = sum of all 7 items with score ranging from 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicated greater severity of anxiety. HADS-D assessed the state of lost interest and diminished pleasure response. HADS-D total score = sum of all 7 items with score ranging from 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicated greater severity of depression symptoms.
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period	Baseline (last observation up to and including randomization day), Week 8, 16, 32 and end of treatment [Week 52]	HADS was a validated 14-item questionnaire to assess states of anxiety and depression over the past week. HADS consisted of 2 subscales: HADS-A and HADS-D, each of which comprised of 7 items. Each item was rated on a 4-point scale, with scores ranging from 0 to 3, where higher scores indicated more anxiety/depression symptoms. HADS-A assessed state of generalized anxiety. HADS-A total score = sum of all 7 items with score ranging from 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicated greater severity of anxiety. HADS-D assessed the state of lost interest and diminished pleasure response. HADS-D total score = sum of all 7 items with score ranging from 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicated greater severity of depression symptoms.
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Period	Weeks 0, 4, 8 and 12	HADS was a validated 14-item questionnaire to assess states of anxiety and depression over the past week. HADS consisted of 2 subscales: HADS-A and HADS-D, each of which comprised of 7 items. Each item was rated on a 4-point scale, with scores ranging from 0 to 3, where higher scores indicated more anxiety/depression symptoms. HADS-A assessed state of generalized anxiety. HADS-A total score = sum of all 7 items with score ranging from 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicated greater severity of anxiety. HADS-D assessed the state of lost interest and diminished pleasure response. HADS-D total score = sum of all 7 items with score ranging from 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicated greater severity of depression symptoms.
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Free Period	Baseline (last observation up to and including the randomization day of DB period), Weeks 8, 16 and 32	HADS was a validated 14-item questionnaire to assess states of anxiety and depression over the past week. HADS consisted of 2 subscales: HADS-A and HADS-D, each of which comprised of 7 items. Each item was rated on a 4-point scale, with scores ranging from 0 to 3, where higher scores indicated more anxiety/depression symptoms. HADS-A assessed state of generalized anxiety. HADS-A total score = sum of all 7 items with score ranging from 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicated greater severity of anxiety. HADS-D assessed the state of lost interest and diminished pleasure response. HADS-D total score = sum of all 7 items with score ranging from 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicated greater severity of depression symptoms.
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Weeks 0, 4, 8 and 12	WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending (0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities (0-10 scale, high scores=less productivity). Percent work time missed due to health problem calculated as: Q2\*100/(Q2+Q4) and score ranged from 0-100%, higher numbers=greater impairment and less productivity.
Number of Flares During the DB Period	Up to maximum of 52 weeks	Flare was defined as an ISGA score of \>=2. The ISGA is a 5-point scale (range 0 to 4), reflecting a global assessment of AD severity based on erythema, induration/papulation, and oozing/crusting. ISGA score of 2: mild (faint pink erythema with mild induration/papulation and no oozing/crusting) 3: moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting) and 4: severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting).

Countries

Australia, Canada, China, Israel, Turkey (Türkiye), United States

Participant flow

Pre-assignment details

A total of 620 participants signed the informed consent form and were enrolled in the study. 78 participants were screen failures who did not meet eligibility criteria. 542 participants were not screen failures, of which only 497 were assigned to study treatment.

Participants by arm

Arm	Count
Crisaborole 2% BID Participants with mild to moderate AD were administered crisaborole 2% ointment applied topically BID for maximum duration of up to 8 weeks in OL run-in period. Participants identified as responders during the OL period were randomized to receive vehicle or crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period.	497
Total	497

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Double Blind Period (up to 52 Weeks)	Adverse Event	0	3	1
Double Blind Period (up to 52 Weeks)	Lost to Follow-up	0	6	10
Double Blind Period (up to 52 Weeks)	Missing	0	2	5
Double Blind Period (up to 52 Weeks)	Other	0	29	18
Double Blind Period (up to 52 Weeks)	Physician Decision	0	0	2
Double Blind Period (up to 52 Weeks)	Pregnancy	0	2	0
Double Blind Period (up to 52 Weeks)	Protocol Violation	0	1	3
Double Blind Period (up to 52 Weeks)	Withdrawal by parent/guardian	0	8	7
Double Blind Period (up to 52 Weeks)	Withdrawal by Subject	0	6	11
Open Label Run-in Period (up to 8 Weeks)	Adverse Event	18	0	0
Open Label Run-in Period (up to 8 Weeks)	Failure to meet randomization criteria	152	0	0
Open Label Run-in Period (up to 8 Weeks)	Lost to Follow-up	14	0	0
Open Label Run-in Period (up to 8 Weeks)	Other	11	0	0
Open Label Run-in Period (up to 8 Weeks)	Physician Decision	3	0	0
Open Label Run-in Period (up to 8 Weeks)	Protocol Violation	3	0	0
Open Label Run-in Period (up to 8 Weeks)	Withdrawal by parent/guardian	18	0	0
Open Label Run-in Period (up to 8 Weeks)	Withdrawal by Subject	8	0	0

Baseline characteristics

Characteristic	Crisaborole 2% BID
Age, Continuous Crisaborole 2% BID	19.89 Years STANDARD_DEVIATION 18.443
Age, Continuous Crisaborole 2% QD	22.62 Years STANDARD_DEVIATION 20.175
Age, Continuous Vehicle QD	21.76 Years STANDARD_DEVIATION 20.373
Ethnicity (NIH/OMB) Crisaborole 2% BID Hispanic or Latino	54 Participants
Ethnicity (NIH/OMB) Crisaborole 2% BID Not Hispanic or Latino	426 Participants
Ethnicity (NIH/OMB) Crisaborole 2% BID Unknown or Not Reported	17 Participants
Ethnicity (NIH/OMB) Crisaborole 2% QD Hispanic or Latino	19 Participants
Ethnicity (NIH/OMB) Crisaborole 2% QD Not Hispanic or Latino	110 Participants
Ethnicity (NIH/OMB) Crisaborole 2% QD Unknown or Not Reported	6 Participants
Ethnicity (NIH/OMB) Vehicle QD Hispanic or Latino	10 Participants
Ethnicity (NIH/OMB) Vehicle QD Not Hispanic or Latino	120 Participants
Ethnicity (NIH/OMB) Vehicle QD Unknown or Not Reported	5 Participants
Race (NIH/OMB) Crisaborole 2% BID American Indian or Alaska Native	2 Participants
Race (NIH/OMB) Crisaborole 2% BID Asian	101 Participants
Race (NIH/OMB) Crisaborole 2% BID Black or African American	161 Participants
Race (NIH/OMB) Crisaborole 2% BID More than one race	18 Participants
Race (NIH/OMB) Crisaborole 2% BID Native Hawaiian or Other Pacific Islander	1 Participants
Race (NIH/OMB) Crisaborole 2% BID Unknown or Not Reported	10 Participants
Race (NIH/OMB) Crisaborole 2% BID White	204 Participants
Race (NIH/OMB) Crisaborole 2% QD American Indian or Alaska Native	2 Participants
Race (NIH/OMB) Crisaborole 2% QD Asian	28 Participants
Race (NIH/OMB) Crisaborole 2% QD Black or African American	42 Participants
Race (NIH/OMB) Crisaborole 2% QD More than one race	4 Participants
Race (NIH/OMB) Crisaborole 2% QD Native Hawaiian or Other Pacific Islander	1 Participants
Race (NIH/OMB) Crisaborole 2% QD Unknown or Not Reported	3 Participants
Race (NIH/OMB) Crisaborole 2% QD White	55 Participants
Race (NIH/OMB) Vehicle QD American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Vehicle QD Asian	27 Participants
Race (NIH/OMB) Vehicle QD Black or African American	47 Participants
Race (NIH/OMB) Vehicle QD More than one race	7 Participants
Race (NIH/OMB) Vehicle QD Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Vehicle QD Unknown or Not Reported	0 Participants
Race (NIH/OMB) Vehicle QD White	54 Participants
Sex: Female, Male Crisaborole 2% BID Female	283 Participants
Sex: Female, Male Crisaborole 2% BID Male	214 Participants
Sex: Female, Male Crisaborole 2% QD Female	71 Participants
Sex: Female, Male Crisaborole 2% QD Male	64 Participants
Sex: Female, Male Vehicle QD Female	76 Participants
Sex: Female, Male Vehicle QD Male	59 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk
deaths Total, all-cause mortality	0 / 497	0 / 135	0 / 135	0 / 89	0 / 78
other Total, other adverse events	78 / 497	30 / 135	27 / 135	22 / 89	14 / 78
serious Total, serious adverse events	3 / 497	3 / 135	2 / 135	1 / 89	1 / 78

Outcome results

Primary

Duration of Flare-Free Maintenance Until Onset of First-Flare During the Double Blind (DB) Period

The duration of flare-free maintenance was the time from randomization to the last Investigator's Static Global Assessment (ISGA) and was right censored, if an intercurrent event (eg, death, dropout, loss to follow up, or end of study) occurred before the first flare. When a flare occurred first, the duration of flare free maintenance was the time from randomization to the first flare and was not censored. Duration of flare free maintenance was estimated using the Kaplan-Meier method.

Time frame: From randomization to first flare or last ISGA assessment (up to 52 weeks)

Population: Evaluable-DB (Eval-DB) population included all randomized participants with success in ISGA (i.e., achieving a score of clear \[0\] or almost clear \[1\] with a \>=2 grade improvement from the run-in baseline) and Eczema Area Severity Index score (EASI50) criteria as responders at randomization and received at least 1 dose of study intervention in the DB period.

Arm	Measure	Value (MEDIAN)	Dispersion
Vehicle QD	Duration of Flare-Free Maintenance Until Onset of First-Flare During the Double Blind (DB) Period	30 Days	95% Confidence Interval 28
Crisaborole 2% QD	Duration of Flare-Free Maintenance Until Onset of First-Flare During the Double Blind (DB) Period	111 Days	95% Confidence Interval 56

p-value: 0.0034Log Rank

Primary

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started on or after the treatment period start date and before end of study (at least 28 days after last dose of study intervention).

Time frame: Crisaborole 2% BID: From start of study intervention in OL period up to 8 weeks ; Vehicle QD and crisaborole 2% QD: From start of study intervention in DB period up to 28 days after last dose of study intervention (maximum of 56 weeks)

Population: Safety population comprised of all participants who received at least 1 dose of study intervention during the study.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Vehicle QD	Number of Participants With Treatment Emergent Adverse Events (TEAEs)	109 Participants
Crisaborole 2% QD	Number of Participants With Treatment Emergent Adverse Events (TEAEs)	49 Participants
Crisaborole 2% QD	Number of Participants With Treatment Emergent Adverse Events (TEAEs)	36 Participants

Secondary

AD Skin Pain Scores for Participants >=12 Years of Age: DB Period

Participants 12 years of age or older were asked to assess their worst skin pain due to AD at the analysis time, with the question: 'AD skin pain right now' using the skin pain numerical rating scale (NRS). Skin pain NRS was a 11-point horizontal scale anchored at 0 and 10, with 0 representing no pain and 10 representing worst pain imaginable. Higher scores indicated worse pain.

Time frame: Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Week 20	1.0 Units on a scale	Standard Deviation 1.49
Vehicle QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Baseline	1.1 Units on a scale	Standard Deviation 1.34
Vehicle QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Week 36	1.1 Units on a scale	Standard Deviation 1.61
Vehicle QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Week 24	1.1 Units on a scale	Standard Deviation 1.52
Vehicle QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Week 48	1.3 Units on a scale	Standard Deviation 1.64
Vehicle QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Week 52	1.0 Units on a scale	Standard Deviation 1.62
Vehicle QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Week 32	1.0 Units on a scale	Standard Deviation 1.53
Vehicle QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Week 28	1.0 Units on a scale	Standard Deviation 1.54
Vehicle QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Week 44	1.1 Units on a scale	Standard Deviation 1.67
Vehicle QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Week 12	1.1 Units on a scale	Standard Deviation 1.69
Vehicle QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Week 8	1.0 Units on a scale	Standard Deviation 1.09
Vehicle QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Week 16	1.3 Units on a scale	Standard Deviation 1.9
Vehicle QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Week 4	1.1 Units on a scale	Standard Deviation 1.55
Vehicle QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Week 40	1.1 Units on a scale	Standard Deviation 1.49
Crisaborole 2% QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Week 12	0.9 Units on a scale	Standard Deviation 1.62
Crisaborole 2% QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Baseline	1.2 Units on a scale	Standard Deviation 1.74
Crisaborole 2% QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Week 4	0.7 Units on a scale	Standard Deviation 1.27
Crisaborole 2% QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Week 8	1.0 Units on a scale	Standard Deviation 1.59
Crisaborole 2% QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Week 16	1.1 Units on a scale	Standard Deviation 1.67
Crisaborole 2% QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Week 20	1.1 Units on a scale	Standard Deviation 1.81
Crisaborole 2% QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Week 48	0.9 Units on a scale	Standard Deviation 1.88
Crisaborole 2% QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Week 24	1.0 Units on a scale	Standard Deviation 1.82
Crisaborole 2% QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Week 28	1.0 Units on a scale	Standard Deviation 1.78
Crisaborole 2% QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Week 32	0.8 Units on a scale	Standard Deviation 1.71
Crisaborole 2% QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Week 36	0.9 Units on a scale	Standard Deviation 1.78
Crisaborole 2% QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Week 40	1.1 Units on a scale	Standard Deviation 1.95
Crisaborole 2% QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Week 44	1.1 Units on a scale	Standard Deviation 1.99
Crisaborole 2% QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Week 52	1.0 Units on a scale	Standard Deviation 1.99
Crisaborole 2% QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Week 48	1.6 Units on a scale	Standard Deviation 2
Crisaborole 2% QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Week 36	1.2 Units on a scale	Standard Deviation 1.66
Crisaborole 2% QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Week 16	1.2 Units on a scale	Standard Deviation 1.3
Crisaborole 2% QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Week 12	1.5 Units on a scale	Standard Deviation 1.8
Crisaborole 2% QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Week 40	1.5 Units on a scale	Standard Deviation 1.85
Crisaborole 2% QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Week 8	1.5 Units on a scale	Standard Deviation 2
Crisaborole 2% QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Week 52	1.1 Units on a scale	Standard Deviation 1.45
Crisaborole 2% QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Week 44	1.2 Units on a scale	Standard Deviation 1.82
Crisaborole 2% QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Week 28	1.8 Units on a scale	Standard Deviation 1.97
Crisaborole 2% QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Week 24	1.1 Units on a scale	Standard Deviation 1.53
Crisaborole 2% QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Week 4	1.6 Units on a scale	Standard Deviation 1.68
Crisaborole 2% QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Week 32	1.6 Units on a scale	Standard Deviation 1.76
Crisaborole 2% QD	AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	Week 20	1.8 Units on a scale	Standard Deviation 1.65

Secondary

AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period

Participants 12 years of age or older were asked to assess their worst skin pain due to AD at the analysis time, with the question: 'AD skin pain right now' using the skin pain NRS. Skin pain NRS was a 11-point horizontal scale anchored at 0 and 10, with 0 representing no pain and 10 representing worst pain imaginable. Higher scores indicated worse pain.

Time frame: Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period	Baseline	1.1 Units on a scale	Standard Deviation 1.34
Vehicle QD	AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period	Week 4	1.2 Units on a scale	Standard Deviation 1.58
Vehicle QD	AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period	Week 8	1.0 Units on a scale	Standard Deviation 1.16
Vehicle QD	AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period	Week 12	0.9 Units on a scale	Standard Deviation 1.17
Vehicle QD	AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period	Week 16	1.1 Units on a scale	Standard Deviation 1.28
Vehicle QD	AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period	Week 20	1.1 Units on a scale	Standard Deviation 1.18
Vehicle QD	AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period	Week 24	1.2 Units on a scale	Standard Deviation 1.36
Vehicle QD	AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period	Week 28	1.0 Units on a scale	Standard Deviation 1.35
Vehicle QD	AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period	Week 32	1.1 Units on a scale	Standard Deviation 1.41
Vehicle QD	AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period	Week 36	1.2 Units on a scale	Standard Deviation 1.44
Vehicle QD	AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period	Week 40	1.2 Units on a scale	Standard Deviation 1.43
Vehicle QD	AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period	Week 44	1.2 Units on a scale	Standard Deviation 1.48
Vehicle QD	AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period	Week 48	1.3 Units on a scale	Standard Deviation 1.43
Vehicle QD	AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period	Week 52	1.1 Units on a scale	Standard Deviation 1.46
Crisaborole 2% QD	AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period	Week 40	1.1 Units on a scale	Standard Deviation 2.21
Crisaborole 2% QD	AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period	Baseline	1.2 Units on a scale	Standard Deviation 1.74
Crisaborole 2% QD	AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period	Week 28	1.0 Units on a scale	Standard Deviation 2.04
Crisaborole 2% QD	AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period	Week 4	0.7 Units on a scale	Standard Deviation 1.3
Crisaborole 2% QD	AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period	Week 48	1.0 Units on a scale	Standard Deviation 2.28
Crisaborole 2% QD	AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period	Week 8	1.0 Units on a scale	Standard Deviation 1.65
Crisaborole 2% QD	AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period	Week 32	1.0 Units on a scale	Standard Deviation 2.06
Crisaborole 2% QD	AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period	Week 12	1.0 Units on a scale	Standard Deviation 1.75
Crisaborole 2% QD	AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period	Week 44	1.1 Units on a scale	Standard Deviation 2.37
Crisaborole 2% QD	AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period	Week 16	1.1 Units on a scale	Standard Deviation 1.83
Crisaborole 2% QD	AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period	Week 36	1.0 Units on a scale	Standard Deviation 2.08
Crisaborole 2% QD	AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period	Week 20	1.1 Units on a scale	Standard Deviation 2.02
Crisaborole 2% QD	AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period	Week 52	1.0 Units on a scale	Standard Deviation 2.32
Crisaborole 2% QD	AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period	Week 24	1.0 Units on a scale	Standard Deviation 1.97

Secondary

AD Skin Pain Scores for Participants >=12 Years of Age: First Flare Period

Time frame: Weeks 0, 4, 8, 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	AD Skin Pain Scores for Participants >=12 Years of Age: First Flare Period	Week 0	1.2 Units on a scale	Standard Deviation 1.26
Vehicle QD	AD Skin Pain Scores for Participants >=12 Years of Age: First Flare Period	Week 4	1.4 Units on a scale	Standard Deviation 1.75
Vehicle QD	AD Skin Pain Scores for Participants >=12 Years of Age: First Flare Period	Week 8	1.3 Units on a scale	Standard Deviation 1.53
Vehicle QD	AD Skin Pain Scores for Participants >=12 Years of Age: First Flare Period	Week 12	2.0 Units on a scale	Standard Deviation 1.66
Crisaborole 2% QD	AD Skin Pain Scores for Participants >=12 Years of Age: First Flare Period	Week 12	2.3 Units on a scale	Standard Deviation 2.05
Crisaborole 2% QD	AD Skin Pain Scores for Participants >=12 Years of Age: First Flare Period	Week 0	2.2 Units on a scale	Standard Deviation 2.01
Crisaborole 2% QD	AD Skin Pain Scores for Participants >=12 Years of Age: First Flare Period	Week 8	2.3 Units on a scale	Standard Deviation 2.15
Crisaborole 2% QD	AD Skin Pain Scores for Participants >=12 Years of Age: First Flare Period	Week 4	1.7 Units on a scale	Standard Deviation 1.94

Secondary

AD Skin Pain Scores for Participants >=12 Years of Age: OL Run-in Period

Time frame: Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8

Population: Eval-OL population included all participants that received at least 1 dose of study intervention in the OL period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	AD Skin Pain Scores for Participants >=12 Years of Age: OL Run-in Period	Baseline	2.6 Units on a scale	Standard Deviation 2.6
Vehicle QD	AD Skin Pain Scores for Participants >=12 Years of Age: OL Run-in Period	Week 2	2.0 Units on a scale	Standard Deviation 1.96
Vehicle QD	AD Skin Pain Scores for Participants >=12 Years of Age: OL Run-in Period	Week 4	1.9 Units on a scale	Standard Deviation 2.03
Vehicle QD	AD Skin Pain Scores for Participants >=12 Years of Age: OL Run-in Period	Week 6	1.8 Units on a scale	Standard Deviation 2.08
Vehicle QD	AD Skin Pain Scores for Participants >=12 Years of Age: OL Run-in Period	Week 8	1.7 Units on a scale	Standard Deviation 2.06

Secondary

Change From Baseline in ISGA Scores at Weeks 0, 4, 8 and 12 for First Flare Treatment Period

ISGA:5-point global assessment scale, used to characterize overall disease severity across all treatable AD lesions (excluding scalp). Score ranged:0 to 4,where 0=clear(minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1=almost clear(trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2=mild(faint pink erythema with mild induration/papulation and no oozing/crusting), 3=moderate(pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4=severe(deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicate greater severity of AD. The period for which OL crisaborole 2% ointment BID was initiated for treatment of flare developed during DB maintenance until resumption of DB treatment was defined as flare treatment period.

Time frame: Baseline (last observation up to and including the randomization day), Weeks 0, 4, 8 and 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Change From Baseline in ISGA Scores at Weeks 0, 4, 8 and 12 for First Flare Treatment Period	Change at Week 0	1.8 Units on a scale	Standard Deviation 0.57
Vehicle QD	Change From Baseline in ISGA Scores at Weeks 0, 4, 8 and 12 for First Flare Treatment Period	Change at Week 4	1.5 Units on a scale	Standard Deviation 0.54
Vehicle QD	Change From Baseline in ISGA Scores at Weeks 0, 4, 8 and 12 for First Flare Treatment Period	Change at Week 8	1.3 Units on a scale	Standard Deviation 0.47
Vehicle QD	Change From Baseline in ISGA Scores at Weeks 0, 4, 8 and 12 for First Flare Treatment Period	Change at Week 12	1.5 Units on a scale	Standard Deviation 0.53
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 0, 4, 8 and 12 for First Flare Treatment Period	Change at Week 12	1.6 Units on a scale	Standard Deviation 0.67
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 0, 4, 8 and 12 for First Flare Treatment Period	Change at Week 0	1.7 Units on a scale	Standard Deviation 0.49
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 0, 4, 8 and 12 for First Flare Treatment Period	Change at Week 8	1.6 Units on a scale	Standard Deviation 0.74
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 0, 4, 8 and 12 for First Flare Treatment Period	Change at Week 4	1.5 Units on a scale	Standard Deviation 0.55

Secondary

Change From Baseline in ISGA Scores at Weeks 2, 4, 6 and 8 for OL run-in Period

ISGA is a 5- point global assessment scale, used to characterize overall disease severity across all treatable AD lesions (excluding the scalp). Score ranged from 0 to 4: where 0= clear(minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicate greater severity of AD.

Time frame: Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8

Population: Eval-OL population included all participants that received at least 1 dose of study intervention in the OL period.

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Change From Baseline in ISGA Scores at Weeks 2, 4, 6 and 8 for OL run-in Period	Baseline	2.7 Units on a scale	Standard Deviation 0.48
Vehicle QD	Change From Baseline in ISGA Scores at Weeks 2, 4, 6 and 8 for OL run-in Period	Change at Week 2	-0.5 Units on a scale	Standard Deviation 0.69
Vehicle QD	Change From Baseline in ISGA Scores at Weeks 2, 4, 6 and 8 for OL run-in Period	Change at Week 4	-0.7 Units on a scale	Standard Deviation 0.84
Vehicle QD	Change From Baseline in ISGA Scores at Weeks 2, 4, 6 and 8 for OL run-in Period	Change at Week 6	-0.9 Units on a scale	Standard Deviation 0.93
Vehicle QD	Change From Baseline in ISGA Scores at Weeks 2, 4, 6 and 8 for OL run-in Period	Change at Week 8	-1.2 Units on a scale	Standard Deviation 1.04

Secondary

Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period

Time frame: Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Change at Week 20	0.3 Units on a scale	Standard Deviation 0.75
Vehicle QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Change at Week 4	0.2 Units on a scale	Standard Deviation 0.52
Vehicle QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Change at Week 40	0.0 Units on a scale	Standard Deviation 0.57
Vehicle QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Change at Week 24	0.0 Units on a scale	Standard Deviation 0.67
Vehicle QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Change at Week 48	0.1 Units on a scale	Standard Deviation 0.65
Vehicle QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Change at Week 36	0.4 Units on a scale	Standard Deviation 0.74
Vehicle QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Change at Week 28	0.3 Units on a scale	Standard Deviation 0.45
Vehicle QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Change at Week 12	0.1 Units on a scale	Standard Deviation 0.52
Vehicle QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Change at Week 32	-0.0 Units on a scale	Standard Deviation 0.6
Vehicle QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Change at Week 52	0.0 Units on a scale	Standard Deviation 0.66
Vehicle QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Change at Week 44	-0.1 Units on a scale	Standard Deviation 0.64
Vehicle QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Change at Week 16	0.2 Units on a scale	Standard Deviation 0.46
Vehicle QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Change at Week 8	0.2 Units on a scale	Standard Deviation 0.5
Vehicle QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Baseline	0.6 Units on a scale	Standard Deviation 0.5
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Change at Week 40	0.0 Units on a scale	Standard Deviation 0.59
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Baseline	0.6 Units on a scale	Standard Deviation 0.49
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Change at Week 4	0.1 Units on a scale	Standard Deviation 0.49
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Change at Week 8	0.1 Units on a scale	Standard Deviation 0.58
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Change at Week 12	0.0 Units on a scale	Standard Deviation 0.54
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Change at Week 16	-0.0 Units on a scale	Standard Deviation 0.53
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Change at Week 20	0.2 Units on a scale	Standard Deviation 0.69
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Change at Week 24	-0.1 Units on a scale	Standard Deviation 0.56
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Change at Week 28	0.2 Units on a scale	Standard Deviation 0.41
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Change at Week 32	-0.1 Units on a scale	Standard Deviation 0.53
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Change at Week 36	0.0 Units on a scale	Standard Deviation 0
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Change at Week 44	0.3 Units on a scale	Standard Deviation 0.71
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Change at Week 48	-0.0 Units on a scale	Standard Deviation 0.63
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Change at Week 52	-0.0 Units on a scale	Standard Deviation 0.57
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Change at Week 36	1.5 Units on a scale	Standard Deviation 0.51
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Change at Week 20	1.8 Units on a scale	Standard Deviation 0.68
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Change at Week 16	1.6 Units on a scale	Standard Deviation 0.6
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Change at Week 40	1.6 Units on a scale	Standard Deviation 0.67
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Change at Week 12	1.5 Units on a scale	Standard Deviation 0.58
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Change at Week 4	1.7 Units on a scale	Standard Deviation 0.53
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Change at Week 44	1.8 Units on a scale	Standard Deviation 0.68
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Change at Week 8	1.5 Units on a scale	Standard Deviation 0.55
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Change at Week 28	1.6 Units on a scale	Standard Deviation 0.64
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Change at Week 52	1.6 Units on a scale	Standard Deviation 0.57
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Change at Week 32	1.7 Units on a scale	Standard Deviation 0.53
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Change at Week 24	1.5 Units on a scale	Standard Deviation 0.61
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period	Change at Week 48	1.6 Units on a scale	Standard Deviation 0.68

Secondary

Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period

Time frame: Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period	Baseline	0.6 Units on a scale	Standard Deviation 0.5
Vehicle QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period	Change at Week 4	0.2 Units on a scale	Standard Deviation 0.54
Vehicle QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period	Change at Week 8	0.2 Units on a scale	Standard Deviation 0.5
Vehicle QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period	Change at Week 12	0.1 Units on a scale	Standard Deviation 0.55
Vehicle QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period	Change at Week 16	0.2 Units on a scale	Standard Deviation 0.43
Vehicle QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period	Change at Week 20	0.0 Units on a scale	—
Vehicle QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period	Change at Week 24	0.0 Units on a scale	Standard Deviation 0.63
Vehicle QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period	Change at Week 28	0.5 Units on a scale	Standard Deviation 0.71
Vehicle QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period	Change at Week 32	-0.1 Units on a scale	Standard Deviation 0.64
Vehicle QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period	Change at Week 36	0.0 Units on a scale	—
Vehicle QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period	Change at Week 40	0.0 Units on a scale	Standard Deviation 0.6
Vehicle QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period	Change at Week 44	0.0 Units on a scale	Standard Deviation 0
Vehicle QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period	Change at Week 48	0.0 Units on a scale	Standard Deviation 0.66
Vehicle QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period	Change at Week 52	0.0 Units on a scale	Standard Deviation 0.62
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period	Change at Week 40	-0.1 Units on a scale	Standard Deviation 0.66
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period	Baseline	0.6 Units on a scale	Standard Deviation 0.49
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period	Change at Week 28	0.0 Units on a scale	Standard Deviation 0
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period	Change at Week 4	0.1 Units on a scale	Standard Deviation 0.49
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period	Change at Week 48	-0.1 Units on a scale	Standard Deviation 0.64
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period	Change at Week 8	0.1 Units on a scale	Standard Deviation 0.6
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period	Change at Week 32	-0.1 Units on a scale	Standard Deviation 0.53
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period	Change at Week 12	-0.1 Units on a scale	Standard Deviation 0.54
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period	Change at Week 44	0.7 Units on a scale	Standard Deviation 0.58
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period	Change at Week 16	0.0 Units on a scale	Standard Deviation 0.52
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period	Change at Week 36	0.0 Units on a scale	—
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period	Change at Week 20	-0.4 Units on a scale	Standard Deviation 0.55
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period	Change at Week 52	-0.0 Units on a scale	Standard Deviation 0.61
Crisaborole 2% QD	Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period	Change at Week 24	-0.1 Units on a scale	Standard Deviation 0.55

Secondary

Change From Baseline in Most Commonly Affected Atopic Dermatitis (AD) % BSA: DB Period

The investigators were required to draw the skin areas affected by AD for each participant in a body map and the most commonly affected BSA was documented.

Time frame: Baseline (last observation up to and including the randomization day), Weeks 24 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Change From Baseline in Most Commonly Affected Atopic Dermatitis (AD) % BSA: DB Period	Baseline	14.28 Percentage BSA affected	Standard Deviation 13.957
Vehicle QD	Change From Baseline in Most Commonly Affected Atopic Dermatitis (AD) % BSA: DB Period	Change at Week 24	2.29 Percentage BSA affected	Standard Deviation 11.579
Vehicle QD	Change From Baseline in Most Commonly Affected Atopic Dermatitis (AD) % BSA: DB Period	Change at Week 52	-3.46 Percentage BSA affected	Standard Deviation 10.536
Crisaborole 2% QD	Change From Baseline in Most Commonly Affected Atopic Dermatitis (AD) % BSA: DB Period	Change at Week 52	-4.95 Percentage BSA affected	Standard Deviation 7.731
Crisaborole 2% QD	Change From Baseline in Most Commonly Affected Atopic Dermatitis (AD) % BSA: DB Period	Change at Week 24	-0.20 Percentage BSA affected	Standard Deviation 3.919
Crisaborole 2% QD	Change From Baseline in Most Commonly Affected Atopic Dermatitis (AD) % BSA: DB Period	Baseline	10.77 Percentage BSA affected	Standard Deviation 9.834
Crisaborole 2% QD	Change From Baseline in Most Commonly Affected Atopic Dermatitis (AD) % BSA: DB Period	Change at Week 52	0.71 Percentage BSA affected	Standard Deviation 16.649
Crisaborole 2% QD	Change From Baseline in Most Commonly Affected Atopic Dermatitis (AD) % BSA: DB Period	Change at Week 24	1.75 Percentage BSA affected	Standard Deviation 3.304

Secondary

Change From Baseline in Treatable %BSA: DB Period

The extent (%) to which a body region was involved with AD was determined using handprint method. Four body regions evaluated: head and neck (hn), upper limbs (ul), trunk (tr) (including axillae) and lower limbs (ll) (including buttocks). Total number of handprints=10 for hn, 20 for ul, 30 for tr, 40 for ll in participants aged \>=8 years; 20 for hn, 20 for ul, 30 for tr, 30 for ll in participants aged 3 months to 7 years. Surface area of body region equivalent to 1 handprint: 10% for hn, 5% for ul, 3.33% for tr, 2.5% for ll in participants aged \>=8 years; 5% for hn, 5% for ul, 3.33% for tr, 3.33% for ll in participants aged 3 months to 7 years. % BSA for a body region= total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall % BSA for an individual=sum of % BSA across all 4 body regions and ranged from 0 to 100%, with higher values representing greater extent of BSA involvement with AD.

Time frame: Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Change From Baseline in Treatable %BSA: DB Period	Change at Week 20	-1.29 Percentage BSA	Standard Deviation 5.363
Vehicle QD	Change From Baseline in Treatable %BSA: DB Period	Change at Week 4	1.16 Percentage BSA	Standard Deviation 4.391
Vehicle QD	Change From Baseline in Treatable %BSA: DB Period	Change at Week 40	0.02 Percentage BSA	Standard Deviation 6.752
Vehicle QD	Change From Baseline in Treatable %BSA: DB Period	Change at Week 24	2.42 Percentage BSA	Standard Deviation 9.213
Vehicle QD	Change From Baseline in Treatable %BSA: DB Period	Change at Week 48	-0.37 Percentage BSA	Standard Deviation 7.134
Vehicle QD	Change From Baseline in Treatable %BSA: DB Period	Change at Week 36	0.44 Percentage BSA	Standard Deviation 1.917
Vehicle QD	Change From Baseline in Treatable %BSA: DB Period	Change at Week 28	-0.30 Percentage BSA	Standard Deviation 6.323
Vehicle QD	Change From Baseline in Treatable %BSA: DB Period	Change at Week 12	1.20 Percentage BSA	Standard Deviation 6.821
Vehicle QD	Change From Baseline in Treatable %BSA: DB Period	Change at Week 32	0.33 Percentage BSA	Standard Deviation 7.623
Vehicle QD	Change From Baseline in Treatable %BSA: DB Period	Change at Week 52	-1.23 Percentage BSA	Standard Deviation 5.531
Vehicle QD	Change From Baseline in Treatable %BSA: DB Period	Change at Week 44	-2.56 Percentage BSA	Standard Deviation 4.889
Vehicle QD	Change From Baseline in Treatable %BSA: DB Period	Change at Week 16	1.25 Percentage BSA	Standard Deviation 5.623
Vehicle QD	Change From Baseline in Treatable %BSA: DB Period	Change at Week 8	0.59 Percentage BSA	Standard Deviation 6.202
Vehicle QD	Change From Baseline in Treatable %BSA: DB Period	Baseline	5.25 Percentage BSA	Standard Deviation 9.588
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: DB Period	Change at Week 40	0.89 Percentage BSA	Standard Deviation 6.097
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: DB Period	Baseline	5.22 Percentage BSA	Standard Deviation 7.17
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: DB Period	Change at Week 4	0.52 Percentage BSA	Standard Deviation 5.164
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: DB Period	Change at Week 8	-0.19 Percentage BSA	Standard Deviation 6.659
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: DB Period	Change at Week 12	0.26 Percentage BSA	Standard Deviation 6.093
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: DB Period	Change at Week 16	0.58 Percentage BSA	Standard Deviation 5.848
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: DB Period	Change at Week 20	1.38 Percentage BSA	Standard Deviation 6.846
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: DB Period	Change at Week 24	2.15 Percentage BSA	Standard Deviation 11.217
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: DB Period	Change at Week 28	-1.25 Percentage BSA	Standard Deviation 5.906
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: DB Period	Change at Week 32	0.84 Percentage BSA	Standard Deviation 5.971
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: DB Period	Change at Week 36	2.50 Percentage BSA	Standard Deviation 3.623
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: DB Period	Change at Week 44	0.57 Percentage BSA	Standard Deviation 2.524
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: DB Period	Change at Week 48	0.48 Percentage BSA	Standard Deviation 6.295
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: DB Period	Change at Week 52	-1.91 Percentage BSA	Standard Deviation 5.411
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: DB Period	Change at Week 36	3.36 Percentage BSA	Standard Deviation 6.603
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: DB Period	Change at Week 20	7.45 Percentage BSA	Standard Deviation 13.678
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: DB Period	Change at Week 16	5.33 Percentage BSA	Standard Deviation 9.369
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: DB Period	Change at Week 40	3.50 Percentage BSA	Standard Deviation 8.292
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: DB Period	Change at Week 12	6.17 Percentage BSA	Standard Deviation 9.801
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: DB Period	Change at Week 4	6.25 Percentage BSA	Standard Deviation 8.208
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: DB Period	Change at Week 44	5.71 Percentage BSA	Standard Deviation 7.559
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: DB Period	Change at Week 8	4.65 Percentage BSA	Standard Deviation 8.568
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: DB Period	Change at Week 28	7.22 Percentage BSA	Standard Deviation 9.389
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: DB Period	Change at Week 52	4.20 Percentage BSA	Standard Deviation 8.835
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: DB Period	Change at Week 32	6.36 Percentage BSA	Standard Deviation 11.286
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: DB Period	Change at Week 24	4.79 Percentage BSA	Standard Deviation 7.483
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: DB Period	Change at Week 48	4.05 Percentage BSA	Standard Deviation 8.689

Secondary

Change From Baseline in Treatable %BSA: First Flare Free Period

Time frame: Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Change From Baseline in Treatable %BSA: First Flare Free Period	Baseline	5.25 Percentage BSA	Standard Deviation 9.588
Vehicle QD	Change From Baseline in Treatable %BSA: First Flare Free Period	Change at Week 4	1.20 Percentage BSA	Standard Deviation 4.487
Vehicle QD	Change From Baseline in Treatable %BSA: First Flare Free Period	Change at Week 8	0.21 Percentage BSA	Standard Deviation 7.661
Vehicle QD	Change From Baseline in Treatable %BSA: First Flare Free Period	Change at Week 12	0.96 Percentage BSA	Standard Deviation 6.161
Vehicle QD	Change From Baseline in Treatable %BSA: First Flare Free Period	Change at Week 16	1.05 Percentage BSA	Standard Deviation 5.929
Vehicle QD	Change From Baseline in Treatable %BSA: First Flare Free Period	Change at Week 20	5.00 Percentage BSA	—
Vehicle QD	Change From Baseline in Treatable %BSA: First Flare Free Period	Change at Week 24	2.46 Percentage BSA	Standard Deviation 8.669
Vehicle QD	Change From Baseline in Treatable %BSA: First Flare Free Period	Change at Week 28	-1.50 Percentage BSA	Standard Deviation 2.121
Vehicle QD	Change From Baseline in Treatable %BSA: First Flare Free Period	Change at Week 32	0.40 Percentage BSA	Standard Deviation 8.581
Vehicle QD	Change From Baseline in Treatable %BSA: First Flare Free Period	Change at Week 36	-2.00 Percentage BSA	—
Vehicle QD	Change From Baseline in Treatable %BSA: First Flare Free Period	Change at Week 40	-0.46 Percentage BSA	Standard Deviation 7.881
Vehicle QD	Change From Baseline in Treatable %BSA: First Flare Free Period	Change at Week 44	-3.25 Percentage BSA	Standard Deviation 4.596
Vehicle QD	Change From Baseline in Treatable %BSA: First Flare Free Period	Change at Week 48	-0.85 Percentage BSA	Standard Deviation 7.724
Vehicle QD	Change From Baseline in Treatable %BSA: First Flare Free Period	Change at Week 52	-1.50 Percentage BSA	Standard Deviation 7.365
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: First Flare Free Period	Change at Week 40	1.17 Percentage BSA	Standard Deviation 6.153
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: First Flare Free Period	Baseline	5.22 Percentage BSA	Standard Deviation 7.17
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: First Flare Free Period	Change at Week 28	-3.00 Percentage BSA	Standard Deviation 12.728
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: First Flare Free Period	Change at Week 4	0.53 Percentage BSA	Standard Deviation 5.196
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: First Flare Free Period	Change at Week 48	1.14 Percentage BSA	Standard Deviation 6.959
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: First Flare Free Period	Change at Week 8	-0.10 Percentage BSA	Standard Deviation 6.954
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: First Flare Free Period	Change at Week 32	0.91 Percentage BSA	Standard Deviation 5.669
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: First Flare Free Period	Change at Week 12	0.05 Percentage BSA	Standard Deviation 6.309
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: First Flare Free Period	Change at Week 44	2.33 Percentage BSA	Standard Deviation 3.215
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: First Flare Free Period	Change at Week 16	0.28 Percentage BSA	Standard Deviation 5.891
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: First Flare Free Period	Change at Week 36	0.00 Percentage BSA	—
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: First Flare Free Period	Change at Week 20	-0.60 Percentage BSA	Standard Deviation 9.659
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: First Flare Free Period	Change at Week 52	-1.47 Percentage BSA	Standard Deviation 5.232
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: First Flare Free Period	Change at Week 24	3.09 Percentage BSA	Standard Deviation 13.575

Secondary

Change From Baseline in Treatable %BSA: First Flare Period

Time frame: Baseline (last observation up to and including the randomization day), Weeks 0, 4, 8 and 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Change From Baseline in Treatable %BSA: First Flare Period	Change at Week 0	8.27 Percentage BSA	Standard Deviation 12.154
Vehicle QD	Change From Baseline in Treatable %BSA: First Flare Period	Change at Week 4	6.92 Percentage BSA	Standard Deviation 9.704
Vehicle QD	Change From Baseline in Treatable %BSA: First Flare Period	Change at Week 8	4.95 Percentage BSA	Standard Deviation 11.642
Vehicle QD	Change From Baseline in Treatable %BSA: First Flare Period	Change at Week 12	5.75 Percentage BSA	Standard Deviation 10.499
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: First Flare Period	Change at Week 12	3.39 Percentage BSA	Standard Deviation 5.328
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: First Flare Period	Change at Week 0	4.68 Percentage BSA	Standard Deviation 6.304
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: First Flare Period	Change at Week 8	3.56 Percentage BSA	Standard Deviation 6.646
Crisaborole 2% QD	Change From Baseline in Treatable %BSA: First Flare Period	Change at Week 4	4.17 Percentage BSA	Standard Deviation 6.884

Secondary

Change From Baseline in Treatable Percent Body Surface Area (% BSA): OL Run-in Period

Time frame: Baseline (last observation up to and including the randomization day) Weeks 2, 4, 6 and 8

Population: Eval-OL population included all participants that received at least 1 dose of study intervention in the OL period.

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Change From Baseline in Treatable Percent Body Surface Area (% BSA): OL Run-in Period	Baseline	19.61 Percentage BSA	Standard Deviation 16.807
Vehicle QD	Change From Baseline in Treatable Percent Body Surface Area (% BSA): OL Run-in Period	Change at Week 2	-3.86 Percentage BSA	Standard Deviation 8.313
Vehicle QD	Change From Baseline in Treatable Percent Body Surface Area (% BSA): OL Run-in Period	Change at Week 4	-5.09 Percentage BSA	Standard Deviation 10.061
Vehicle QD	Change From Baseline in Treatable Percent Body Surface Area (% BSA): OL Run-in Period	Change at Week 6	-6.42 Percentage BSA	Standard Deviation 11.398
Vehicle QD	Change From Baseline in Treatable Percent Body Surface Area (% BSA): OL Run-in Period	Change at Week 8	-7.35 Percentage BSA	Standard Deviation 12.301

Secondary

Duration (Days) of Flare Period

Duration of flare period was average duration calculated from sum of durations divided by number of flares for each participant.

Time frame: Up to 52 weeks

Arm	Measure	Value (MEAN)	Dispersion
Vehicle QD	Duration (Days) of Flare Period	54.2 Days	Standard Deviation 28.77
Crisaborole 2% QD	Duration (Days) of Flare Period	55.3 Days	Standard Deviation 35.73

Secondary

Duration of Maintenance of >=50% Reduction in Eczema Area and Severity Index (EASI) Total Score Until Onset of First Flare During the DB Period

EASI assessed severity of AD, based on severity of lesion clinical signs (erythema \[E\], induration/papulation \[I\], excoriation \[Ex\], lichenification \[L\]) and % body surface area (BSA) affected. Each of clinical signs scored separately for each of 4 body regions (head and neck \[h\], upper limbs \[u\], trunk \[t\] \[including axillae and groin\], lower limbs \[l\] \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score (A) according to %BSA with AD: 0 (0%), 1(\>0 to \<10%), 2(10 to \<30%), 3(30 to \<50%), 4(50 to \<70%), 5(70 to \<90%), 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh + Ih + Exh + Lh) + 0.2\*Au\*(Eu + Iu + ExU + Lu) + 0.3\*At\*(Et +It + Ext + Lt) + 0.4\*Al\*(El + Il + Exl + Ll). Total EASI score ranged from 0.0 to 72.0, higher score = greater severity of AD. EASI response maintenance = score that does not lose more than 50% of achieved reduction from Day1/Baseline run-in EASI score.

Time frame: From randomization to loss of EASI response or onset of first flare or the last EASI assessment (up to maximum of 52 weeks)

Arm	Measure	Value (MEDIAN)
Vehicle QD	Duration of Maintenance of >=50% Reduction in Eczema Area and Severity Index (EASI) Total Score Until Onset of First Flare During the DB Period	198 Days
Crisaborole 2% QD	Duration of Maintenance of >=50% Reduction in Eczema Area and Severity Index (EASI) Total Score Until Onset of First Flare During the DB Period	NA Days

p-value: 0.1159Log Rank

Secondary

Duration of Maintenance of Dermatology Life Quality Index (DLQI) Response Until Onset of First Flare During the DB Period

Duration of DLQI maintenance=time from randomization to loss of DLQI response during 52-week DB period for responders at randomization. If event(e.g., death, first flare\[ISGA \>=2\], lost to follow up or end of study) occurred before loss of DLQI response, duration of maintenance of DLQI response=time from randomization to last assessment and censored. Responders=participants with success in ISGA,EASI50 criteria. DLQI response maintenance=response that does not lose more than minimal clinical important difference. DLQI =10-item questionnaire, measured impact of skin disease in participants aged \>=16 years. Children's DLQI (CDLQI): participants aged 4 to15 years. Each question in DLQI and CDLQI evaluated on 4-point scale (range 0=not at all to 3=very much). Scores from10 items were added for DLQI/CDLQI total score, range:0 (not at all) to 30 (very much). Higher scores=more impact on quality of life of participants/children.

Time frame: From randomization to loss of DLQI response or onset of first flare or the last assessment up to first flare (up to maximum of 52 weeks)

Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''number of participants analyzed'' signifies participants evaluable for specified rows.

Arm	Measure	Group	Value (MEDIAN)
Vehicle QD	Duration of Maintenance of Dermatology Life Quality Index (DLQI) Response Until Onset of First Flare During the DB Period	DLQI for participants >=16 years of age	NA Days
Vehicle QD	Duration of Maintenance of Dermatology Life Quality Index (DLQI) Response Until Onset of First Flare During the DB Period	Children's DLQI: participants 4-<16 yrs of age	NA Days
Crisaborole 2% QD	Duration of Maintenance of Dermatology Life Quality Index (DLQI) Response Until Onset of First Flare During the DB Period	DLQI for participants >=16 years of age	NA Days
Crisaborole 2% QD	Duration of Maintenance of Dermatology Life Quality Index (DLQI) Response Until Onset of First Flare During the DB Period	Children's DLQI: participants 4-<16 yrs of age	NA Days

Comparison: DLQI for participants \>=16 years of agep-value: 0.6973Log Rank

Comparison: Children's DLQI: participants 4-\<16 yrs of agep-value: 0.7456Log Rank

Secondary

Duration of Maintenance of Patient Oriented Eczema Measure (POEM) Response Until Onset of First Flare During the DB Period

POEM was a 7-item participant reported outcome measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item was scored as: no days=0, 1-2 days=1, 3-4 days=2, 5-6 days=3 and every day=4. The total score ranged from 0 to 28, where higher score indicated greater severity. POEM response maintenance was defined as the response that does not lose more than minimal clinical important difference. Duration of POEM maintenance was time from randomization to loss of POEM response during 52-week DB period for responders at randomization. Responders were defined as participants with success in ISGA and EASI50 criteria. If an event (e.g., death, first flare \[ISGA \>=2\], lost to follow up, or end of study) occurred before loss of POEM response, duration of maintenance of POEM response was time from randomization to last assessment and was censored. Proxy POEM was used for participants aged 3 months to \<12 years.

Time frame: From randomization to loss POEM response or onset of first flare or the last assessment up to the first flare (up to maximum of 52 weeks)

Arm	Measure	Group	Value (MEDIAN)
Vehicle QD	Duration of Maintenance of Patient Oriented Eczema Measure (POEM) Response Until Onset of First Flare During the DB Period	POEM	55 Days
Vehicle QD	Duration of Maintenance of Patient Oriented Eczema Measure (POEM) Response Until Onset of First Flare During the DB Period	Proxy POEM	20 Days
Crisaborole 2% QD	Duration of Maintenance of Patient Oriented Eczema Measure (POEM) Response Until Onset of First Flare During the DB Period	POEM	180 Days
Crisaborole 2% QD	Duration of Maintenance of Patient Oriented Eczema Measure (POEM) Response Until Onset of First Flare During the DB Period	Proxy POEM	150 Days

Comparison: POEMp-value: 0.0513Log Rank

Comparison: Proxy POEMp-value: 0.0217Log Rank

Secondary

Duration of Pruritus Response Maintenance Until Onset of First Flare During the DB Period: Observer Reported Itch Severity Scale (ORIS) in Participants Aged 3 to <6 Months

Duration of pruritus response maintenance=time from randomization to loss of pruritus response or first flare onset(ISGA\>=2)during52-weekDB period. Evaluated among pruritus responders (success in ISGA, EASI 50) at randomization. Pruritus response maintenance=maintenance of \>=50% improvement in pruritus from baseline obtained at randomization. If event(e.g., death, first flare\[ISGA \>=2\], lost to follow up, or end of study) occurred before loss of pruritus response for first flare-free period, duration of maintenance of pruritus response was time from randomization to last assessment and was censored. Here, pruritus response maintenance duration was presented for participants aged 3 to \<6 months with OL baseline ORIS\>=3 or \>=4 and \>=3 or \>=4 points reduction from OL baseline to randomization in ORIS. Caregivers were asked to rate observation of their child's itch(scratching, rubbing) at worst moment during previous 24 hours on a scale of 0 to 10;0=no itch,10=worst itch imaginable.

Time frame: From randomization up to loss of pruritus response or onset of first flare or the last assessment (maximum of 52 weeks)

Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''number of participants analyzed'' signifies participants evaluable at specified rows.

Arm	Measure	Group	Value (MEDIAN)
Vehicle QD	Duration of Pruritus Response Maintenance Until Onset of First Flare During the DB Period: Observer Reported Itch Severity Scale (ORIS) in Participants Aged 3 to <6 Months	Baseline ORIS Scale >=3 and >=3 point reduction	7 Days
Vehicle QD	Duration of Pruritus Response Maintenance Until Onset of First Flare During the DB Period: Observer Reported Itch Severity Scale (ORIS) in Participants Aged 3 to <6 Months	Baseline ORIS Scale >=4 and >=4 point reduction	8 Days
Crisaborole 2% QD	Duration of Pruritus Response Maintenance Until Onset of First Flare During the DB Period: Observer Reported Itch Severity Scale (ORIS) in Participants Aged 3 to <6 Months	Baseline ORIS Scale >=3 and >=3 point reduction	NA Days
Crisaborole 2% QD	Duration of Pruritus Response Maintenance Until Onset of First Flare During the DB Period: Observer Reported Itch Severity Scale (ORIS) in Participants Aged 3 to <6 Months	Baseline ORIS Scale >=4 and >=4 point reduction	NA Days

Comparison: Baseline ORIS Scale \>=3 and \>=3 point reductionp-value: 0.3778Log Rank

Comparison: Baseline ORIS Scale \>=4 and \>=4 point reductionp-value: 0.487Log Rank

Secondary

EASI Score for the First Flare Period

EASI assessed severity of AD, based on severity of lesion clinical signs (erythema\[E\], induration/papulation\[I\], excoriation\[Ex\], lichenification\[L\]) and % body surface area(BSA) affected.Each of clinical signs scored separately for each of 4 body regions (head and neck\[h\], upper limbs\[u\], trunk\[t\] \[including axillae and groin\], lower limbs\[l\] \[including buttocks\]) on 4-point scale: 0= absent; 1=mild; 2= moderate; 3= severe.EASI area score(A) according to %BSA with AD: 0 (0%), 1(\>0 to \<10%), 2(10 to \<30%), 3(30 to \<50%), 4(50 to \<70%), 5(70 to \<90%), 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh + Ih + Exh + Lh) + 0.2\*Au\*(Eu + Iu + ExU + Lu) + 0.3\*At\*(Et +It + Ext + Lt) + 0.4\*Al\*(El + Il + Exl + Ll). Total EASI score ranged from 0.0 to 72.0, higher score = greater severity of AD.First flare period=time from onset of flare(ISGA\>=2) during DB maintenance period where participant was switched to receive open-label crisaborole ointment 2%,BID for up to 12 weeks until resolution of flares.

Time frame: Week 0 (Day 1), Week 4, Week 8 and Week 12

Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number of Participants Analyzed'' signifies participants evaluable at specified time points.

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	EASI Score for the First Flare Period	Week 0	6.53 Units on a scale	Standard Deviation 5.897
Vehicle QD	EASI Score for the First Flare Period	Week 4	6.09 Units on a scale	Standard Deviation 5.471
Vehicle QD	EASI Score for the First Flare Period	Week 8	4.84 Units on a scale	Standard Deviation 5.322
Vehicle QD	EASI Score for the First Flare Period	Week 12	6.25 Units on a scale	Standard Deviation 4.546
Crisaborole 2% QD	EASI Score for the First Flare Period	Week 12	6.56 Units on a scale	Standard Deviation 5.647
Crisaborole 2% QD	EASI Score for the First Flare Period	Week 0	5.27 Units on a scale	Standard Deviation 3.933
Crisaborole 2% QD	EASI Score for the First Flare Period	Week 8	5.66 Units on a scale	Standard Deviation 4.459
Crisaborole 2% QD	EASI Score for the First Flare Period	Week 4	5.02 Units on a scale	Standard Deviation 3.869

Secondary

European Quality of Life-5 Dimension 5-Level (EQ-5D-5L) Index Score in Participants Greater Than or Equal to (>=) 18 Years of Age: OL Run-in Period

EQ-5D-5L: standardized participant completed questionnaire consisted of 2 components: a health state profile/a single utility index value and an optional VAS. EQ-5D health state profile/a single utility index value had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded no problems for each 5 dimensions, then health state was coded as 11111 with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. US value sets (with all possible health states) was used for adults in the study and total scores ranged from 1 to -0.109. Higher (positive) scores = better health state.

Time frame: Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	European Quality of Life-5 Dimension 5-Level (EQ-5D-5L) Index Score in Participants Greater Than or Equal to (>=) 18 Years of Age: OL Run-in Period	Baseline	0.9 Units on a scale	Standard Deviation 0.12
Vehicle QD	European Quality of Life-5 Dimension 5-Level (EQ-5D-5L) Index Score in Participants Greater Than or Equal to (>=) 18 Years of Age: OL Run-in Period	Week 2	0.9 Units on a scale	Standard Deviation 0.13
Vehicle QD	European Quality of Life-5 Dimension 5-Level (EQ-5D-5L) Index Score in Participants Greater Than or Equal to (>=) 18 Years of Age: OL Run-in Period	Week 4	0.9 Units on a scale	Standard Deviation 0.11
Vehicle QD	European Quality of Life-5 Dimension 5-Level (EQ-5D-5L) Index Score in Participants Greater Than or Equal to (>=) 18 Years of Age: OL Run-in Period	Week 6	0.9 Units on a scale	Standard Deviation 0.12
Vehicle QD	European Quality of Life-5 Dimension 5-Level (EQ-5D-5L) Index Score in Participants Greater Than or Equal to (>=) 18 Years of Age: OL Run-in Period	Week 8	0.9 Units on a scale	Standard Deviation 0.11

Secondary

European Quality of Life-5 Dimension Youth (EuroQoL EQ-5D Y) Index Score in Participants Between 8-17 Years of Age: OL Run-in Period

EQ-5D-Y: child-friendly version of EQ-5D questionnaire related to health status. Health state profile assessed health in 5 dimensions (mobility; looking after myself; doing usual activities; having pain or discomfort; feeling worried, sad or unhappy) used to obtain an index score, each of which had three levels of response (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Participants indicated their health state by choosing the appropriate level from each dimension. The 5 digit health states thus obtained for each dimension were then converted into a single median index value. A health state index score was calculated from individual health profiles using a USA scoring algorithm. Health state index scores generally ranged from -0.109 to 1, where,-0.109= the worst health status, 1= full health. Higher the score the better the health status. A positive change from baseline indicated improvement in health status.

Time frame: Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	European Quality of Life-5 Dimension Youth (EuroQoL EQ-5D Y) Index Score in Participants Between 8-17 Years of Age: OL Run-in Period	Baseline	0.9 Units on a scale	Standard Deviation 0.13
Vehicle QD	European Quality of Life-5 Dimension Youth (EuroQoL EQ-5D Y) Index Score in Participants Between 8-17 Years of Age: OL Run-in Period	Week 2	0.9 Units on a scale	Standard Deviation 0.11
Vehicle QD	European Quality of Life-5 Dimension Youth (EuroQoL EQ-5D Y) Index Score in Participants Between 8-17 Years of Age: OL Run-in Period	Week 4	0.9 Units on a scale	Standard Deviation 0.12
Vehicle QD	European Quality of Life-5 Dimension Youth (EuroQoL EQ-5D Y) Index Score in Participants Between 8-17 Years of Age: OL Run-in Period	Week 6	0.9 Units on a scale	Standard Deviation 0.11
Vehicle QD	European Quality of Life-5 Dimension Youth (EuroQoL EQ-5D Y) Index Score in Participants Between 8-17 Years of Age: OL Run-in Period	Week 8	0.9 Units on a scale	Standard Deviation 0.15

Secondary

EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period

EQ-5D-5L: standardized participant completed questionnaire consisted of 2 components: a health state profile/a single utility index value and an optional VAS. EQ-5D health state profile/a single utility index value had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded no problems for each 5 dimensions, then health state was coded as 11111 with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQoL. US value sets (with all possible health states) was used for adults in the study and total scores ranged from 1 to -0.109. Higher (positive) scores = better health state.

Time frame: Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Baseline	0.9 Units on a scale	Standard Deviation 0.09
Vehicle QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Week 40	0.9 Units on a scale	Standard Deviation 0.1
Vehicle QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Week 20	0.9 Units on a scale	Standard Deviation 0.12
Vehicle QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Week 48	0.9 Units on a scale	Standard Deviation 0.11
Vehicle QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Week 36	0.9 Units on a scale	Standard Deviation 0.09
Vehicle QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Week 24	0.9 Units on a scale	Standard Deviation 0.1
Vehicle QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Week 12	0.9 Units on a scale	Standard Deviation 0.1
Vehicle QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Week 32	0.9 Units on a scale	Standard Deviation 0.11
Vehicle QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Week 28	0.9 Units on a scale	Standard Deviation 0.18
Vehicle QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Week 52	0.9 Units on a scale	Standard Deviation 0.1
Vehicle QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Week 8	0.9 Units on a scale	Standard Deviation 0.09
Vehicle QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Week 44	0.9 Units on a scale	Standard Deviation 0.18
Vehicle QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Week 16	0.9 Units on a scale	Standard Deviation 0.11
Vehicle QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Week 4	0.9 Units on a scale	Standard Deviation 0.12
Crisaborole 2% QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Week 40	0.8 Units on a scale	Standard Deviation 0.24
Crisaborole 2% QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Baseline	0.9 Units on a scale	Standard Deviation 0.11
Crisaborole 2% QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Week 4	0.9 Units on a scale	Standard Deviation 0.1
Crisaborole 2% QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Week 8	0.9 Units on a scale	Standard Deviation 0.1
Crisaborole 2% QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Week 12	0.9 Units on a scale	Standard Deviation 0.18
Crisaborole 2% QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Week 36	0.9 Units on a scale	Standard Deviation 0.13
Crisaborole 2% QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Week 16	0.9 Units on a scale	Standard Deviation 0.15
Crisaborole 2% QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Week 20	0.9 Units on a scale	Standard Deviation 0.15
Crisaborole 2% QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Week 24	0.9 Units on a scale	Standard Deviation 0.21
Crisaborole 2% QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Week 28	0.9 Units on a scale	Standard Deviation 0.14
Crisaborole 2% QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Week 32	0.8 Units on a scale	Standard Deviation 0.22
Crisaborole 2% QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Week 44	0.9 Units on a scale	Standard Deviation 0.14
Crisaborole 2% QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Week 48	0.8 Units on a scale	Standard Deviation 0.23
Crisaborole 2% QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Week 52	0.8 Units on a scale	Standard Deviation 0.24
Crisaborole 2% QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Week 20	0.9 Units on a scale	Standard Deviation 0.09
Crisaborole 2% QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Week 36	1.0 Units on a scale	Standard Deviation 0.09
Crisaborole 2% QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Week 16	0.9 Units on a scale	Standard Deviation 0.08
Crisaborole 2% QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Week 40	1.0 Units on a scale	Standard Deviation 0.06
Crisaborole 2% QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Week 12	0.9 Units on a scale	Standard Deviation 0.09
Crisaborole 2% QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Week 4	0.9 Units on a scale	Standard Deviation 0.14
Crisaborole 2% QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Week 44	1.0 Units on a scale	Standard Deviation 0.07
Crisaborole 2% QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Week 8	0.9 Units on a scale	Standard Deviation 0.17
Crisaborole 2% QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Week 52	0.9 Units on a scale	Standard Deviation 0.07
Crisaborole 2% QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Week 28	1.0 Units on a scale	Standard Deviation 0.06
Crisaborole 2% QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Week 24	0.9 Units on a scale	Standard Deviation 0.07
Crisaborole 2% QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Week 48	1.0 Units on a scale	Standard Deviation 0.06
Crisaborole 2% QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	Week 32	0.9 Units on a scale	Standard Deviation 0.1

Secondary

EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: First Flare Period

Time frame: Weeks 0, 4, 8 and 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: First Flare Period	Week 4	1.0 Units on a scale	Standard Deviation 0.07
Vehicle QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: First Flare Period	Week 0	0.9 Units on a scale	Standard Deviation 0.11
Vehicle QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: First Flare Period	Week 8	1.0 Units on a scale	Standard Deviation 0.06
Vehicle QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: First Flare Period	Week 12	0.9 Units on a scale	Standard Deviation 0.1
Crisaborole 2% QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: First Flare Period	Week 12	0.9 Units on a scale	Standard Deviation 0.1
Crisaborole 2% QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: First Flare Period	Week 8	0.8 Units on a scale	Standard Deviation 0.07
Crisaborole 2% QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: First Flare Period	Week 0	0.9 Units on a scale	Standard Deviation 0.15
Crisaborole 2% QD	EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: First Flare Period	Week 4	0.8 Units on a scale	Standard Deviation 0.19

Secondary

EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period

EQ-5D-5L VAS to record participant's rating for current health-related quality of life state on vertical VAS (0-100);0=worst imaginable health state;100=best imaginable health state.

Time frame: Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Week 40	88.9 Units on a scale	Standard Deviation 12.99
Vehicle QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Week 20	87.1 Units on a scale	Standard Deviation 13.77
Vehicle QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Week 8	90.7 Units on a scale	Standard Deviation 7.76
Vehicle QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Week 36	90.8 Units on a scale	Standard Deviation 8.68
Vehicle QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Week 24	89.2 Units on a scale	Standard Deviation 10.98
Vehicle QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Week 4	89.9 Units on a scale	Standard Deviation 9
Vehicle QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Week 32	90.0 Units on a scale	Standard Deviation 8.91
Vehicle QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Week 28	88.3 Units on a scale	Standard Deviation 9.29
Vehicle QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Week 48	88.8 Units on a scale	Standard Deviation 12.9
Vehicle QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Week 12	88.5 Units on a scale	Standard Deviation 13.72
Vehicle QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Baseline	88.3 Units on a scale	Standard Deviation 9.41
Vehicle QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Week 44	87.2 Units on a scale	Standard Deviation 13.64
Vehicle QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Week 16	88.1 Units on a scale	Standard Deviation 11.86
Vehicle QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Week 52	90.0 Units on a scale	Standard Deviation 11.44
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Week 52	82.7 Units on a scale	Standard Deviation 20.98
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Baseline	85.2 Units on a scale	Standard Deviation 15.56
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Week 4	86.8 Units on a scale	Standard Deviation 10.74
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Week 8	87.3 Units on a scale	Standard Deviation 12.02
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Week 12	80.5 Units on a scale	Standard Deviation 21.68
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Week 16	82.7 Units on a scale	Standard Deviation 18.94
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Week 20	82.7 Units on a scale	Standard Deviation 14.47
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Week 24	83.1 Units on a scale	Standard Deviation 19.39
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Week 28	83.7 Units on a scale	Standard Deviation 16.57
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Week 32	83.0 Units on a scale	Standard Deviation 20.02
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Week 36	83.4 Units on a scale	Standard Deviation 12.8
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Week 40	82.4 Units on a scale	Standard Deviation 20.68
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Week 44	81.9 Units on a scale	Standard Deviation 13.96
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Week 48	85.1 Units on a scale	Standard Deviation 20.92
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Week 52	83.7 Units on a scale	Standard Deviation 10.55
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Week 36	86.8 Units on a scale	Standard Deviation 8.3
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Week 16	88.7 Units on a scale	Standard Deviation 9
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Week 48	86.9 Units on a scale	Standard Deviation 11.13
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Week 40	93.8 Units on a scale	Standard Deviation 5.76
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Week 12	88.1 Units on a scale	Standard Deviation 8.69
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Week 4	81.9 Units on a scale	Standard Deviation 16.81
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Week 44	87.0 Units on a scale	Standard Deviation 10.26
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Week 28	81.2 Units on a scale	Standard Deviation 7.26
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Week 24	88.0 Units on a scale	Standard Deviation 8.93
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Week 8	83.8 Units on a scale	Standard Deviation 17.75
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Week 32	83.2 Units on a scale	Standard Deviation 13.37
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	Week 20	85.3 Units on a scale	Standard Deviation 6.56

Secondary

EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period

EQ-5D-5L VAS was used to record participant's rating for current health-related quality of life state on vertical VAS (0-100);0=worst imaginable health state;100=best imaginable health state.

Time frame: Baseline (the last observation up to and including randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period	Baseline	88.3 Units on a scale	Standard Deviation 9.41
Vehicle QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 4	89.6 Units on a scale	Standard Deviation 9.11
Vehicle QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 8	91.3 Units on a scale	Standard Deviation 7.44
Vehicle QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 12	91.9 Units on a scale	Standard Deviation 8.86
Vehicle QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 16	91.3 Units on a scale	Standard Deviation 9.74
Vehicle QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 20	88.1 Units on a scale	Standard Deviation 12.01
Vehicle QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 24	92.6 Units on a scale	Standard Deviation 8.26
Vehicle QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 28	91.9 Units on a scale	Standard Deviation 7.06
Vehicle QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 32	91.5 Units on a scale	Standard Deviation 6.7
Vehicle QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 36	91.3 Units on a scale	Standard Deviation 9.83
Vehicle QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 40	93.1 Units on a scale	Standard Deviation 7.95
Vehicle QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 44	91.1 Units on a scale	Standard Deviation 9.63
Vehicle QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 48	92.5 Units on a scale	Standard Deviation 9.28
Vehicle QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 52	93.7 Units on a scale	Standard Deviation 7.75
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 40	87.2 Units on a scale	Standard Deviation 13.76
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period	Baseline	85.2 Units on a scale	Standard Deviation 15.56
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 28	96.3 Units on a scale	Standard Deviation 2.75
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 4	86.8 Units on a scale	Standard Deviation 10.74
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 48	92.4 Units on a scale	Standard Deviation 8.17
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 8	88.5 Units on a scale	Standard Deviation 11.29
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 32	89.5 Units on a scale	Standard Deviation 8.88
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 12	83.8 Units on a scale	Standard Deviation 15.36
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 44	88.0 Units on a scale	Standard Deviation 11.78
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 16	86.1 Units on a scale	Standard Deviation 11.88
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 36	92.7 Units on a scale	Standard Deviation 10.12
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 20	87.5 Units on a scale	Standard Deviation 14.01
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 52	88.9 Units on a scale	Standard Deviation 9.7
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 24	88.1 Units on a scale	Standard Deviation 9.77

Secondary

EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Period

EQ-5D-5L VAS was used to record participant's rating for his/her current health-related quality of life state on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state.

Time frame: Weeks 0, 4, 8 and 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Period	Week 0	84.1 Units on a scale	Standard Deviation 10.4
Vehicle QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Period	Week 4	87.9 Units on a scale	Standard Deviation 8.02
Vehicle QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Period	Week 8	88.6 Units on a scale	Standard Deviation 6.71
Vehicle QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Period	Week 12	83.7 Units on a scale	Standard Deviation 11.85
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Period	Week 12	85.0 Units on a scale	Standard Deviation 21.79
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Period	Week 0	82.8 Units on a scale	Standard Deviation 17.81
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Period	Week 8	88.2 Units on a scale	Standard Deviation 9.25
Crisaborole 2% QD	EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Period	Week 4	81.1 Units on a scale	Standard Deviation 22.15

Secondary

EuroQoL EQ-5D-5L Visual Analog Scale (VAS) Score in Participants >= 18 Years of Age: OL Run-in Period

EQ-5D-5L VAS was used to record participant's rating for current health-related quality of life state on vertical VAS (0-100);0=worst imaginable health state;100=best imaginable health state.

Time frame: Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	EuroQoL EQ-5D-5L Visual Analog Scale (VAS) Score in Participants >= 18 Years of Age: OL Run-in Period	Week 8	84.2 Units on a scale	Standard Deviation 14.18
Vehicle QD	EuroQoL EQ-5D-5L Visual Analog Scale (VAS) Score in Participants >= 18 Years of Age: OL Run-in Period	Baseline	81.2 Units on a scale	Standard Deviation 15.81
Vehicle QD	EuroQoL EQ-5D-5L Visual Analog Scale (VAS) Score in Participants >= 18 Years of Age: OL Run-in Period	Week 2	82.2 Units on a scale	Standard Deviation 16.14
Vehicle QD	EuroQoL EQ-5D-5L Visual Analog Scale (VAS) Score in Participants >= 18 Years of Age: OL Run-in Period	Week 4	82.0 Units on a scale	Standard Deviation 15.73
Vehicle QD	EuroQoL EQ-5D-5L Visual Analog Scale (VAS) Score in Participants >= 18 Years of Age: OL Run-in Period	Week 6	84.0 Units on a scale	Standard Deviation 14.89

Secondary

EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period

Time frame: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period	Baseline	0.9 Units on a scale	Standard Deviation 0.09
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 4	0.9 Units on a scale	Standard Deviation 0.12
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 8	0.9 Units on a scale	Standard Deviation 0.1
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 12	1.0 Units on a scale	Standard Deviation 0.09
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 16	0.9 Units on a scale	Standard Deviation 0.11
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 20	0.9 Units on a scale	Standard Deviation 0.09
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 24	0.9 Units on a scale	Standard Deviation 0.1
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 28	1.0 Units on a scale	Standard Deviation 0.07
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 32	0.9 Units on a scale	Standard Deviation 0.1
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 36	0.9 Units on a scale	Standard Deviation 0.08
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 40	1.0 Units on a scale	Standard Deviation 0.08
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 44	1.0 Units on a scale	Standard Deviation 0.07
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 48	0.9 Units on a scale	Standard Deviation 0.11
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 52	0.9 Units on a scale	Standard Deviation 0.1
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 40	0.9 Units on a scale	Standard Deviation 0.18
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period	Baseline	0.9 Units on a scale	Standard Deviation 0.11
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 28	1.0 Units on a scale	Standard Deviation 0
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 4	0.9 Units on a scale	Standard Deviation 0.1
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 48	0.9 Units on a scale	Standard Deviation 0.11
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 8	0.9 Units on a scale	Standard Deviation 0.09
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 32	0.9 Units on a scale	Standard Deviation 0.12
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 12	0.9 Units on a scale	Standard Deviation 0.09
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 44	1.0 Units on a scale	Standard Deviation 0.07
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 16	0.9 Units on a scale	Standard Deviation 0.1
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 36	1.0 Units on a scale	Standard Deviation 0
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 20	0.9 Units on a scale	Standard Deviation 0.15
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 52	0.9 Units on a scale	Standard Deviation 0.12
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period	Week 24	0.9 Units on a scale	Standard Deviation 0.1

Secondary

EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period

Time frame: Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Week 20	0.9 Units on a scale	Standard Deviation 0.09
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Week 4	1.0 Units on a scale	Standard Deviation 0.07
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Week 40	1.0 Units on a scale	Standard Deviation 0.07
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Week 24	1.0 Units on a scale	Standard Deviation 0.07
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Week 48	1.0 Units on a scale	Standard Deviation 0.07
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Week 36	1.0 Units on a scale	Standard Deviation 0.08
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Week 28	0.9 Units on a scale	Standard Deviation 0.09
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Week 12	1.0 Units on a scale	Standard Deviation 0.06
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Week 32	1.0 Units on a scale	Standard Deviation 0.06
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Week 52	1.0 Units on a scale	Standard Deviation 0.07
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Week 44	1.0 Units on a scale	Standard Deviation 0.08
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Week 16	1.0 Units on a scale	Standard Deviation 0.08
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Week 8	1.0 Units on a scale	Standard Deviation 0.07
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Baseline	0.9 Units on a scale	Standard Deviation 0.08
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Week 40	0.9 Units on a scale	Standard Deviation 0.13
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Baseline	0.9 Units on a scale	Standard Deviation 0.18
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Week 4	1.0 Units on a scale	Standard Deviation 0.07
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Week 8	1.0 Units on a scale	Standard Deviation 0.08
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Week 12	1.0 Units on a scale	Standard Deviation 0.07
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Week 16	1.0 Units on a scale	Standard Deviation 0.07
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Week 20	1.0 Units on a scale	Standard Deviation 0.05
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Week 24	1.0 Units on a scale	Standard Deviation 0.06
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Week 28	0.9 Units on a scale	Standard Deviation 0.08
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Week 32	1.0 Units on a scale	Standard Deviation 0.06
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Week 36	1.0 Units on a scale	Standard Deviation 0.08
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Week 44	0.9 Units on a scale	Standard Deviation 0.22
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Week 48	0.9 Units on a scale	Standard Deviation 0.09
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Week 52	1.0 Units on a scale	Standard Deviation 0.07
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Week 36	0.9 Units on a scale	Standard Deviation 0.09
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Week 20	0.9 Units on a scale	Standard Deviation 0.09
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Week 16	0.9 Units on a scale	Standard Deviation 0.09
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Week 40	1.0 Units on a scale	Standard Deviation 0.08
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Week 12	0.9 Units on a scale	Standard Deviation 0.1
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Week 4	0.9 Units on a scale	Standard Deviation 0.21
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Week 44	0.9 Units on a scale	Standard Deviation 0.09
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Week 8	0.9 Units on a scale	Standard Deviation 0.1
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Week 28	0.9 Units on a scale	Standard Deviation 0.14
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Week 52	1.0 Units on a scale	Standard Deviation 0.08
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Week 32	0.9 Units on a scale	Standard Deviation 0.11
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Week 24	0.9 Units on a scale	Standard Deviation 0.12
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	Week 48	0.9 Units on a scale	Standard Deviation 0.09

Secondary

EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period

Time frame: Baseline (the last observation up to and including randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 28	1.0 Units on a scale	—
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 16	1.0 Units on a scale	Standard Deviation 0.07
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 32	1.0 Units on a scale	Standard Deviation 0.07
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 4	1.0 Units on a scale	Standard Deviation 0.06
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 20	0.8 Units on a scale	Standard Deviation 0.01
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 40	0.9 Units on a scale	Standard Deviation 0.09
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 12	1.0 Units on a scale	Standard Deviation 0.07
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 24	1.0 Units on a scale	Standard Deviation 0.07
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 48	1.0 Units on a scale	Standard Deviation 0.08
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 8	1.0 Units on a scale	Standard Deviation 0.05
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 52	1.0 Units on a scale	Standard Deviation 0.09
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Baseline	0.9 Units on a scale	Standard Deviation 0.08
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 44	0.9 Units on a scale	Standard Deviation 0.25
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 48	0.9 Units on a scale	Standard Deviation 0.09
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 52	1.0 Units on a scale	Standard Deviation 0.07
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Baseline	0.9 Units on a scale	Standard Deviation 0.18
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 4	1.0 Units on a scale	Standard Deviation 0.07
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 8	1.0 Units on a scale	Standard Deviation 0.08
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 12	1.0 Units on a scale	Standard Deviation 0.06
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 16	1.0 Units on a scale	Standard Deviation 0.07
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 20	1.0 Units on a scale	Standard Deviation 0.05
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 24	1.0 Units on a scale	Standard Deviation 0.06
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 28	1.0 Units on a scale	Standard Deviation 0.07
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 32	1.0 Units on a scale	Standard Deviation 0.07
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 36	1.0 Units on a scale	Standard Deviation 0.08
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 40	0.9 Units on a scale	Standard Deviation 0.14

Secondary

EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Period

Time frame: Weeks 0, 4, 8 and 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Period	Week 0	0.9 Units on a scale	Standard Deviation 0.09
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Period	Week 4	0.9 Units on a scale	Standard Deviation 0.09
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Period	Week 8	0.9 Units on a scale	Standard Deviation 0.1
Vehicle QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Period	Week 12	1.0 Units on a scale	—
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Period	Week 12	0.9 Units on a scale	Standard Deviation 0.09
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Period	Week 0	0.8 Units on a scale	Standard Deviation 0.25
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Period	Week 8	0.9 Units on a scale	Standard Deviation 0.11
Crisaborole 2% QD	EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Period	Week 4	0.9 Units on a scale	Standard Deviation 0.13

Secondary

EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period

EQ-5D-Y:child-friendly version of EQ-5D questionnaire related to health status.Health state profile assessed health in 5 dimensions(Mobility;Looking After Myself;Doing Usual Activities;Having Pain or Discomfort;Feeling Worried,Sad or Unhappy)used to obtain index score,each of which had three levels of response(no problems/no pain/not worried,some problems/some pain/a bit worried,a lot of problems/a lot of pain/very worried).Participants indicated health state by choosing appropriate level from each dimension.5-digit health states obtained for each dimension were converted into single median index value using index value calculator,recommended by EuroQoL group.Health state index score calculated from individual health profiles using USA scoring algorithm. Scores ranged from -0.109 to 1,where, -0.109=worst health status, 1=full health. Higher score=better health status.Positive change from baseline indicated improvement in health status.Proxy version filled by care-giver of participant.

Time frame: Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Week 40	0.9 Units on a scale	Standard Deviation 0.09
Vehicle QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Week 20	0.9 Units on a scale	Standard Deviation 0.1
Vehicle QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Week 52	1.0 Units on a scale	Standard Deviation 0.05
Vehicle QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Week 36	1.0 Units on a scale	Standard Deviation 0.05
Vehicle QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Week 8	0.9 Units on a scale	Standard Deviation 0.09
Vehicle QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Week 32	1.0 Units on a scale	Standard Deviation 0.06
Vehicle QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Week 28	0.9 Units on a scale	Standard Deviation 0.09
Vehicle QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Week 24	1.0 Units on a scale	Standard Deviation 0.08
Vehicle QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Week 48	1.0 Units on a scale	Standard Deviation 0.07
Vehicle QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Week 12	1.0 Units on a scale	Standard Deviation 0.07
Vehicle QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Week 4	0.9 Units on a scale	Standard Deviation 0.09
Vehicle QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Week 44	1.0 Units on a scale	Standard Deviation 0.07
Vehicle QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Week 16	1.0 Units on a scale	Standard Deviation 0.09
Vehicle QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Baseline	1.0 Units on a scale	Standard Deviation 0.08
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Week 40	0.9 Units on a scale	Standard Deviation 0.08
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Baseline	0.9 Units on a scale	Standard Deviation 0.12
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Week 4	0.9 Units on a scale	Standard Deviation 0.14
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Week 12	0.9 Units on a scale	Standard Deviation 0.13
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Week 16	1.0 Units on a scale	Standard Deviation 0.07
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Week 20	0.9 Units on a scale	Standard Deviation 0.15
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Week 24	1.0 Units on a scale	Standard Deviation 0.07
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Week 28	0.9 Units on a scale	Standard Deviation 0.09
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Week 32	1.0 Units on a scale	Standard Deviation 0.07
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Week 36	0.9 Units on a scale	Standard Deviation 0.1
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Week 8	0.9 Units on a scale	Standard Deviation 0.09
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Week 44	0.9 Units on a scale	Standard Deviation 0.1
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Week 48	1.0 Units on a scale	Standard Deviation 0.07
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Week 52	1.0 Units on a scale	Standard Deviation 0
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Week 36	0.9 Units on a scale	Standard Deviation 0.11
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Week 16	0.9 Units on a scale	Standard Deviation 0.11
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Week 48	0.9 Units on a scale	Standard Deviation 0.11
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Week 40	0.9 Units on a scale	Standard Deviation 0.12
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Week 12	0.8 Units on a scale	Standard Deviation 0.18
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Week 4	0.8 Units on a scale	Standard Deviation 0.19
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Week 44	0.9 Units on a scale	Standard Deviation 0.14
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Week 28	0.9 Units on a scale	Standard Deviation 0.09
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Week 24	0.9 Units on a scale	Standard Deviation 0.2
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Week 8	0.8 Units on a scale	Standard Deviation 0.15
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Week 32	0.9 Units on a scale	Standard Deviation 0.11
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Week 20	0.8 Units on a scale	Standard Deviation 0.12
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	Week 52	0.9 Units on a scale	Standard Deviation 0.11

Secondary

EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period

Time frame: Baseline (the last observation up to and including randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 32	0.9 Units on a scale	Standard Deviation 0.11
Vehicle QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 48	0.9 Units on a scale	Standard Deviation 0.11
Vehicle QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 20	0.9 Units on a scale	Standard Deviation 0.12
Vehicle QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 52	1.0 Units on a scale	Standard Deviation 0.06
Vehicle QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 36	1.0 Units on a scale	—
Vehicle QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Baseline	1.0 Units on a scale	Standard Deviation 0.08
Vehicle QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 28	0.9 Units on a scale	Standard Deviation 0.12
Vehicle QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 4	0.9 Units on a scale	Standard Deviation 0.1
Vehicle QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 40	0.9 Units on a scale	Standard Deviation 0.11
Vehicle QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 8	1.0 Units on a scale	Standard Deviation 0.08
Vehicle QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 24	0.9 Units on a scale	Standard Deviation 0.08
Vehicle QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 12	1.0 Units on a scale	Standard Deviation 0.09
Vehicle QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 44	1.0 Units on a scale	—
Vehicle QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 16	0.9 Units on a scale	Standard Deviation 0.09
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 44	1.0 Units on a scale	—
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 20	1.0 Units on a scale	Standard Deviation 0
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 24	1.0 Units on a scale	Standard Deviation 0
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 28	0.9 Units on a scale	Standard Deviation 0.09
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 32	1.0 Units on a scale	Standard Deviation 0
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 36	1.0 Units on a scale	Standard Deviation 0
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 40	1.0 Units on a scale	Standard Deviation 0
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 16	1.0 Units on a scale	Standard Deviation 0
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 48	1.0 Units on a scale	Standard Deviation 0
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 52	1.0 Units on a scale	Standard Deviation 0
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Baseline	0.9 Units on a scale	Standard Deviation 0.12
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 4	0.9 Units on a scale	Standard Deviation 0.14
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 8	1.0 Units on a scale	Standard Deviation 0.08
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 12	1.0 Units on a scale	Standard Deviation 0.06

Secondary

EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Period

Time frame: Weeks 0, 4, 8 and 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Period	Week 0	0.8 Units on a scale	Standard Deviation 0.22
Vehicle QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Period	Week 4	0.9 Units on a scale	Standard Deviation 0.18
Vehicle QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Period	Week 8	0.9 Units on a scale	Standard Deviation 0.11
Vehicle QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Period	Week 12	0.9 Units on a scale	Standard Deviation 0.1
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Period	Week 12	1.0 Units on a scale	—
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Period	Week 0	0.8 Units on a scale	Standard Deviation 0.15
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Period	Week 8	0.8 Units on a scale	Standard Deviation 0.2
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Period	Week 4	0.9 Units on a scale	Standard Deviation 0.16

Secondary

EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: OL Run-in Period

Time frame: Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: OL Run-in Period	Baseline	0.8 Units on a scale	Standard Deviation 0.17
Vehicle QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: OL Run-in Period	Week 2	0.9 Units on a scale	Standard Deviation 0.16
Vehicle QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: OL Run-in Period	Week 4	0.9 Units on a scale	Standard Deviation 0.17
Vehicle QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: OL Run-in Period	Week 6	0.9 Units on a scale	Standard Deviation 0.17
Vehicle QD	EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: OL Run-in Period	Week 8	0.9 Units on a scale	Standard Deviation 0.18

Secondary

EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period

EQ-5D Y proxy VAS assessed the caregiver's impression of participants health state on a vertical VAS (range: 0 to 100), where, 0 (the worst imaginable health) to 100 (the best imaginable health).

Time frame: Baseline (the last observation up to and including Day 1 of DB period),Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Week 20	94.9 Units on a scale	Standard Deviation 5.09
Vehicle QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Week 4	94.6 Units on a scale	Standard Deviation 5.86
Vehicle QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Week 40	93.7 Units on a scale	Standard Deviation 7.76
Vehicle QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Week 24	95.1 Units on a scale	Standard Deviation 5.62
Vehicle QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Week 48	96.1 Units on a scale	Standard Deviation 5.15
Vehicle QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Week 36	97.4 Units on a scale	Standard Deviation 2.99
Vehicle QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Week 28	95.8 Units on a scale	Standard Deviation 5.6
Vehicle QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Week 12	95.2 Units on a scale	Standard Deviation 5.47
Vehicle QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Week 32	95.5 Units on a scale	Standard Deviation 5.7
Vehicle QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Week 52	95.0 Units on a scale	Standard Deviation 5.51
Vehicle QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Week 44	96.6 Units on a scale	Standard Deviation 4.6
Vehicle QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Week 16	92.9 Units on a scale	Standard Deviation 7.08
Vehicle QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Week 8	93.0 Units on a scale	Standard Deviation 7.39
Vehicle QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Baseline	93.8 Units on a scale	Standard Deviation 9.97
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Week 40	96.8 Units on a scale	Standard Deviation 3.46
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Baseline	94.3 Units on a scale	Standard Deviation 8.16
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Week 4	96.3 Units on a scale	Standard Deviation 6.54
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Week 8	96.3 Units on a scale	Standard Deviation 6.17
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Week 12	96.8 Units on a scale	Standard Deviation 3.73
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Week 16	96.5 Units on a scale	Standard Deviation 2.81
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Week 20	93.4 Units on a scale	Standard Deviation 6.5
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Week 24	95.7 Units on a scale	Standard Deviation 4.62
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Week 28	97.1 Units on a scale	Standard Deviation 4.17
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Week 32	96.9 Units on a scale	Standard Deviation 2.12
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Week 36	97.8 Units on a scale	Standard Deviation 2.49
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Week 44	97.8 Units on a scale	Standard Deviation 2.71
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Week 48	96.9 Units on a scale	Standard Deviation 4.01
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Week 52	96.7 Units on a scale	Standard Deviation 3.97
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Week 36	93.5 Units on a scale	Standard Deviation 5.71
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Week 20	92.7 Units on a scale	Standard Deviation 5.07
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Week 16	93.2 Units on a scale	Standard Deviation 6.29
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Week 40	92.9 Units on a scale	Standard Deviation 5.28
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Week 12	91.5 Units on a scale	Standard Deviation 10.81
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Week 4	89.4 Units on a scale	Standard Deviation 11.28
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Week 44	93.0 Units on a scale	Standard Deviation 5.14
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Week 8	91.8 Units on a scale	Standard Deviation 7.49
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Week 28	93.2 Units on a scale	Standard Deviation 5.65
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Week 52	96.6 Units on a scale	Standard Deviation 3.11
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Week 32	93.1 Units on a scale	Standard Deviation 6.98
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Week 24	91.9 Units on a scale	Standard Deviation 7.77
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	Week 48	93.4 Units on a scale	Standard Deviation 5.57

Secondary

EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period

EQ-5D Y proxy VAS assessed the caregiver's impression of participants health state on a vertical VAS (range: 0 to 100), where, 0 (the worst imaginable health) to 100 (the best imaginable health).

Time frame: Baseline (the last observation up to and including randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Baseline	93.8 Units on a scale	Standard Deviation 9.97
Vehicle QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 4	94.6 Units on a scale	Standard Deviation 6.05
Vehicle QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 8	94.3 Units on a scale	Standard Deviation 7.06
Vehicle QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 12	94.4 Units on a scale	Standard Deviation 5.95
Vehicle QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 16	93.7 Units on a scale	Standard Deviation 8.22
Vehicle QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 20	96.5 Units on a scale	Standard Deviation 4.95
Vehicle QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 24	90.0 Units on a scale	Standard Deviation 8.49
Vehicle QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 28	100.0 Units on a scale	Standard Deviation 0
Vehicle QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 32	92.0 Units on a scale	Standard Deviation 8.45
Vehicle QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 36	100.0 Units on a scale	—
Vehicle QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 40	91.5 Units on a scale	Standard Deviation 9.33
Vehicle QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 44	100.0 Units on a scale	—
Vehicle QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 48	94.0 Units on a scale	Standard Deviation 5.35
Vehicle QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 52	96.4 Units on a scale	Standard Deviation 4.16
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 40	99.3 Units on a scale	Standard Deviation 0.58
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Baseline	94.3 Units on a scale	Standard Deviation 8.16
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 28	100.0 Units on a scale	Standard Deviation 0
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 4	96.3 Units on a scale	Standard Deviation 6.54
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 48	99.0 Units on a scale	Standard Deviation 1.73
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 8	96.0 Units on a scale	Standard Deviation 7.29
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 32	97.8 Units on a scale	Standard Deviation 1.71
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 12	98.3 Units on a scale	Standard Deviation 2.26
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 44	100.0 Units on a scale	—
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 16	98.2 Units on a scale	Standard Deviation 2.23
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 36	98.3 Units on a scale	Standard Deviation 2.89
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 20	93.7 Units on a scale	Standard Deviation 10.97
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 52	98.7 Units on a scale	Standard Deviation 2.31
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period	Week 24	95.7 Units on a scale	Standard Deviation 5.01

Secondary

EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Period

EQ-5D Y proxy VAS assessed the caregiver's impression of participants health state on a vertical VAS (range: 0 to 100), where, 0 (the worst imaginable health) to 100 (the best imaginable health).

Time frame: Weeks 0, 4, 8 and 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Period	Week 0	84.7 Units on a scale	Standard Deviation 21.55
Vehicle QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Period	Week 8	93.8 Units on a scale	Standard Deviation 5.29
Vehicle QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Period	Week 4	90.3 Units on a scale	Standard Deviation 13.53
Vehicle QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Period	Week 12	90.0 Units on a scale	Standard Deviation 10.61
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Period	Week 4	91.3 Units on a scale	Standard Deviation 7.69
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Period	Week 0	91.0 Units on a scale	Standard Deviation 7.84
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Period	Week 12	99.0 Units on a scale	—
Crisaborole 2% QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Period	Week 8	93.0 Units on a scale	Standard Deviation 7.9

Secondary

EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: OL Run-in Period

EQ-5D Y proxy VAS assessed the caregiver's impression of participants health state on a vertical VAS (range: 0 to 100), where, 0 (the worst imaginable health) to 100 (the best imaginable health).

Time frame: Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: OL Run-in Period	Baseline	86.0 Units on a scale	Standard Deviation 13.97
Vehicle QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: OL Run-in Period	Week 2	87.6 Units on a scale	Standard Deviation 12.61
Vehicle QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: OL Run-in Period	Week 4	90.0 Units on a scale	Standard Deviation 11.05
Vehicle QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: OL Run-in Period	Week 6	90.4 Units on a scale	Standard Deviation 11.45
Vehicle QD	EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: OL Run-in Period	Week 8	90.8 Units on a scale	Standard Deviation 11.63

Secondary

EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period

EQ-5D Y VAS was a child-friendly version of EQ-5D questionnaire related to health status used to record participant's rating for his/her current health-related quality of life state on vertical VAS (0-100);0 = worst imaginable health state and 100 = best imaginable health state.

Time frame: Baseline (the last observation up to and including Day 1 of OL period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Week 20	85.1 Units on a scale	Standard Deviation 10.89
Vehicle QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Week 4	88.3 Units on a scale	Standard Deviation 11.29
Vehicle QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Week 40	92.2 Units on a scale	Standard Deviation 9.03
Vehicle QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Week 24	91.7 Units on a scale	Standard Deviation 10.92
Vehicle QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Week 48	92.1 Units on a scale	Standard Deviation 9.75
Vehicle QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Week 36	90.7 Units on a scale	Standard Deviation 10.34
Vehicle QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Week 28	89.9 Units on a scale	Standard Deviation 12.09
Vehicle QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Week 12	91.9 Units on a scale	Standard Deviation 9.18
Vehicle QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Week 32	91.1 Units on a scale	Standard Deviation 9.4
Vehicle QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Week 52	90.9 Units on a scale	Standard Deviation 13.75
Vehicle QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Week 44	93.5 Units on a scale	Standard Deviation 8.7
Vehicle QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Week 16	91.3 Units on a scale	Standard Deviation 8.2
Vehicle QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Week 8	89.6 Units on a scale	Standard Deviation 9.52
Vehicle QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Baseline	86.8 Units on a scale	Standard Deviation 14.86
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Week 40	89.8 Units on a scale	Standard Deviation 13.25
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Baseline	91.1 Units on a scale	Standard Deviation 9.34
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Week 4	91.6 Units on a scale	Standard Deviation 7.27
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Week 8	88.6 Units on a scale	Standard Deviation 14.34
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Week 12	89.1 Units on a scale	Standard Deviation 13.36
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Week 16	88.9 Units on a scale	Standard Deviation 13.91
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Week 20	87.8 Units on a scale	Standard Deviation 21.65
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Week 24	89.3 Units on a scale	Standard Deviation 12.83
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Week 28	90.4 Units on a scale	Standard Deviation 13.36
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Week 32	91.5 Units on a scale	Standard Deviation 12.98
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Week 36	91.7 Units on a scale	Standard Deviation 14.86
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Week 44	88.3 Units on a scale	Standard Deviation 15.81
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Week 48	91.3 Units on a scale	Standard Deviation 13.64
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Week 52	92.6 Units on a scale	Standard Deviation 11.27
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Week 36	88.5 Units on a scale	Standard Deviation 10.88
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Week 20	90.1 Units on a scale	Standard Deviation 9.43
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Week 16	87.6 Units on a scale	Standard Deviation 9.87
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Week 40	90.6 Units on a scale	Standard Deviation 10.02
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Week 12	87.9 Units on a scale	Standard Deviation 13.5
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Week 4	84.7 Units on a scale	Standard Deviation 14.13
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Week 44	88.0 Units on a scale	Standard Deviation 11.16
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Week 8	89.6 Units on a scale	Standard Deviation 8.36
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Week 28	84.8 Units on a scale	Standard Deviation 12.56
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Week 52	93.6 Units on a scale	Standard Deviation 7.91
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Week 32	88.7 Units on a scale	Standard Deviation 9.89
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Week 24	88.0 Units on a scale	Standard Deviation 11.94
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	Week 48	96.1 Units on a scale	Standard Deviation 5.18

Secondary

EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period

Time frame: Baseline (the last observation up to and including randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 28	96.0 Units on a scale	—
Vehicle QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 16	92.9 Units on a scale	Standard Deviation 8.01
Vehicle QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 32	92.1 Units on a scale	Standard Deviation 8.43
Vehicle QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 4	87.7 Units on a scale	Standard Deviation 11.74
Vehicle QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 20	84.0 Units on a scale	Standard Deviation 12.73
Vehicle QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 40	95.2 Units on a scale	Standard Deviation 4.75
Vehicle QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 12	89.8 Units on a scale	Standard Deviation 11.01
Vehicle QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 24	92.7 Units on a scale	Standard Deviation 12.04
Vehicle QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 48	93.8 Units on a scale	Standard Deviation 7.5
Vehicle QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 8	88.8 Units on a scale	Standard Deviation 10.96
Vehicle QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 52	98.5 Units on a scale	Standard Deviation 1.91
Vehicle QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Baseline	86.8 Units on a scale	Standard Deviation 14.86
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 44	88.0 Units on a scale	Standard Deviation 16.46
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 48	89.1 Units on a scale	Standard Deviation 15.72
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 52	90.7 Units on a scale	Standard Deviation 13.53
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Baseline	91.1 Units on a scale	Standard Deviation 9.34
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 4	91.6 Units on a scale	Standard Deviation 7.27
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 8	87.6 Units on a scale	Standard Deviation 14.84
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 12	87.9 Units on a scale	Standard Deviation 13.7
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 16	87.9 Units on a scale	Standard Deviation 14.74
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 20	86.1 Units on a scale	Standard Deviation 23.22
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 24	89.8 Units on a scale	Standard Deviation 13.76
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 28	86.6 Units on a scale	Standard Deviation 15.4
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 32	88.8 Units on a scale	Standard Deviation 14.68
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 36	89.0 Units on a scale	Standard Deviation 18.25
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period	Week 40	89.6 Units on a scale	Standard Deviation 14.01

Secondary

EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Period

Time frame: Weeks 0, 4, 8 and 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Period	Baseline	86.5 Units on a scale	Standard Deviation 10.87
Vehicle QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Period	Week 4	91.5 Units on a scale	Standard Deviation 8.91
Vehicle QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Period	Week 8	85.3 Units on a scale	Standard Deviation 17.58
Vehicle QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Period	Week 12	100.0 Units on a scale	—
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Period	Week 12	81.0 Units on a scale	Standard Deviation 4.18
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Period	Baseline	88.7 Units on a scale	Standard Deviation 10.27
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Period	Week 8	87.0 Units on a scale	Standard Deviation 9.49
Crisaborole 2% QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Period	Week 4	82.3 Units on a scale	Standard Deviation 18.55

Secondary

EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age : OL-Run-in Period

EQ-5D Y VAS was used to record participant's rating for his/her current health-related quality of life state on vertical VAS (0-100);0 = worst imaginable health state and 100 = best imaginable health state.

Time frame: Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age : OL-Run-in Period	Baseline	85.6 Units on a scale	Standard Deviation 16.27
Vehicle QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age : OL-Run-in Period	Week 2	87.4 Units on a scale	Standard Deviation 11.91
Vehicle QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age : OL-Run-in Period	Week 4	87.5 Units on a scale	Standard Deviation 12.92
Vehicle QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age : OL-Run-in Period	Week 6	87.9 Units on a scale	Standard Deviation 12.72
Vehicle QD	EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age : OL-Run-in Period	Week 8	88.0 Units on a scale	Standard Deviation 12.93

Secondary

Investigator's Static Global Assessment (ISGA) Score for the First Flare Period

ISGA:5- point global assessment scale of AD severity, used to characterize overall disease severity across all treatable AD lesions (excluding the scalp). Score ranged from 0 to 4: where 0= clear(minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicate greater severity of AD. First flare period was the time from the onset of flare (ISGA\>=2) during DB maintenance period where the participant was switched to receive open-label crisaborole ointment 2%, BID for up to 12 weeks until resolution of flares.

Time frame: Week 0 (Day 1), Week 4, Week 8 and Week 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Investigator's Static Global Assessment (ISGA) Score for the First Flare Period	Week 0	2.4 Units on a scale	Standard Deviation 0.51
Vehicle QD	Investigator's Static Global Assessment (ISGA) Score for the First Flare Period	Week 4	2.2 Units on a scale	Standard Deviation 0.45
Vehicle QD	Investigator's Static Global Assessment (ISGA) Score for the First Flare Period	Week 8	2.1 Units on a scale	Standard Deviation 0.33
Vehicle QD	Investigator's Static Global Assessment (ISGA) Score for the First Flare Period	Week 12	2.3 Units on a scale	Standard Deviation 0.48
Crisaborole 2% QD	Investigator's Static Global Assessment (ISGA) Score for the First Flare Period	Week 12	2.5 Units on a scale	Standard Deviation 0.52
Crisaborole 2% QD	Investigator's Static Global Assessment (ISGA) Score for the First Flare Period	Week 0	2.3 Units on a scale	Standard Deviation 0.47
Crisaborole 2% QD	Investigator's Static Global Assessment (ISGA) Score for the First Flare Period	Week 8	2.4 Units on a scale	Standard Deviation 0.57
Crisaborole 2% QD	Investigator's Static Global Assessment (ISGA) Score for the First Flare Period	Week 4	2.2 Units on a scale	Standard Deviation 0.41

Secondary

Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period

MOS Sleep Scale is a 12-item measure that is segregated into subscales addressing seven sleep domains (i.e. sleep disturbance, snoring, short of breath or headache, adequacy of sleep, somnolence, sleep problems index I and sleep problems index II) and a single item assessing quantity of sleep. Quantity of sleep scores ranged from 0 to 24 (number of hours slept) and Optimal Sleep score ranged from 0 (no) to 1(yes) based on whether the participant slept for 7-8 hours per night, All other subscales including sleep problems index 1 and 2:were scored on a range of 0 to 100 where, higher scores=greater impairment. Observed scores for each individual sleep domain and quantity of sleep are reported in this outcome measure.

Time frame: Baseline (the last observation up to and including Day 1 of DB period),Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Week 32	34.2 Units on a scale	Standard Deviation 20.09
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Week 16	26.2 Units on a scale	Standard Deviation 12.87
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Baseline	35.5 Units on a scale	Standard Deviation 13.2
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Week 52	33.8 Units on a scale	Standard Deviation 14.86
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Week 20	24.8 Units on a scale	Standard Deviation 10.78
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Week 20	41.3 Units on a scale	Standard Deviation 19.62
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Week 48	33.7 Units on a scale	Standard Deviation 15.44
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Week 24	27.6 Units on a scale	Standard Deviation 15.88
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Week 24	8.0 Units on a scale	Standard Deviation 4.21
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Week 44	33.0 Units on a scale	Standard Deviation 18.97
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Week 28	27.8 Units on a scale	Standard Deviation 19.57
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Week 40	33.0 Units on a scale	Standard Deviation 15.07
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Week 40	33.7 Units on a scale	Standard Deviation 15.62
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Week 32	26.5 Units on a scale	Standard Deviation 12.76
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Week 16	37.1 Units on a scale	Standard Deviation 16
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Week 36	33.5 Units on a scale	Standard Deviation 19.04
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Week 36	25.9 Units on a scale	Standard Deviation 11.76
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Week 28	8.4 Units on a scale	Standard Deviation 5.2
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Week 32	33.5 Units on a scale	Standard Deviation 14.89
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Week 40	25.3 Units on a scale	Standard Deviation 12.37
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Week 12	32.2 Units on a scale	Standard Deviation 14.36
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Week 28	36.7 Units on a scale	Standard Deviation 18.79
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Week 44	28.9 Units on a scale	Standard Deviation 17.11
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Week 12	41.7 Units on a scale	Standard Deviation 18.86
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Week 24	32.1 Units on a scale	Standard Deviation 15.49
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Week 48	25.3 Units on a scale	Standard Deviation 11.67
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Week 32	9.2 Units on a scale	Standard Deviation 5.64
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Week 20	35.9 Units on a scale	Standard Deviation 17.75
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Week 52	26.3 Units on a scale	Standard Deviation 12.89
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Week 52	39.0 Units on a scale	Standard Deviation 16.6
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Week 16	33.9 Units on a scale	Standard Deviation 15.58
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Baseline	42.9 Units on a scale	Standard Deviation 26.41
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Week 44	32.4 Units on a scale	Standard Deviation 18.32
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Week 4	46.9 Units on a scale	Standard Deviation 27.17
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Week 8	36.5 Units on a scale	Standard Deviation 10.75
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Week 12	33.2 Units on a scale	Standard Deviation 14.4
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Week 8	47.2 Units on a scale	Standard Deviation 26.25
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Week 36	6.9 Units on a scale	Standard Deviation 1.58
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Week 28	39.3 Units on a scale	Standard Deviation 22.69
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Week 12	45.6 Units on a scale	Standard Deviation 27.93
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Week 28	34.4 Units on a scale	Standard Deviation 18.22
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Week 24	32.2 Units on a scale	Standard Deviation 19.95
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Week 16	43.3 Units on a scale	Standard Deviation 24.96
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Week 4	32.6 Units on a scale	Standard Deviation 11.7
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Week 20	38.7 Units on a scale	Standard Deviation 22.89
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Week 20	41.9 Units on a scale	Standard Deviation 27.5
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Week 4	39.6 Units on a scale	Standard Deviation 15.23
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Week 16	38.6 Units on a scale	Standard Deviation 19.44
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Week 24	50.3 Units on a scale	Standard Deviation 27.74
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Week 40	8.1 Units on a scale	Standard Deviation 4.39
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Week 12	35.1 Units on a scale	Standard Deviation 16.2
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Week 28	45.6 Units on a scale	Standard Deviation 28.95
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Week 16	32.1 Units on a scale	Standard Deviation 14.44
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Week 8	32.9 Units on a scale	Standard Deviation 13.8
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Week 32	42.4 Units on a scale	Standard Deviation 24.5
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Baseline	40.3 Units on a scale	Standard Deviation 17.05
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Week 4	33.7 Units on a scale	Standard Deviation 15.01
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Week 36	37.6 Units on a scale	Standard Deviation 21.07
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Week 44	7.1 Units on a scale	Standard Deviation 2.04
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Baseline	38.3 Units on a scale	Standard Deviation 18.74
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Week 40	44.1 Units on a scale	Standard Deviation 26.87
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Week 48	41.3 Units on a scale	Standard Deviation 15.4
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Week 52	45.6 Units on a scale	Standard Deviation 23.41
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Week 44	36.7 Units on a scale	Standard Deviation 24.97
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Week 52	70.0 Units on a scale	Standard Deviation 20.48
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Week 48	44.0 Units on a scale	Standard Deviation 22.53
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Baseline	8.3 Units on a scale	Standard Deviation 3.79
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Week 48	73.0 Units on a scale	Standard Deviation 18.96
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Week 8	31.4 Units on a scale	Standard Deviation 10.7
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Week 48	7.6 Units on a scale	Standard Deviation 3.88
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Week 48	33.3 Units on a scale	Standard Deviation 15.06
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Week 44	72.2 Units on a scale	Standard Deviation 22.9
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Week 52	7.7 Units on a scale	Standard Deviation 4.3
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Week 8	29.6 Units on a scale	Standard Deviation 10.77
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Week 40	68.5 Units on a scale	Standard Deviation 21.34
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Baseline	0.5 Units on a scale	Standard Deviation 0.5
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Week 44	39.3 Units on a scale	Standard Deviation 17.84
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Week 4	0.6 Units on a scale	Standard Deviation 0.5
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Week 52	32.4 Units on a scale	Standard Deviation 13.92
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Week 36	74.1 Units on a scale	Standard Deviation 22.38
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Week 8	0.7 Units on a scale	Standard Deviation 0.47
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Week 32	31.7 Units on a scale	Standard Deviation 14.1
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Week 32	74.7 Units on a scale	Standard Deviation 21.21
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Week 12	0.4 Units on a scale	Standard Deviation 0.5
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Week 40	38.6 Units on a scale	Standard Deviation 17.96
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Week 28	71.7 Units on a scale	Standard Deviation 22.03
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Week 16	0.5 Units on a scale	Standard Deviation 0.5
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Week 36	34.9 Units on a scale	Standard Deviation 17.41
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Week 24	71.6 Units on a scale	Standard Deviation 21.02
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Week 20	0.7 Units on a scale	Standard Deviation 0.46
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Week 24	30.9 Units on a scale	Standard Deviation 14.92
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Week 20	70.5 Units on a scale	Standard Deviation 21.56
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Week 24	0.4 Units on a scale	Standard Deviation 0.5
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Week 4	8.9 Units on a scale	Standard Deviation 4.55
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Week 16	73.3 Units on a scale	Standard Deviation 20.2
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Week 28	0.4 Units on a scale	Standard Deviation 0.51
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Week 4	31.4 Units on a scale	Standard Deviation 13.22
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Week 12	71.9 Units on a scale	Standard Deviation 22.92
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Week 32	0.5 Units on a scale	Standard Deviation 0.51
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Week 32	43.7 Units on a scale	Standard Deviation 21.16
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Week 8	72.5 Units on a scale	Standard Deviation 16.45
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Week 36	0.5 Units on a scale	Standard Deviation 0.51
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Week 8	8.1 Units on a scale	Standard Deviation 3.31
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Week 4	70.6 Units on a scale	Standard Deviation 20.15
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Week 40	0.5 Units on a scale	Standard Deviation 0.51
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Week 12	8.8 Units on a scale	Standard Deviation 4.46
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Baseline	68.6 Units on a scale	Standard Deviation 18.25
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Week 44	0.6 Units on a scale	Standard Deviation 0.51
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Week 36	31.4 Units on a scale	Standard Deviation 18.11
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Week 52	35.9 Units on a scale	Standard Deviation 19.59
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Week 48	0.6 Units on a scale	Standard Deviation 0.5
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Week 28	44.4 Units on a scale	Standard Deviation 21.57
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Week 48	36.3 Units on a scale	Standard Deviation 18.59
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Week 52	0.4 Units on a scale	Standard Deviation 0.49
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Week 16	8.2 Units on a scale	Standard Deviation 3.89
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Week 44	32.9 Units on a scale	Standard Deviation 23.13
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Baseline	24.1 Units on a scale	Standard Deviation 9.44
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Week 20	34.0 Units on a scale	Standard Deviation 16.21
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Week 4	23.8 Units on a scale	Standard Deviation 11.85
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Week 24	39.5 Units on a scale	Standard Deviation 17.02
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Week 40	34.7 Units on a scale	Standard Deviation 18.96
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Week 8	24.4 Units on a scale	Standard Deviation 10.81
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Week 20	6.9 Units on a scale	Standard Deviation 1.28
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Week 36	38.2 Units on a scale	Standard Deviation 23.61
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Week 12	25.0 Units on a scale	Standard Deviation 10.16
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Baseline	33.4 Units on a scale	Standard Deviation 12.63
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Week 16	31.8 Units on a scale	Standard Deviation 12.14
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Week 20	32.9 Units on a scale	Standard Deviation 13.01
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Week 24	34.6 Units on a scale	Standard Deviation 13.63
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Week 28	32.9 Units on a scale	Standard Deviation 13.74
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Week 32	30.5 Units on a scale	Standard Deviation 11.72
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Week 36	31.6 Units on a scale	Standard Deviation 12.86
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Week 40	33.7 Units on a scale	Standard Deviation 13.55
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Week 44	33.5 Units on a scale	Standard Deviation 13.25
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Week 8	7.8 Units on a scale	Standard Deviation 3.72
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Week 48	32.0 Units on a scale	Standard Deviation 12.2
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Week 52	32.6 Units on a scale	Standard Deviation 14.08
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Baseline	7.5 Units on a scale	Standard Deviation 2.42
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Week 4	8.1 Units on a scale	Standard Deviation 3.32
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Week 12	7.5 Units on a scale	Standard Deviation 3.18
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Week 16	8.1 Units on a scale	Standard Deviation 4.35
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Week 20	7.3 Units on a scale	Standard Deviation 1.49
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Week 24	8.0 Units on a scale	Standard Deviation 4.33
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Week 28	7.2 Units on a scale	Standard Deviation 1.38
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Week 32	8.3 Units on a scale	Standard Deviation 3.7
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Baseline	34.4 Units on a scale	Standard Deviation 14.17
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Week 36	7.2 Units on a scale	Standard Deviation 1.48
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Week 40	8.1 Units on a scale	Standard Deviation 3.92
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Week 44	6.7 Units on a scale	Standard Deviation 0.99
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Week 4	32.1 Units on a scale	Standard Deviation 11.57
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Week 48	7.7 Units on a scale	Standard Deviation 3.06
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Week 52	7.7 Units on a scale	Standard Deviation 3.12
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Baseline	0.6 Units on a scale	Standard Deviation 0.5
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Week 4	0.6 Units on a scale	Standard Deviation 0.5
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Week 8	0.6 Units on a scale	Standard Deviation 0.49
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Week 12	0.6 Units on a scale	Standard Deviation 0.5
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Week 16	0.6 Units on a scale	Standard Deviation 0.5
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Week 20	0.5 Units on a scale	Standard Deviation 0.51
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Week 24	0.5 Units on a scale	Standard Deviation 0.51
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Week 28	0.5 Units on a scale	Standard Deviation 0.51
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Week 32	0.6 Units on a scale	Standard Deviation 0.5
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Week 36	0.6 Units on a scale	Standard Deviation 0.51
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Week 40	0.4 Units on a scale	Standard Deviation 0.49
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Week 44	0.7 Units on a scale	Standard Deviation 0.47
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Week 48	0.4 Units on a scale	Standard Deviation 0.5
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Week 52	0.5 Units on a scale	Standard Deviation 0.51
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Baseline	27.2 Units on a scale	Standard Deviation 15.45
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Week 4	23.9 Units on a scale	Standard Deviation 9.81
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Week 8	25.2 Units on a scale	Standard Deviation 12.66
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Week 12	26.5 Units on a scale	Standard Deviation 13.16
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Week 16	25.0 Units on a scale	Standard Deviation 11.11
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Week 20	29.5 Units on a scale	Standard Deviation 18.57
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Week 24	27.7 Units on a scale	Standard Deviation 13.55
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Week 28	29.4 Units on a scale	Standard Deviation 18.86
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Week 32	23.1 Units on a scale	Standard Deviation 10.41
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Week 36	23.5 Units on a scale	Standard Deviation 14.55
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Week 40	26.0 Units on a scale	Standard Deviation 13.13
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Week 44	27.1 Units on a scale	Standard Deviation 14.04
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Week 48	26.5 Units on a scale	Standard Deviation 14.29
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Week 52	27.0 Units on a scale	Standard Deviation 12.25
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Baseline	37.2 Units on a scale	Standard Deviation 23.4
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Week 4	36.5 Units on a scale	Standard Deviation 21.43
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Week 8	36.8 Units on a scale	Standard Deviation 22.99
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Week 12	34.7 Units on a scale	Standard Deviation 21.12
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Week 16	35.0 Units on a scale	Standard Deviation 20.15
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Week 20	30.5 Units on a scale	Standard Deviation 17.46
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Week 24	39.6 Units on a scale	Standard Deviation 24.13
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Week 28	31.8 Units on a scale	Standard Deviation 21.28
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Week 32	39.1 Units on a scale	Standard Deviation 22.55
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Week 36	31.8 Units on a scale	Standard Deviation 18.79
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Week 40	37.4 Units on a scale	Standard Deviation 21.52
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Week 44	34.1 Units on a scale	Standard Deviation 19.7
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Week 48	37.2 Units on a scale	Standard Deviation 23.74
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Week 52	37.2 Units on a scale	Standard Deviation 22.07
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Baseline	34.8 Units on a scale	Standard Deviation 17.51
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Week 4	32.2 Units on a scale	Standard Deviation 14.92
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Week 8	35.3 Units on a scale	Standard Deviation 15.7
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Week 12	32.8 Units on a scale	Standard Deviation 16.9
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Week 16	30.8 Units on a scale	Standard Deviation 15.43
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Week 20	32.1 Units on a scale	Standard Deviation 13.85
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Week 24	36.3 Units on a scale	Standard Deviation 18.02
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Week 28	37.2 Units on a scale	Standard Deviation 16.4
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Week 8	33.1 Units on a scale	Standard Deviation 13.16
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Week 12	33.2 Units on a scale	Standard Deviation 13.21
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Week 16	32.0 Units on a scale	Standard Deviation 11.95
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Week 20	33.1 Units on a scale	Standard Deviation 11.87
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Week 24	35.9 Units on a scale	Standard Deviation 13.54
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Week 28	35.0 Units on a scale	Standard Deviation 13.07
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Week 32	31.6 Units on a scale	Standard Deviation 11.07
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Week 36	32.2 Units on a scale	Standard Deviation 12.2
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Week 40	33.9 Units on a scale	Standard Deviation 12.86
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Week 44	36.9 Units on a scale	Standard Deviation 13.73
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Week 48	32.9 Units on a scale	Standard Deviation 12.13
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Week 52	33.0 Units on a scale	Standard Deviation 13.66
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Week 32	32.0 Units on a scale	Standard Deviation 14.2
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Week 36	32.2 Units on a scale	Standard Deviation 16.82
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Week 40	33.0 Units on a scale	Standard Deviation 16.83
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Week 44	38.9 Units on a scale	Standard Deviation 16.87
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Week 48	32.1 Units on a scale	Standard Deviation 16.29
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Week 52	32.9 Units on a scale	Standard Deviation 17.59
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Baseline	69.1 Units on a scale	Standard Deviation 21.69
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Week 4	71.6 Units on a scale	Standard Deviation 18.8
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Week 8	72.6 Units on a scale	Standard Deviation 20.58
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Week 12	68.2 Units on a scale	Standard Deviation 21.47
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Week 16	69.0 Units on a scale	Standard Deviation 18.71
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Week 20	67.6 Units on a scale	Standard Deviation 17.86
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Week 24	67.4 Units on a scale	Standard Deviation 20.59
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Week 28	71.2 Units on a scale	Standard Deviation 21.47
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Week 32	72.4 Units on a scale	Standard Deviation 19.67
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Week 36	68.8 Units on a scale	Standard Deviation 15.76
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Week 40	69.1 Units on a scale	Standard Deviation 18.51
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Week 44	70.0 Units on a scale	Standard Deviation 21.79
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Week 48	70.2 Units on a scale	Standard Deviation 19.7
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Week 52	68.6 Units on a scale	Standard Deviation 22.74
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Baseline	41.8 Units on a scale	Standard Deviation 18.51
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Week 4	42.4 Units on a scale	Standard Deviation 18.13
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Week 8	40.1 Units on a scale	Standard Deviation 18.78
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Week 12	40.4 Units on a scale	Standard Deviation 18.48
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Week 16	39.1 Units on a scale	Standard Deviation 17.06
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Week 20	37.5 Units on a scale	Standard Deviation 17.82
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Week 24	43.4 Units on a scale	Standard Deviation 18.06
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Week 28	41.2 Units on a scale	Standard Deviation 19.33
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Week 32	41.5 Units on a scale	Standard Deviation 15.63
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Week 36	39.2 Units on a scale	Standard Deviation 14.7
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Week 40	43.3 Units on a scale	Standard Deviation 14.7
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Week 44	44.3 Units on a scale	Standard Deviation 16.99
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Week 48	42.3 Units on a scale	Standard Deviation 13.48
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Week 52	40.0 Units on a scale	Standard Deviation 14.47
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Baseline	33.2 Units on a scale	Standard Deviation 14.19
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Week 4	31.6 Units on a scale	Standard Deviation 11.53
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Week 8	31.5 Units on a scale	Standard Deviation 13.98
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Week 12	33.3 Units on a scale	Standard Deviation 12.89
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Week 48	36.8 Units on a scale	Standard Deviation 13.82
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Week 16	22.9 Units on a scale	Standard Deviation 9.56
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Week 36	35.2 Units on a scale	Standard Deviation 12
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Week 52	32.2 Units on a scale	Standard Deviation 10.53
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Week 12	28.1 Units on a scale	Standard Deviation 15.95
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Week 20	40.0 Units on a scale	Standard Deviation 18.14
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Week 32	33.6 Units on a scale	Standard Deviation 10.53
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Week 8	27.4 Units on a scale	Standard Deviation 17.03
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Week 16	8.4 Units on a scale	Standard Deviation 3.8
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Week 36	45.9 Units on a scale	Standard Deviation 21.67
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Week 4	27.1 Units on a scale	Standard Deviation 13.16
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Week 16	34.0 Units on a scale	Standard Deviation 9.92
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Week 40	33.9 Units on a scale	Standard Deviation 16.91
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Week 52	0.4 Units on a scale	Standard Deviation 0.51
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Week 24	39.0 Units on a scale	Standard Deviation 16.71
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Week 44	43.3 Units on a scale	Standard Deviation 19.7
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Week 48	0.3 Units on a scale	Standard Deviation 0.49
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Week 12	7.7 Units on a scale	Standard Deviation 2.89
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Week 48	34.9 Units on a scale	Standard Deviation 18.61
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Week 44	0.2 Units on a scale	Standard Deviation 0.4
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Week 32	35.1 Units on a scale	Standard Deviation 13.92
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Week 52	28.1 Units on a scale	Standard Deviation 9.24
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Week 40	0.1 Units on a scale	Standard Deviation 0.35
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Week 28	46.7 Units on a scale	Standard Deviation 17.15
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Week 36	0.7 Units on a scale	Standard Deviation 0.49
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Week 4	6.9 Units on a scale	Standard Deviation 1.92
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Week 4	68.4 Units on a scale	Standard Deviation 19.53
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Week 32	0.3 Units on a scale	Standard Deviation 0.48
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Week 12	34.1 Units on a scale	Standard Deviation 13.03
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Week 8	66.1 Units on a scale	Standard Deviation 24.11
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Week 28	0.6 Units on a scale	Standard Deviation 0.51
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Week 32	48.2 Units on a scale	Standard Deviation 17.46
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Week 12	70.9 Units on a scale	Standard Deviation 20.69
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Week 24	0.5 Units on a scale	Standard Deviation 0.52
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Week 52	31.6 Units on a scale	Standard Deviation 9.91
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Week 16	71.4 Units on a scale	Standard Deviation 16.52
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Week 20	0.6 Units on a scale	Standard Deviation 0.5
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Week 4	35.6 Units on a scale	Standard Deviation 13.51
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Week 20	75.5 Units on a scale	Standard Deviation 16.35
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Week 16	0.6 Units on a scale	Standard Deviation 0.51
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Week 36	45.7 Units on a scale	Standard Deviation 24.77
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Week 24	70.7 Units on a scale	Standard Deviation 18.17
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Week 12	0.6 Units on a scale	Standard Deviation 0.5
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Week 8	7.9 Units on a scale	Standard Deviation 3.19
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Week 28	64.3 Units on a scale	Standard Deviation 19.89
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Week 8	0.5 Units on a scale	Standard Deviation 0.51
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Week 28	37.9 Units on a scale	Standard Deviation 13.18
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Week 32	64.6 Units on a scale	Standard Deviation 23.67
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Optimal Hours Slept Score: Week 4	0.5 Units on a scale	Standard Deviation 0.5
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Week 40	41.7 Units on a scale	Standard Deviation 25.88
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Week 36	62.9 Units on a scale	Standard Deviation 25.63
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Week 52	7.5 Units on a scale	Standard Deviation 4.93
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Week 48	34.4 Units on a scale	Standard Deviation 11.66
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Week 40	67.5 Units on a scale	Standard Deviation 23.15
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Week 48	8.2 Units on a scale	Standard Deviation 5.29
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Week 20	29.7 Units on a scale	Standard Deviation 7.67
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Week 44	60.9 Units on a scale	Standard Deviation 21.19
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Week 44	34.5 Units on a scale	Standard Deviation 20.18
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Week 4	38.2 Units on a scale	Standard Deviation 14.53
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Week 48	38.3 Units on a scale	Standard Deviation 21.67
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Week 40	32.5 Units on a scale	Standard Deviation 14.88
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Week 44	50.3 Units on a scale	Standard Deviation 26.89
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Week 52	37.3 Units on a scale	Standard Deviation 19.81
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Week 36	40.0 Units on a scale	Standard Deviation 25.82
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Week 48	65.8 Units on a scale	Standard Deviation 19.75
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Week 32	24.6 Units on a scale	Standard Deviation 16.64
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Week 44	8.7 Units on a scale	Standard Deviation 5.44
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Week 4	41.6 Units on a scale	Standard Deviation 19.69
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Week 28	32.9 Units on a scale	Standard Deviation 21.64
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Week 44	38.5 Units on a scale	Standard Deviation 14.86
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Week 8	39.8 Units on a scale	Standard Deviation 20.46
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Week 24	32.9 Units on a scale	Standard Deviation 20.16
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Adequacy Score: Week 52	68.0 Units on a scale	Standard Deviation 18.97
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Week 12	38.8 Units on a scale	Standard Deviation 15.51
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Week 20	38.2 Units on a scale	Standard Deviation 26.01
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Week 40	10.0 Units on a scale	Standard Deviation 6.23
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Week 16	40.8 Units on a scale	Standard Deviation 16.03
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Week 16	44.8 Units on a scale	Standard Deviation 28.22
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Week 8	36.1 Units on a scale	Standard Deviation 16.52
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Week 20	36.0 Units on a scale	Standard Deviation 11.92
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Week 12	40.0 Units on a scale	Standard Deviation 23.83
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Week 36	7.4 Units on a scale	Standard Deviation 0.98
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Week 24	35.8 Units on a scale	Standard Deviation 13.29
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Week 8	46.8 Units on a scale	Standard Deviation 28.77
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Week 48	46.1 Units on a scale	Standard Deviation 23.52
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Disturbance Score: Week 28	38.5 Units on a scale	Standard Deviation 13.2
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Week 4	44.8 Units on a scale	Standard Deviation 20.87
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Week 8	38.5 Units on a scale	Standard Deviation 17.14
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Snoring Score: Week 4	41.2 Units on a scale	Standard Deviation 25.74
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Week 32	7.8 Units on a scale	Standard Deviation 4.25
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Week 12	36.4 Units on a scale	Standard Deviation 13.26
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Week 52	25.3 Units on a scale	Standard Deviation 11.87
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Week 40	34.6 Units on a scale	Standard Deviation 17.27
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Week 16	36.8 Units on a scale	Standard Deviation 11.34
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Week 48	26.7 Units on a scale	Standard Deviation 13.03
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Week 8	46.7 Units on a scale	Standard Deviation 21.81
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Week 20	32.0 Units on a scale	Standard Deviation 8.63
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Week 44	25.5 Units on a scale	Standard Deviation 12.93
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Week 28	7.9 Units on a scale	Standard Deviation 2.98
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Week 24	33.8 Units on a scale	Standard Deviation 11.25
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Week 40	30.0 Units on a scale	Standard Deviation 21.38
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index I Score: Week 24	30.7 Units on a scale	Standard Deviation 9.71
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Week 28	38.8 Units on a scale	Standard Deviation 11.64
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Week 36	22.9 Units on a scale	Standard Deviation 7.56
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Week 12	43.8 Units on a scale	Standard Deviation 21.15
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Week 32	36.3 Units on a scale	Standard Deviation 12.86
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Week 32	29.2 Units on a scale	Standard Deviation 15.53
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Week 24	8.3 Units on a scale	Standard Deviation 2.13
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Week 36	40.7 Units on a scale	Standard Deviation 14.56
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Week 28	30.0 Units on a scale	Standard Deviation 15.19
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Week 52	44.4 Units on a scale	Standard Deviation 20.57
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Week 40	34.8 Units on a scale	Standard Deviation 16.31
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Week 24	25.7 Units on a scale	Standard Deviation 12.22
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Somnolence Score: Week 16	47.0 Units on a scale	Standard Deviation 18.07
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Sleep Problems Index II Score: Week 44	41.7 Units on a scale	Standard Deviation 15.83
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Short of Breath or Headache score: Week 20	23.6 Units on a scale	Standard Deviation 12.06
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	Quantity Hours Slept Score: Week 20	8.9 Units on a scale	Standard Deviation 3.83

Secondary

Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period

Time frame: Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Short of Breath or Headache score: Week 44	22.9 Units on a scale	Standard Deviation 7.56
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Adequacy Score: Week 4	71.0 Units on a scale	Standard Deviation 20.74
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index II Score: Baseline	35.5 Units on a scale	Standard Deviation 13.2
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Adequacy Score: Week 8	72.8 Units on a scale	Standard Deviation 17.2
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Optimal Hours Slept Score: Week 12	0.4 Units on a scale	Standard Deviation 0.5
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Adequacy Score: Week 12	75.0 Units on a scale	Standard Deviation 20.9
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index II Score: Week 4	32.8 Units on a scale	Standard Deviation 12
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Adequacy Score: Week 16	74.7 Units on a scale	Standard Deviation 20.65
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Short of Breath or Headache score: Week 48	22.4 Units on a scale	Standard Deviation 6.64
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Adequacy Score: Week 20	70.0 Units on a scale	Standard Deviation 22.68
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index II Score: Week 8	30.3 Units on a scale	Standard Deviation 10.27
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Adequacy Score: Week 24	76.5 Units on a scale	Standard Deviation 16.18
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Optimal Hours Slept Score: Week 28	0.7 Units on a scale	Standard Deviation 0.49
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Adequacy Score: Week 28	70.0 Units on a scale	Standard Deviation 19.15
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index II Score: Week 12	30.5 Units on a scale	Standard Deviation 12.7
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Adequacy Score: Week 32	78.8 Units on a scale	Standard Deviation 14.55
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Short of Breath or Headache score: Week 52	22.7 Units on a scale	Standard Deviation 7.04
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Adequacy Score: Week 36	75.0 Units on a scale	Standard Deviation 15.17
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index II Score: Week 16	31.2 Units on a scale	Standard Deviation 12.9
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Adequacy Score: Week 40	72.9 Units on a scale	Standard Deviation 16.11
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Snoring Score: Week 8	49.6 Units on a scale	Standard Deviation 26.53
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Adequacy Score: Week 44	67.1 Units on a scale	Standard Deviation 26.28
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Short of Breath or Headache score: Week 16	24.2 Units on a scale	Standard Deviation 8.38
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Adequacy Score: Week 48	75.3 Units on a scale	Standard Deviation 14.63
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Snoring Score: Week 12	49.0 Units on a scale	Standard Deviation 28.64
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Adequacy Score: Week 52	74.7 Units on a scale	Standard Deviation 13.56
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Snoring Score: Baseline	42.9 Units on a scale	Standard Deviation 26.41
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Somnolence Score: Baseline	40.3 Units on a scale	Standard Deviation 17.05
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Snoring Score: Week 16	45.3 Units on a scale	Standard Deviation 27.36
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Somnolence Score: Week 4	40.0 Units on a scale	Standard Deviation 15.56
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Optimal Hours Slept Score: Baseline	0.5 Units on a scale	Standard Deviation 0.5
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Somnolence Score: Week 8	36.3 Units on a scale	Standard Deviation 10.55
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Snoring Score: Week 20	42.5 Units on a scale	Standard Deviation 27.12
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Somnolence Score: Week 12	38.0 Units on a scale	Standard Deviation 14.03
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Snoring Score: Week 4	47.3 Units on a scale	Standard Deviation 27.53
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Somnolence Score: Week 16	34.4 Units on a scale	Standard Deviation 10
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Snoring Score: Week 24	54.1 Units on a scale	Standard Deviation 26.23
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Somnolence Score: Week 20	42.5 Units on a scale	Standard Deviation 24.67
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Short of Breath or Headache score: Week 20	22.5 Units on a scale	Standard Deviation 7.07
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Somnolence Score: Week 24	39.6 Units on a scale	Standard Deviation 16.07
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Snoring Score: Week 28	48.6 Units on a scale	Standard Deviation 30.24
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Somnolence Score: Week 28	48.6 Units on a scale	Standard Deviation 24.26
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Optimal Hours Slept Score: Week 16	0.5 Units on a scale	Standard Deviation 0.51
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Somnolence Score: Week 32	44.6 Units on a scale	Standard Deviation 20.76
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Snoring Score: Week 32	40.0 Units on a scale	Standard Deviation 19.32
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Somnolence Score: Week 36	35.6 Units on a scale	Standard Deviation 19.63
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Optimal Hours Slept Score: Week 32	0.6 Units on a scale	Standard Deviation 0.5
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Somnolence Score: Week 40	36.1 Units on a scale	Standard Deviation 16.51
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Somnolence Score: Week 44	37.1 Units on a scale	Standard Deviation 16.71
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Snoring Score: Week 36	36.7 Units on a scale	Standard Deviation 15.06
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Somnolence Score: Week 48	39.6 Units on a scale	Standard Deviation 14.62
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Short of Breath or Headache score: Week 24	24.7 Units on a scale	Standard Deviation 11.25
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Somnolence Score: Week 52	38.7 Units on a scale	Standard Deviation 13.14
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Snoring Score: Week 40	44.7 Units on a scale	Standard Deviation 26.01
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index I Score: Baseline	33.4 Units on a scale	Standard Deviation 12.63
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Optimal Hours Slept Score: Week 36	0.7 Units on a scale	Standard Deviation 0.52
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index I Score: Week 4	31.4 Units on a scale	Standard Deviation 13.64
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Snoring Score: Week 44	28.6 Units on a scale	Standard Deviation 10.69
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index I Score: Week 8	28.9 Units on a scale	Standard Deviation 10.79
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Optimal Hours Slept Score: Week 8	0.7 Units on a scale	Standard Deviation 0.46
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index I Score: Week 12	29.3 Units on a scale	Standard Deviation 13.27
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Snoring Score: Week 48	44.7 Units on a scale	Standard Deviation 16.63
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index I Score: Week 16	30.2 Units on a scale	Standard Deviation 11.78
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Optimal Hours Slept Score: Week 40	0.5 Units on a scale	Standard Deviation 0.51
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index I Score: Week 20	32.5 Units on a scale	Standard Deviation 12.05
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Snoring Score: Week 52	46.7 Units on a scale	Standard Deviation 20.93
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index I Score: Week 24	28.0 Units on a scale	Standard Deviation 12.25
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Short of Breath or Headache score: Week 28	31.4 Units on a scale	Standard Deviation 22.68
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index I Score: Week 28	35.7 Units on a scale	Standard Deviation 13.97
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Disturbance Score: Baseline	38.3 Units on a scale	Standard Deviation 18.74
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index I Score: Week 32	29.2 Units on a scale	Standard Deviation 8.39
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Optimal Hours Slept Score: Week 44	0.6 Units on a scale	Standard Deviation 0.53
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index I Score: Week 36	28.3 Units on a scale	Standard Deviation 9.83
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Disturbance Score: Week 4	34.3 Units on a scale	Standard Deviation 15.11
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index I Score: Week 40	30.8 Units on a scale	Standard Deviation 11.15
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Optimal Hours Slept Score: Week 20	0.6 Units on a scale	Standard Deviation 0.52
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index I Score: Week 44	29.5 Units on a scale	Standard Deviation 11.93
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Disturbance Score: Week 8	31.7 Units on a scale	Standard Deviation 12
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index I Score: Week 48	31.6 Units on a scale	Standard Deviation 10.74
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Optimal Hours Slept Score: Week 48	0.6 Units on a scale	Standard Deviation 0.51
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Disturbance Score: Week 12	33.3 Units on a scale	Standard Deviation 14.51
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index II Score: Week 20	33.2 Units on a scale	Standard Deviation 12.21
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Short of Breath or Headache score: Week 32	25.0 Units on a scale	Standard Deviation 8.94
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index II Score: Week 24	29.6 Units on a scale	Standard Deviation 11.67
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Disturbance Score: Week 16	35.9 Units on a scale	Standard Deviation 17.17
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index II Score: Week 28	36.9 Units on a scale	Standard Deviation 12.41
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Optimal Hours Slept Score: Week 52	0.4 Units on a scale	Standard Deviation 0.51
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index II Score: Week 32	30.9 Units on a scale	Standard Deviation 8.47
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Disturbance Score: Week 20	32.8 Units on a scale	Standard Deviation 12.22
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index II Score: Week 36	27.9 Units on a scale	Standard Deviation 8.99
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Optimal Hours Slept Score: Week 4	0.6 Units on a scale	Standard Deviation 0.5
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index II Score: Week 40	31.3 Units on a scale	Standard Deviation 10
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Disturbance Score: Week 24	30.7 Units on a scale	Standard Deviation 15.9
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index II Score: Week 44	28.1 Units on a scale	Standard Deviation 9.82
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Short of Breath or Headache score: Baseline	24.1 Units on a scale	Standard Deviation 9.44
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index II Score: Week 48	31.4 Units on a scale	Standard Deviation 9.57
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Disturbance Score: Week 28	37.3 Units on a scale	Standard Deviation 11.78
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index II Score: Week 52	30.6 Units on a scale	Standard Deviation 8.85
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Short of Breath or Headache score: Week 36	20.0 Units on a scale	Standard Deviation 0
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Quantity Hours Slept Score: Baseline	8.3 Units on a scale	Standard Deviation 3.79
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Disturbance Score: Week 32	31.4 Units on a scale	Standard Deviation 14.75
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Quantity Hours Slept Score: Week 4	9.0 Units on a scale	Standard Deviation 4.68
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Short of Breath or Headache score: Week 4	24.0 Units on a scale	Standard Deviation 12.21
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Quantity Hours Slept Score: Week 8	8.5 Units on a scale	Standard Deviation 3.77
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Disturbance Score: Week 36	27.7 Units on a scale	Standard Deviation 9.43
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Quantity Hours Slept Score: Week 12	8.6 Units on a scale	Standard Deviation 4.15
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Short of Breath or Headache score: Week 40	22.4 Units on a scale	Standard Deviation 6.64
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Quantity Hours Slept Score: Week 16	8.5 Units on a scale	Standard Deviation 4.11
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Disturbance Score: Week 40	34.3 Units on a scale	Standard Deviation 14.8
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Quantity Hours Slept Score: Week 20	7.0 Units on a scale	Standard Deviation 1.2
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Short of Breath or Headache score: Week 8	24.8 Units on a scale	Standard Deviation 10.46
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Quantity Hours Slept Score: Week 24	7.2 Units on a scale	Standard Deviation 1.99
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Disturbance Score: Week 44	23.9 Units on a scale	Standard Deviation 10.47
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Quantity Hours Slept Score: Week 28	6.9 Units on a scale	Standard Deviation 1.07
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Optimal Hours Slept Score: Week 24	0.5 Units on a scale	Standard Deviation 0.51
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Quantity Hours Slept Score: Week 32	8.5 Units on a scale	Standard Deviation 4.24
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Disturbance Score: Week 48	33.9 Units on a scale	Standard Deviation 11.81
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Quantity Hours Slept Score: Week 36	7.0 Units on a scale	Standard Deviation 0.89
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Short of Breath or Headache score: Week 12	23.0 Units on a scale	Standard Deviation 7.33
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Quantity Hours Slept Score: Week 40	8.3 Units on a scale	Standard Deviation 4.57
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Disturbance Score: Week 52	32.4 Units on a scale	Standard Deviation 16.27
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Quantity Hours Slept Score: Week 44	6.7 Units on a scale	Standard Deviation 1.11
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index I Score: Week 52	30.2 Units on a scale	Standard Deviation 9.13
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Quantity Hours Slept Score: Week 48	7.2 Units on a scale	Standard Deviation 1.63
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Quantity Hours Slept Score: Week 52	8.0 Units on a scale	Standard Deviation 4.57
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Adequacy Score: Baseline	68.6 Units on a scale	Standard Deviation 18.25
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Quantity Hours Slept Score: Week 48	7.2 Units on a scale	Standard Deviation 1.46
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Short of Breath or Headache score: Week 36	20.0 Units on a scale	Standard Deviation 0
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Somnolence Score: Week 40	43.1 Units on a scale	Standard Deviation 15.35
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Short of Breath or Headache score: Week 12	26.0 Units on a scale	Standard Deviation 12.97
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Optimal Hours Slept Score: Baseline	0.6 Units on a scale	Standard Deviation 0.5
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Optimal Hours Slept Score: Week 4	0.6 Units on a scale	Standard Deviation 0.5
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Optimal Hours Slept Score: Week 8	0.6 Units on a scale	Standard Deviation 0.49
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Optimal Hours Slept Score: Week 12	0.6 Units on a scale	Standard Deviation 0.5
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Optimal Hours Slept Score: Week 16	0.6 Units on a scale	Standard Deviation 0.5
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Optimal Hours Slept Score: Week 20	0.5 Units on a scale	Standard Deviation 0.52
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Optimal Hours Slept Score: Week 24	0.6 Units on a scale	Standard Deviation 0.5
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Short of Breath or Headache score: Week 16	24.9 Units on a scale	Standard Deviation 10.96
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Short of Breath or Headache score: Week 20	29.2 Units on a scale	Standard Deviation 17.54
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Short of Breath or Headache score: Week 24	26.5 Units on a scale	Standard Deviation 11.99
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Short of Breath or Headache score: Week 28	26.7 Units on a scale	Standard Deviation 14.14
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Short of Breath or Headache score: Week 32	22.2 Units on a scale	Standard Deviation 8.47
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Short of Breath or Headache score: Week 40	25.4 Units on a scale	Standard Deviation 12.08
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Short of Breath or Headache score: Week 44	28.9 Units on a scale	Standard Deviation 14.53
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Short of Breath or Headache score: Week 48	25.0 Units on a scale	Standard Deviation 12.16
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Short of Breath or Headache score: Week 52	27.8 Units on a scale	Standard Deviation 11.66
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Snoring Score: Baseline	37.2 Units on a scale	Standard Deviation 23.4
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Snoring Score: Week 4	36.5 Units on a scale	Standard Deviation 21.43
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Optimal Hours Slept Score: Week 28	0.6 Units on a scale	Standard Deviation 0.53
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Optimal Hours Slept Score: Week 32	0.7 Units on a scale	Standard Deviation 0.45
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Optimal Hours Slept Score: Week 36	0.9 Units on a scale	Standard Deviation 0.38
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Optimal Hours Slept Score: Week 40	0.5 Units on a scale	Standard Deviation 0.51
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Optimal Hours Slept Score: Week 44	0.9 Units on a scale	Standard Deviation 0.33
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Optimal Hours Slept Score: Week 48	0.4 Units on a scale	Standard Deviation 0.5
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Optimal Hours Slept Score: Week 52	0.5 Units on a scale	Standard Deviation 0.51
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Short of Breath or Headache score: Baseline	27.2 Units on a scale	Standard Deviation 15.45
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Short of Breath or Headache score: Week 4	23.9 Units on a scale	Standard Deviation 9.81
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Short of Breath or Headache score: Week 8	23.6 Units on a scale	Standard Deviation 9.9
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index I Score: Week 52	32.0 Units on a scale	Standard Deviation 13.62
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index II Score: Baseline	34.4 Units on a scale	Standard Deviation 14.17
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index II Score: Week 4	32.1 Units on a scale	Standard Deviation 11.57
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index II Score: Week 8	32.4 Units on a scale	Standard Deviation 13.36
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index II Score: Week 12	32.8 Units on a scale	Standard Deviation 13.47
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Snoring Score: Week 8	35.5 Units on a scale	Standard Deviation 22.77
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Snoring Score: Week 12	33.5 Units on a scale	Standard Deviation 20.95
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Snoring Score: Week 16	34.6 Units on a scale	Standard Deviation 19.8
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Snoring Score: Week 20	23.1 Units on a scale	Standard Deviation 7.51
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Snoring Score: Week 24	38.1 Units on a scale	Standard Deviation 22.72
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Snoring Score: Week 28	22.2 Units on a scale	Standard Deviation 6.67
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Snoring Score: Week 32	37.8 Units on a scale	Standard Deviation 21.72
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Snoring Score: Week 36	25.7 Units on a scale	Standard Deviation 9.76
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Snoring Score: Week 40	38.5 Units on a scale	Standard Deviation 21.85
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Snoring Score: Week 44	28.9 Units on a scale	Standard Deviation 14.53
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Snoring Score: Week 48	40.0 Units on a scale	Standard Deviation 24.32
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Snoring Score: Week 52	41.7 Units on a scale	Standard Deviation 21.67
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Disturbance Score: Baseline	34.8 Units on a scale	Standard Deviation 17.51
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Disturbance Score: Week 4	32.2 Units on a scale	Standard Deviation 14.92
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Disturbance Score: Week 8	35.1 Units on a scale	Standard Deviation 16.27
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Disturbance Score: Week 12	32.3 Units on a scale	Standard Deviation 17.12
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Disturbance Score: Week 16	30.6 Units on a scale	Standard Deviation 14.57
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Disturbance Score: Week 20	28.0 Units on a scale	Standard Deviation 9.31
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Disturbance Score: Week 24	35.9 Units on a scale	Standard Deviation 18.34
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Disturbance Score: Week 28	31.1 Units on a scale	Standard Deviation 12.43
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Disturbance Score: Week 32	32.3 Units on a scale	Standard Deviation 12.28
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Disturbance Score: Week 36	27.7 Units on a scale	Standard Deviation 10.93
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Disturbance Score: Week 40	33.2 Units on a scale	Standard Deviation 18.06
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Disturbance Score: Week 44	34.3 Units on a scale	Standard Deviation 16.25
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Disturbance Score: Week 48	30.2 Units on a scale	Standard Deviation 16.76
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Disturbance Score: Week 52	31.6 Units on a scale	Standard Deviation 15.29
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Adequacy Score: Baseline	69.1 Units on a scale	Standard Deviation 21.69
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Adequacy Score: Week 4	71.6 Units on a scale	Standard Deviation 18.8
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Adequacy Score: Week 8	73.2 Units on a scale	Standard Deviation 21.43
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Adequacy Score: Week 12	68.0 Units on a scale	Standard Deviation 21.74
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Adequacy Score: Week 16	66.5 Units on a scale	Standard Deviation 17.98
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Adequacy Score: Week 20	66.9 Units on a scale	Standard Deviation 21.36
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Adequacy Score: Week 24	68.1 Units on a scale	Standard Deviation 20.88
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Adequacy Score: Week 28	72.2 Units on a scale	Standard Deviation 28.19
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Adequacy Score: Week 32	74.4 Units on a scale	Standard Deviation 19.87
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Adequacy Score: Week 36	72.9 Units on a scale	Standard Deviation 17.99
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Adequacy Score: Week 40	68.1 Units on a scale	Standard Deviation 18.33
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Adequacy Score: Week 44	73.3 Units on a scale	Standard Deviation 26.46
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Adequacy Score: Week 48	72.9 Units on a scale	Standard Deviation 18.99
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Adequacy Score: Week 52	67.8 Units on a scale	Standard Deviation 23.35
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Somnolence Score: Baseline	41.8 Units on a scale	Standard Deviation 18.51
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Somnolence Score: Week 4	42.4 Units on a scale	Standard Deviation 18.13
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Somnolence Score: Week 8	39.1 Units on a scale	Standard Deviation 18.89
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Somnolence Score: Week 12	41.3 Units on a scale	Standard Deviation 18.81
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Somnolence Score: Week 16	40.5 Units on a scale	Standard Deviation 17.38
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Somnolence Score: Week 20	36.9 Units on a scale	Standard Deviation 20.66
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Somnolence Score: Week 24	42.8 Units on a scale	Standard Deviation 19.98
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Somnolence Score: Week 28	37.0 Units on a scale	Standard Deviation 20.03
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Somnolence Score: Week 32	42.5 Units on a scale	Standard Deviation 15.04
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Somnolence Score: Week 36	31.4 Units on a scale	Standard Deviation 9.2
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Somnolence Score: Week 44	40.7 Units on a scale	Standard Deviation 18.99
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Somnolence Score: Week 48	43.1 Units on a scale	Standard Deviation 13.04
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Somnolence Score: Week 52	39.1 Units on a scale	Standard Deviation 14.11
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index I Score: Baseline	33.2 Units on a scale	Standard Deviation 14.19
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index I Score: Week 4	31.6 Units on a scale	Standard Deviation 11.53
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index I Score: Week 8	30.7 Units on a scale	Standard Deviation 13.99
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index I Score: Week 12	33.2 Units on a scale	Standard Deviation 13.22
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index I Score: Week 16	32.6 Units on a scale	Standard Deviation 12.1
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index I Score: Week 20	31.8 Units on a scale	Standard Deviation 14.12
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index I Score: Week 24	34.4 Units on a scale	Standard Deviation 14.87
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index I Score: Week 28	28.5 Units on a scale	Standard Deviation 13.34
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index I Score: Week 32	30.5 Units on a scale	Standard Deviation 12.63
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index I Score: Week 36	26.2 Units on a scale	Standard Deviation 11.45
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index I Score: Week 40	34.4 Units on a scale	Standard Deviation 14.78
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index I Score: Week 44	30.7 Units on a scale	Standard Deviation 14.32
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index I Score: Week 48	31.0 Units on a scale	Standard Deviation 12.83
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index II Score: Week 16	32.7 Units on a scale	Standard Deviation 11.83
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index II Score: Week 20	31.1 Units on a scale	Standard Deviation 11.85
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index II Score: Week 24	35.4 Units on a scale	Standard Deviation 14.29
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index II Score: Week 28	30.9 Units on a scale	Standard Deviation 11.08
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index II Score: Week 32	31.5 Units on a scale	Standard Deviation 11.36
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index II Score: Week 36	27.5 Units on a scale	Standard Deviation 8.8
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index II Score: Week 40	34.3 Units on a scale	Standard Deviation 14.03
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index II Score: Week 44	33.8 Units on a scale	Standard Deviation 14.04
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index II Score: Week 48	31.6 Units on a scale	Standard Deviation 12.65
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Sleep Problems Index II Score: Week 52	32.4 Units on a scale	Standard Deviation 12.2
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Quantity Hours Slept Score: Baseline	7.5 Units on a scale	Standard Deviation 2.42
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Quantity Hours Slept Score: Week 4	8.1 Units on a scale	Standard Deviation 3.32
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Quantity Hours Slept Score: Week 8	7.9 Units on a scale	Standard Deviation 3.92
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Quantity Hours Slept Score: Week 12	7.6 Units on a scale	Standard Deviation 3.22
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Quantity Hours Slept Score: Week 16	8.5 Units on a scale	Standard Deviation 4.9
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Quantity Hours Slept Score: Week 20	7.7 Units on a scale	Standard Deviation 1.55
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Quantity Hours Slept Score: Week 24	7.4 Units on a scale	Standard Deviation 3.45
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Quantity Hours Slept Score: Week 28	7.4 Units on a scale	Standard Deviation 1.51
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Quantity Hours Slept Score: Week 32	7.6 Units on a scale	Standard Deviation 1.22
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Quantity Hours Slept Score: Week 36	8.0 Units on a scale	Standard Deviation 1.41
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Quantity Hours Slept Score: Week 40	7.5 Units on a scale	Standard Deviation 2.97
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Quantity Hours Slept Score: Week 44	7.1 Units on a scale	Standard Deviation 0.6
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	Quantity Hours Slept Score: Week 52	7.0 Units on a scale	Standard Deviation 1.24

Secondary

Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period

Time frame: Weeks 0, 4, 8 and 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Sleep Disturbance Score: Week 8	33.6 Units on a scale	Standard Deviation 12.81
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Optimal Hours Slept Score: Week 4	0.5 Units on a scale	Standard Deviation 0.51
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Sleep Disturbance Score: Week 12	43.3 Units on a scale	Standard Deviation 16.65
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Short of Breath or Headache score: Week 8	27.7 Units on a scale	Standard Deviation 15.36
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Sleep Adequacy Score: Week 0	67.0 Units on a scale	Standard Deviation 20.99
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Quantity Hours Slept Score: Week 12	8.0 Units on a scale	Standard Deviation 1
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Sleep Adequacy Score: Week 4	71.0 Units on a scale	Standard Deviation 23
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Short of Breath or Headache score: Week 12	20.0 Units on a scale	Standard Deviation 0
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Sleep Adequacy Score: Week 8	70.0 Units on a scale	Standard Deviation 22.36
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Optimal Hours Slept Score: Week 8	0.5 Units on a scale	Standard Deviation 0.52
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Sleep Adequacy Score: Week 12	76.7 Units on a scale	Standard Deviation 15.28
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Snoring Score: Week 0	43.3 Units on a scale	Standard Deviation 28.26
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Sleep Somnolence Score: Week 0	44.8 Units on a scale	Standard Deviation 20.74
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Quantity Hours Slept Score: Week 8	8.3 Units on a scale	Standard Deviation 3.45
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Sleep Somnolence Score: Week 4	42.9 Units on a scale	Standard Deviation 22.76
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Snoring Score: Week 4	45.7 Units on a scale	Standard Deviation 28.39
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Sleep Somnolence Score: Week 8	45.6 Units on a scale	Standard Deviation 22.91
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Optimal Hours Slept Score: Week 12	0.7 Units on a scale	Standard Deviation 0.58
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Sleep Somnolence Score: Week 12	33.3 Units on a scale	Standard Deviation 13.33
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Snoring Score: Week 8	44.6 Units on a scale	Standard Deviation 24.7
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Sleep Problems Index I Score: Week 0	36.3 Units on a scale	Standard Deviation 13.53
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Optimal Hours Slept Score: Week 0	0.6 Units on a scale	Standard Deviation 0.49
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Sleep Problems Index I Score: Week 4	32.9 Units on a scale	Standard Deviation 16.27
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Snoring Score: Week 12	53.3 Units on a scale	Standard Deviation 23.09
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Sleep Problems Index I Score: Week 8	32.8 Units on a scale	Standard Deviation 9.51
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Short of Breath or Headache score: Week 0	27.9 Units on a scale	Standard Deviation 16.98
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Sleep Problems Index I Score: Week 12	31.1 Units on a scale	Standard Deviation 11.71
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Sleep Disturbance Score: Week 0	41.0 Units on a scale	Standard Deviation 19.08
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Sleep Problems Index II Score: Week 0	38.4 Units on a scale	Standard Deviation 14.19
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Quantity Hours Slept Score: Week 4	8.2 Units on a scale	Standard Deviation 3.88
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Sleep Problems Index II Score: Week 4	35.8 Units on a scale	Standard Deviation 16.81
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Sleep Disturbance Score: Week 4	38.3 Units on a scale	Standard Deviation 18.36
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Sleep Problems Index II Score: Week 8	34.6 Units on a scale	Standard Deviation 10.26
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Short of Breath or Headache score: Week 4	26.7 Units on a scale	Standard Deviation 13.17
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Sleep Problems Index II Score: Week 12	34.1 Units on a scale	Standard Deviation 12.97
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Quantity Hours Slept Score: Week 0	7.3 Units on a scale	Standard Deviation 2.28
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Sleep Problems Index II Score: Week 12	40.3 Units on a scale	Standard Deviation 6.13
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Quantity Hours Slept Score: Week 0	7.6 Units on a scale	Standard Deviation 3.56
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Quantity Hours Slept Score: Week 4	7.3 Units on a scale	Standard Deviation 1.55
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Quantity Hours Slept Score: Week 8	6.9 Units on a scale	Standard Deviation 1.68
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Quantity Hours Slept Score: Week 12	7.3 Units on a scale	Standard Deviation 1.7
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Optimal Hours Slept Score: Week 0	0.4 Units on a scale	Standard Deviation 0.5
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Optimal Hours Slept Score: Week 4	0.6 Units on a scale	Standard Deviation 0.5
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Optimal Hours Slept Score: Week 8	0.5 Units on a scale	Standard Deviation 0.52
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Optimal Hours Slept Score: Week 12	0.4 Units on a scale	Standard Deviation 0.53
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Short of Breath or Headache score: Week 0	28.6 Units on a scale	Standard Deviation 17.47
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Short of Breath or Headache score: Week 4	27.5 Units on a scale	Standard Deviation 14.22
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Short of Breath or Headache score: Week 8	33.3 Units on a scale	Standard Deviation 19.52
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Short of Breath or Headache score: Week 12	22.9 Units on a scale	Standard Deviation 7.56
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Snoring Score: Week 0	37.7 Units on a scale	Standard Deviation 24.86
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Snoring Score: Week 4	39.2 Units on a scale	Standard Deviation 27.96
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Snoring Score: Week 8	38.7 Units on a scale	Standard Deviation 23.26
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Snoring Score: Week 12	34.3 Units on a scale	Standard Deviation 19.02
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Sleep Disturbance Score: Week 0	40.9 Units on a scale	Standard Deviation 19.39
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Sleep Disturbance Score: Week 4	38.6 Units on a scale	Standard Deviation 18.61
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Sleep Disturbance Score: Week 8	41.4 Units on a scale	Standard Deviation 16.77
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Sleep Disturbance Score: Week 12	43.6 Units on a scale	Standard Deviation 13.02
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Sleep Adequacy Score: Week 0	66.1 Units on a scale	Standard Deviation 20.71
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Sleep Adequacy Score: Week 4	67.1 Units on a scale	Standard Deviation 24.22
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Sleep Adequacy Score: Week 8	66.0 Units on a scale	Standard Deviation 19.2
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Sleep Adequacy Score: Week 12	64.3 Units on a scale	Standard Deviation 17.18
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Sleep Somnolence Score: Week 0	45.9 Units on a scale	Standard Deviation 19.3
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Sleep Somnolence Score: Week 4	48.3 Units on a scale	Standard Deviation 19.49
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Sleep Somnolence Score: Week 8	54.2 Units on a scale	Standard Deviation 19.17
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Sleep Somnolence Score: Week 12	50.5 Units on a scale	Standard Deviation 19.57
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Sleep Problems Index I Score: Week 0	37.3 Units on a scale	Standard Deviation 15.29
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Sleep Problems Index I Score: Week 4	36.7 Units on a scale	Standard Deviation 16.33
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Sleep Problems Index I Score: Week 8	38.9 Units on a scale	Standard Deviation 13.07
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Sleep Problems Index I Score: Week 12	39.0 Units on a scale	Standard Deviation 5.35
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Sleep Problems Index II Score: Week 0	38.6 Units on a scale	Standard Deviation 15.55
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Sleep Problems Index II Score: Week 4	38.0 Units on a scale	Standard Deviation 16.06
Crisaborole 2% QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	Sleep Problems Index II Score: Week 8	41.4 Units on a scale	Standard Deviation 13.3

Secondary

Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period

The Medical Outcomes Study (MOS) Sleep Scale is a 12-item measure that is segregated into subscales addressing seven sleep domains (i.e. sleep disturbance, snoring, short of breath or headache, adequacy of sleep, somnolence, sleep problems index I and sleep problems index II) and a single item assessing quantity of sleep. Quantity of sleep scores ranged from 0 to 24 (number of hours slept) and Optimal Sleep score ranged from 0 (no) to 1(yes) based on whether the participant slept for 7-8 hours per night, All other subscales including sleep problems index 1 and 2:were scored on a range of 0 to 100 where, higher scores=greater impairment. Observed scores for each individual sleep domain and quantity of sleep are reported in this outcome measure.

Time frame: Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Sleep Somnolence Score: Baseline	44.9 Units on a scale	Standard Deviation 18.01
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Quantity Hours Slept Score: Baseline	7.4 Units on a scale	Standard Deviation 3.27
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Quantity Hours Slept Score: Week 2	7.6 Units on a scale	Standard Deviation 3.06
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Quantity Hours Slept Score: Week 4	7.6 Units on a scale	Standard Deviation 3.24
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Quantity Hours Slept Score: Week 6	7.9 Units on a scale	Standard Deviation 3.43
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Quantity Hours Slept Score: Week 8	7.8 Units on a scale	Standard Deviation 3.41
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Optimal Hours Slept Score: Baseline	0.4 Units on a scale	Standard Deviation 0.5
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Optimal Hours Slept Score: Week 2	0.5 Units on a scale	Standard Deviation 0.5
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Optimal Hours Slept Score: Week 4	0.5 Units on a scale	Standard Deviation 0.5
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Optimal Hours Slept Score: Week 6	0.5 Units on a scale	Standard Deviation 0.5
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Optimal Hours Slept Score: Week 8	0.5 Units on a scale	Standard Deviation 0.5
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Short of Breath or Headache score: Baseline	27.8 Units on a scale	Standard Deviation 15.18
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Short of Breath or Headache score: Week 2	27.6 Units on a scale	Standard Deviation 13.98
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Short of Breath or Headache score: Week 4	27.0 Units on a scale	Standard Deviation 14.56
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Short of Breath or Headache score: Week 6	27.0 Units on a scale	Standard Deviation 13.95
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Short of Breath or Headache score: Week 8	26.4 Units on a scale	Standard Deviation 14
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Snoring Score: Baseline	43.3 Units on a scale	Standard Deviation 27.34
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Snoring Score: Week 2	41.1 Units on a scale	Standard Deviation 26.73
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Snoring Score: Week 4	41.0 Units on a scale	Standard Deviation 26.02
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Snoring Score: Week 6	40.9 Units on a scale	Standard Deviation 26.44
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Snoring Score: Week 8	40.5 Units on a scale	Standard Deviation 26.09
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Sleep Disturbance Score: Baseline	45.0 Units on a scale	Standard Deviation 21.27
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Sleep Disturbance Score: Week 2	40.0 Units on a scale	Standard Deviation 20.21
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Sleep Disturbance Score: Week 4	40.3 Units on a scale	Standard Deviation 21.2
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Sleep Disturbance Score: Week 6	38.5 Units on a scale	Standard Deviation 20.25
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Sleep Disturbance Score: Week 8	38.6 Units on a scale	Standard Deviation 20.93
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Sleep Adequacy Score: Baseline	63.0 Units on a scale	Standard Deviation 19.99
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Sleep Adequacy Score: Week 2	66.1 Units on a scale	Standard Deviation 20.64
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Sleep Adequacy Score: Week 4	65.5 Units on a scale	Standard Deviation 20.67
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Sleep Adequacy Score: Week 6	66.8 Units on a scale	Standard Deviation 20.12
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Sleep Adequacy Score: Week 8	67.3 Units on a scale	Standard Deviation 20.33
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Sleep Somnolence Score: Week 2	42.5 Units on a scale	Standard Deviation 17.19
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Sleep Somnolence Score: Week 4	42.5 Units on a scale	Standard Deviation 18.12
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Sleep Somnolence Score: Week 6	42.5 Units on a scale	Standard Deviation 17.93
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Sleep Somnolence Score: Week 8	42.5 Units on a scale	Standard Deviation 19.08
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Sleep Problems Index I Score: Baseline	38.3 Units on a scale	Standard Deviation 14.74
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Sleep Problems Index I Score: Week 2	35.3 Units on a scale	Standard Deviation 13.83
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Sleep Problems Index I Score: Week 4	36.1 Units on a scale	Standard Deviation 14.97
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Sleep Problems Index I Score: Week 6	34.9 Units on a scale	Standard Deviation 14.08
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Sleep Problems Index I Score: Week 8	34.7 Units on a scale	Standard Deviation 14.03
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Sleep Problems Index II Score: Baseline	41.5 Units on a scale	Standard Deviation 15.39
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Sleep Problems Index II Score: Week 2	37.7 Units on a scale	Standard Deviation 14.67
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Sleep Problems Index II Score: Week 4	38.1 Units on a scale	Standard Deviation 15.73
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Sleep Problems Index II Score: Week 6	36.9 Units on a scale	Standard Deviation 14.82
Vehicle QD	Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	Sleep Problems Index II Score: Week 8	36.6 Units on a scale	Standard Deviation 15.13

Secondary

Night Time Itch Score for Participants >=12 Years of Age: DB Period

The severity and frequency of itch (pruritus) during the night due to AD was assessed using a horizontal scale. Participants 12 years of age or older were asked to assess their worst itching and frequency of itching due to AD during their most recent night's sleep on a scale of 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch. Scale range of Frequency of night time itch was 0 to 10, where 0=no and 10=the most frequency imaginable. Higher score indicated higher frequency.

Time frame: Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Week 24	1.5 Units on a scale	Standard Deviation 1.71
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Week 40	1.4 Units on a scale	Standard Deviation 1.46
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Week 16	1.7 Units on a scale	Standard Deviation 1.85
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Week 20	1.6 Units on a scale	Standard Deviation 1.82
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Week 44	1.6 Units on a scale	Standard Deviation 1.69
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Week 8	1.6 Units on a scale	Standard Deviation 1.61
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Week 16	1.6 Units on a scale	Standard Deviation 1.87
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Week 48	1.6 Units on a scale	Standard Deviation 1.76
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Baseline	1.9 Units on a scale	Standard Deviation 1.71
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Week 12	1.5 Units on a scale	Standard Deviation 1.76
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Week 52	1.4 Units on a scale	Standard Deviation 1.69
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Week 20	1.6 Units on a scale	Standard Deviation 1.86
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Week 8	1.6 Units on a scale	Standard Deviation 1.71
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Baseline	1.9 Units on a scale	Standard Deviation 1.66
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Week 4	2.0 Units on a scale	Standard Deviation 1.83
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Week 4	1.9 Units on a scale	Standard Deviation 1.89
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Week 40	1.4 Units on a scale	Standard Deviation 1.53
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Week 24	1.6 Units on a scale	Standard Deviation 1.71
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Week 48	1.6 Units on a scale	Standard Deviation 1.78
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Week 36	1.3 Units on a scale	Standard Deviation 1.57
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Week 28	1.6 Units on a scale	Standard Deviation 1.69
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Week 12	1.6 Units on a scale	Standard Deviation 1.74
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Week 32	1.3 Units on a scale	Standard Deviation 1.56
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Week 32	1.4 Units on a scale	Standard Deviation 1.57
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Week 52	1.3 Units on a scale	Standard Deviation 1.7
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Week 28	1.5 Units on a scale	Standard Deviation 1.71
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Week 36	1.4 Units on a scale	Standard Deviation 1.56
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Week 44	1.5 Units on a scale	Standard Deviation 1.71
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Week 40	1.2 Units on a scale	Standard Deviation 1.91
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Baseline	1.8 Units on a scale	Standard Deviation 1.79
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Week 4	1.2 Units on a scale	Standard Deviation 1.49
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Week 8	1.1 Units on a scale	Standard Deviation 1.59
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Week 12	1.1 Units on a scale	Standard Deviation 1.64
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Week 16	1.2 Units on a scale	Standard Deviation 1.7
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Week 20	1.3 Units on a scale	Standard Deviation 1.86
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Week 24	1.2 Units on a scale	Standard Deviation 1.79
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Week 28	1.2 Units on a scale	Standard Deviation 1.73
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Week 32	1.1 Units on a scale	Standard Deviation 1.74
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Week 36	1.1 Units on a scale	Standard Deviation 1.85
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Week 40	1.2 Units on a scale	Standard Deviation 1.95
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Week 44	1.2 Units on a scale	Standard Deviation 1.98
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Week 48	1.1 Units on a scale	Standard Deviation 1.93
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Week 52	1.2 Units on a scale	Standard Deviation 1.96
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Baseline	1.8 Units on a scale	Standard Deviation 1.79
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Week 4	1.1 Units on a scale	Standard Deviation 1.43
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Week 8	1.1 Units on a scale	Standard Deviation 1.55
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Week 12	1.1 Units on a scale	Standard Deviation 1.64
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Week 16	1.2 Units on a scale	Standard Deviation 1.64
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Week 20	1.3 Units on a scale	Standard Deviation 1.82
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Week 24	1.2 Units on a scale	Standard Deviation 1.77
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Week 28	1.2 Units on a scale	Standard Deviation 1.7
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Week 32	1.0 Units on a scale	Standard Deviation 1.72
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Week 36	1.1 Units on a scale	Standard Deviation 1.82
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Week 44	1.2 Units on a scale	Standard Deviation 1.95
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Week 48	1.1 Units on a scale	Standard Deviation 1.87
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Week 52	1.2 Units on a scale	Standard Deviation 1.98
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Week 4	2.2 Units on a scale	Standard Deviation 1.87
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Week 20	2.0 Units on a scale	Standard Deviation 1.54
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Week 36	1.8 Units on a scale	Standard Deviation 1.94
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Week 44	1.5 Units on a scale	Standard Deviation 1.63
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Week 24	1.7 Units on a scale	Standard Deviation 1.69
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Week 32	2.2 Units on a scale	Standard Deviation 2.02
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Week 8	2.0 Units on a scale	Standard Deviation 2.08
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Week 28	1.7 Units on a scale	Standard Deviation 1.81
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Week 28	1.9 Units on a scale	Standard Deviation 1.84
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Week 52	1.3 Units on a scale	Standard Deviation 1.21
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Week 32	2.1 Units on a scale	Standard Deviation 1.84
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Week 24	1.7 Units on a scale	Standard Deviation 1.72
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Week 48	1.5 Units on a scale	Standard Deviation 1.66
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Week 36	1.8 Units on a scale	Standard Deviation 1.87
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Week 20	2.2 Units on a scale	Standard Deviation 1.57
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Week 4	2.2 Units on a scale	Standard Deviation 1.83
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Week 52	1.3 Units on a scale	Standard Deviation 1.12
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Week 16	1.9 Units on a scale	Standard Deviation 1.77
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Week 8	2.0 Units on a scale	Standard Deviation 2.1
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Week 48	1.7 Units on a scale	Standard Deviation 1.72
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Week 40	2.1 Units on a scale	Standard Deviation 1.81
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Week 12	2.1 Units on a scale	Standard Deviation 2.25
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Week 44	1.6 Units on a scale	Standard Deviation 1.52
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Week 12	2.2 Units on a scale	Standard Deviation 2.18
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Frequency of night time itch: Week 16	1.8 Units on a scale	Standard Deviation 1.97
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: DB Period	Severity of night time itch: Week 40	2.2 Units on a scale	Standard Deviation 1.68

Secondary

Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period

Time frame: Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Frequency of night time itch: Baseline	1.9 Units on a scale	Standard Deviation 1.66
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Severity of night time itch: Week 16	1.7 Units on a scale	Standard Deviation 1.3
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Frequency of night time itch: Week 4	1.9 Units on a scale	Standard Deviation 1.93
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Severity of night time itch: Week 32	1.5 Units on a scale	Standard Deviation 1.27
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Frequency of night time itch: Week 8	1.8 Units on a scale	Standard Deviation 1.8
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Severity of night time itch: Week 4	2.0 Units on a scale	Standard Deviation 1.87
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Frequency of night time itch: Week 12	1.4 Units on a scale	Standard Deviation 1.31
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Severity of night time itch: Week 36	1.5 Units on a scale	Standard Deviation 1.24
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Frequency of night time itch: Week 16	1.6 Units on a scale	Standard Deviation 1.29
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Severity of night time itch: Week 20	1.6 Units on a scale	Standard Deviation 1.26
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Frequency of night time itch: Week 20	1.5 Units on a scale	Standard Deviation 1.16
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Severity of night time itch: Week 40	1.6 Units on a scale	Standard Deviation 1.24
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Frequency of night time itch: Week 24	1.4 Units on a scale	Standard Deviation 1.21
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Severity of night time itch: Week 12	1.5 Units on a scale	Standard Deviation 1.27
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Frequency of night time itch: Week 28	1.3 Units on a scale	Standard Deviation 1.19
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Severity of night time itch: Week 44	1.9 Units on a scale	Standard Deviation 1.2
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Frequency of night time itch: Week 32	1.3 Units on a scale	Standard Deviation 1.24
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Severity of night time itch: Week 24	1.6 Units on a scale	Standard Deviation 1.23
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Frequency of night time itch: Week 36	1.3 Units on a scale	Standard Deviation 1.22
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Severity of night time itch: Week 48	1.5 Units on a scale	Standard Deviation 1.27
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Frequency of night time itch: Week 40	1.6 Units on a scale	Standard Deviation 1.37
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Severity of night time itch: Week 8	1.8 Units on a scale	Standard Deviation 1.68
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Frequency of night time itch: Week 44	1.8 Units on a scale	Standard Deviation 1.22
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Severity of night time itch: Week 52	1.6 Units on a scale	Standard Deviation 1.35
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Frequency of night time itch: Week 48	1.5 Units on a scale	Standard Deviation 1.32
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Severity of night time itch: Week 28	1.6 Units on a scale	Standard Deviation 1.21
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Frequency of night time itch: Week 52	1.3 Units on a scale	Standard Deviation 1.38
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Severity of night time itch: Baseline	1.9 Units on a scale	Standard Deviation 1.71
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Frequency of night time itch: Week 52	1.2 Units on a scale	Standard Deviation 2.3
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Severity of night time itch: Baseline	1.8 Units on a scale	Standard Deviation 1.79
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Severity of night time itch: Week 4	1.2 Units on a scale	Standard Deviation 1.49
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Severity of night time itch: Week 8	1.2 Units on a scale	Standard Deviation 1.64
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Severity of night time itch: Week 12	1.1 Units on a scale	Standard Deviation 1.72
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Severity of night time itch: Week 16	1.2 Units on a scale	Standard Deviation 1.84
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Severity of night time itch: Week 20	1.4 Units on a scale	Standard Deviation 1.99
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Severity of night time itch: Week 24	1.2 Units on a scale	Standard Deviation 1.92
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Severity of night time itch: Week 28	1.2 Units on a scale	Standard Deviation 1.86
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Severity of night time itch: Week 32	1.2 Units on a scale	Standard Deviation 1.99
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Severity of night time itch: Week 36	1.1 Units on a scale	Standard Deviation 2.02
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Severity of night time itch: Week 40	1.1 Units on a scale	Standard Deviation 2.08
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Severity of night time itch: Week 44	1.1 Units on a scale	Standard Deviation 2.26
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Severity of night time itch: Week 48	1.2 Units on a scale	Standard Deviation 2.24
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Severity of night time itch: Week 52	1.2 Units on a scale	Standard Deviation 2.29
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Frequency of night time itch: Baseline	1.8 Units on a scale	Standard Deviation 1.79
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Frequency of night time itch: Week 4	1.1 Units on a scale	Standard Deviation 1.43
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Frequency of night time itch: Week 8	1.1 Units on a scale	Standard Deviation 1.6
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Frequency of night time itch: Week 12	1.1 Units on a scale	Standard Deviation 1.73
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Frequency of night time itch: Week 16	1.2 Units on a scale	Standard Deviation 1.79
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Frequency of night time itch: Week 20	1.3 Units on a scale	Standard Deviation 1.92
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Frequency of night time itch: Week 24	1.2 Units on a scale	Standard Deviation 1.91
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Frequency of night time itch: Week 28	1.2 Units on a scale	Standard Deviation 1.89
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Frequency of night time itch: Week 32	1.1 Units on a scale	Standard Deviation 2.04
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Frequency of night time itch: Week 36	1.1 Units on a scale	Standard Deviation 2.05
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Frequency of night time itch: Week 40	1.1 Units on a scale	Standard Deviation 2.06
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Frequency of night time itch: Week 44	1.2 Units on a scale	Standard Deviation 2.25
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	Frequency of night time itch: Week 48	1.3 Units on a scale	Standard Deviation 2.18

Secondary

Night Time Itch Score for Participants >=12 Years of Age: First Flare Period

Time frame: Weeks 0, 4, 8 and 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Period	Severity of night time itch: Week 8	2.2 Units on a scale	Standard Deviation 1.73
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Period	Severity of night time itch: Week 12	1.8 Units on a scale	Standard Deviation 1.32
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Period	Frequency of night time itch: Week 0	2.0 Units on a scale	Standard Deviation 1.13
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Period	Frequency of night time itch: Week 4	2.0 Units on a scale	Standard Deviation 2.13
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Period	Frequency of night time itch: Week 8	2.1 Units on a scale	Standard Deviation 1.96
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Period	Frequency of night time itch: Week 12	1.3 Units on a scale	Standard Deviation 1.26
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Period	Severity of night time itch: Week 0	2.0 Units on a scale	Standard Deviation 1.12
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Period	Severity of night time itch: Week 4	2.0 Units on a scale	Standard Deviation 1.95
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Period	Severity of night time itch: Week 4	2.2 Units on a scale	Standard Deviation 2.18
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Period	Severity of night time itch: Week 8	2.8 Units on a scale	Standard Deviation 2.6
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Period	Frequency of night time itch: Week 8	2.6 Units on a scale	Standard Deviation 2.54
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Period	Severity of night time itch: Week 12	2.8 Units on a scale	Standard Deviation 2.03
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Period	Severity of night time itch: Week 0	2.0 Units on a scale	Standard Deviation 2.32
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Period	Frequency of night time itch: Week 0	2.0 Units on a scale	Standard Deviation 2.32
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Period	Frequency of night time itch: Week 12	2.7 Units on a scale	Standard Deviation 2.09
Crisaborole 2% QD	Night Time Itch Score for Participants >=12 Years of Age: First Flare Period	Frequency of night time itch: Week 4	2.1 Units on a scale	Standard Deviation 2.11

Secondary

Night Time Itch Score for Participants >=12 Years of Age: OL Run-in Period

Time frame: Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: OL Run-in Period	Severity of night time itch: Baseline	4.6 Units on a scale	Standard Deviation 3.02
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: OL Run-in Period	Severity of night time itch: Week 2	2.9 Units on a scale	Standard Deviation 2.21
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: OL Run-in Period	Severity of night time itch: Week 4	2.7 Units on a scale	Standard Deviation 2.25
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: OL Run-in Period	Severity of night time itch: Week 6	2.5 Units on a scale	Standard Deviation 2.16
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: OL Run-in Period	Severity of night time itch: Week 8	2.5 Units on a scale	Standard Deviation 2.19
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: OL Run-in Period	Frequency of night time itch: Baseline	4.4 Units on a scale	Standard Deviation 2.8
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: OL Run-in Period	Frequency of night time itch: Week 2	2.8 Units on a scale	Standard Deviation 2.2
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: OL Run-in Period	Frequency of night time itch: Week 4	2.7 Units on a scale	Standard Deviation 2.23
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: OL Run-in Period	Frequency of night time itch: Week 6	2.4 Units on a scale	Standard Deviation 2.15
Vehicle QD	Night Time Itch Score for Participants >=12 Years of Age: OL Run-in Period	Frequency of night time itch: Week 8	2.4 Units on a scale	Standard Deviation 2.16

Secondary

Number of Flare-Free Days During the DB Period

Flare - free days was the sum of the duration of flare-free maintenance during the DB maintenance period for each participant.

Time frame: Up to maximum of 52 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Vehicle QD	Number of Flare-Free Days During the DB Period	199.42 Days	Standard Error 11.824
Crisaborole 2% QD	Number of Flare-Free Days During the DB Period	234.01 Days	Standard Error 12.323

p-value: 0.034695% CI: [2.53, 66.64]ANCOVA

Secondary

Number of Flares During the DB Period

Flare was defined as an ISGA score of \>=2. The ISGA is a 5-point scale (range 0 to 4), reflecting a global assessment of AD severity based on erythema, induration/papulation, and oozing/crusting. ISGA score of 2: mild (faint pink erythema with mild induration/papulation and no oozing/crusting) 3: moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting) and 4: severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting).

Time frame: Up to maximum of 52 weeks

Arm	Measure	Value (MEDIAN)
Vehicle QD	Number of Flares During the DB Period	1.00 Flares
Crisaborole 2% QD	Number of Flares During the DB Period	1.00 Flares

p-value: 0.004295% CI: [-1, 0]Wilcoxon (Mann-Whitney)

Secondary

Patient/Observer Global Impression of Change Score: DB Period

PGIC/OGIC is a single item instrument using 7-point rating scale and was used to determine global improvement at a given point in time since the start of study drug. The scores ranged from 1=very much improved to 7=very much worse. The PGIC was completed by all participants \>=12 years of age and OGIC was completed by the observer for participants 3 months-\<12 years of age.

Time frame: Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Week 24	1.7 Units on a scale	Standard Deviation 0.9
Vehicle QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Week 40	1.8 Units on a scale	Standard Deviation 0.91
Vehicle QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Week 16	2.1 Units on a scale	Standard Deviation 1
Vehicle QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Week 20	1.9 Units on a scale	Standard Deviation 0.72
Vehicle QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Week 44	1.8 Units on a scale	Standard Deviation 0.79
Vehicle QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Week 8	2.0 Units on a scale	Standard Deviation 0.74
Vehicle QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Week 16	1.8 Units on a scale	Standard Deviation 0.97
Vehicle QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Week 48	1.5 Units on a scale	Standard Deviation 0.63
Vehicle QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Baseline	1.8 Units on a scale	Standard Deviation 0.68
Vehicle QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Week 12	1.6 Units on a scale	Standard Deviation 0.68
Vehicle QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Week 52	1.8 Units on a scale	Standard Deviation 0.76
Vehicle QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Week 20	2.3 Units on a scale	Standard Deviation 1.1
Vehicle QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Week 8	1.5 Units on a scale	Standard Deviation 0.57
Vehicle QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Baseline	1.5 Units on a scale	Standard Deviation 0.6
Vehicle QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Week 4	1.9 Units on a scale	Standard Deviation 0.84
Vehicle QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Week 4	1.7 Units on a scale	Standard Deviation 0.95
Vehicle QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Week 40	1.9 Units on a scale	Standard Deviation 0.85
Vehicle QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Week 24	1.7 Units on a scale	Standard Deviation 0.7
Vehicle QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Week 48	1.6 Units on a scale	Standard Deviation 0.67
Vehicle QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Week 36	1.6 Units on a scale	Standard Deviation 0.51
Vehicle QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Week 28	2.2 Units on a scale	Standard Deviation 1.06
Vehicle QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Week 12	2.0 Units on a scale	Standard Deviation 0.76
Vehicle QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Week 32	1.9 Units on a scale	Standard Deviation 1.24
Vehicle QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Week 32	1.7 Units on a scale	Standard Deviation 0.72
Vehicle QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Week 52	1.6 Units on a scale	Standard Deviation 0.78
Vehicle QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Week 28	1.6 Units on a scale	Standard Deviation 0.73
Vehicle QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Week 36	1.9 Units on a scale	Standard Deviation 0.93
Vehicle QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Week 44	1.6 Units on a scale	Standard Deviation 0.51
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Week 40	1.7 Units on a scale	Standard Deviation 0.87
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Baseline	1.8 Units on a scale	Standard Deviation 0.75
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Week 4	1.8 Units on a scale	Standard Deviation 0.76
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Week 8	1.9 Units on a scale	Standard Deviation 0.88
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Week 12	1.9 Units on a scale	Standard Deviation 1
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Week 16	1.8 Units on a scale	Standard Deviation 0.79
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Week 20	1.6 Units on a scale	Standard Deviation 0.8
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Week 24	1.8 Units on a scale	Standard Deviation 1.1
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Week 28	1.6 Units on a scale	Standard Deviation 0.8
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Week 32	1.8 Units on a scale	Standard Deviation 1.26
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Week 36	1.8 Units on a scale	Standard Deviation 0.66
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Week 40	1.8 Units on a scale	Standard Deviation 1.1
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Week 44	1.8 Units on a scale	Standard Deviation 0.75
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Week 48	1.9 Units on a scale	Standard Deviation 1.34
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Week 52	1.6 Units on a scale	Standard Deviation 1.01
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Baseline	1.6 Units on a scale	Standard Deviation 0.61
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Week 4	2.0 Units on a scale	Standard Deviation 1.23
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Week 8	1.8 Units on a scale	Standard Deviation 0.98
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Week 12	1.5 Units on a scale	Standard Deviation 0.65
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Week 16	1.5 Units on a scale	Standard Deviation 0.58
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Week 20	1.4 Units on a scale	Standard Deviation 0.62
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Week 24	1.7 Units on a scale	Standard Deviation 0.77
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Week 28	1.4 Units on a scale	Standard Deviation 0.68
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Week 32	1.8 Units on a scale	Standard Deviation 1.09
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Week 36	1.5 Units on a scale	Standard Deviation 0.64
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Week 44	1.8 Units on a scale	Standard Deviation 1.14
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Week 48	1.6 Units on a scale	Standard Deviation 0.89
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Week 52	1.5 Units on a scale	Standard Deviation 0.6
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Week 4	3.7 Units on a scale	Standard Deviation 1.53
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Week 20	2.4 Units on a scale	Standard Deviation 0.8
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Week 36	2.4 Units on a scale	Standard Deviation 1.13
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Week 44	2.4 Units on a scale	Standard Deviation 0.73
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Week 24	2.3 Units on a scale	Standard Deviation 1.21
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Week 32	2.4 Units on a scale	Standard Deviation 1.19
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Week 8	2.9 Units on a scale	Standard Deviation 1.38
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Week 28	2.1 Units on a scale	Standard Deviation 1.03
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Week 28	3.4 Units on a scale	Standard Deviation 1.34
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Week 52	2.3 Units on a scale	Standard Deviation 0.75
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Week 32	2.7 Units on a scale	Standard Deviation 1.26
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Week 24	2.9 Units on a scale	Standard Deviation 1.23
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Week 48	2.6 Units on a scale	Standard Deviation 1.41
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Week 36	2.7 Units on a scale	Standard Deviation 1.28
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Week 20	2.4 Units on a scale	Standard Deviation 1.03
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Week 4	3.4 Units on a scale	Standard Deviation 1.62
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Week 52	1.8 Units on a scale	Standard Deviation 0.86
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Week 16	3.0 Units on a scale	Standard Deviation 1.32
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Week 8	2.8 Units on a scale	Standard Deviation 1.37
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Week 48	2.8 Units on a scale	Standard Deviation 1.42
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Week 40	2.8 Units on a scale	Standard Deviation 1.56
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Week 12	2.8 Units on a scale	Standard Deviation 1.15
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Week 44	3.2 Units on a scale	Standard Deviation 1.33
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Week 12	3.1 Units on a scale	Standard Deviation 1.41
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	3 months to <12 years of age: Week 16	2.6 Units on a scale	Standard Deviation 1.31
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: DB Period	>= 12 years of age: Week 40	3.3 Units on a scale	Standard Deviation 1.58

Secondary

Patient/Observer Global Impression of Change Score: First Flare Free Period

Time frame: Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	3 months to <12 years of age: Week 48	1.5 Units on a scale	Standard Deviation 0.55
Vehicle QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	>= 12 years of age: Baseline	1.8 Units on a scale	Standard Deviation 0.68
Vehicle QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	>= 12 years of age: Week 4	2.0 Units on a scale	Standard Deviation 0.83
Vehicle QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	>= 12 years of age: Week 8	2.1 Units on a scale	Standard Deviation 0.73
Vehicle QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	>= 12 years of age: Week 12	2.0 Units on a scale	Standard Deviation 0.86
Vehicle QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	>= 12 years of age: Week 16	2.3 Units on a scale	Standard Deviation 1.29
Vehicle QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	>= 12 years of age: Week 20	1.9 Units on a scale	Standard Deviation 0.64
Vehicle QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	>= 12 years of age: Week 24	1.8 Units on a scale	Standard Deviation 0.83
Vehicle QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	>= 12 years of age: Week 28	1.9 Units on a scale	Standard Deviation 0.69
Vehicle QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	>= 12 years of age: Week 32	1.7 Units on a scale	Standard Deviation 0.6
Vehicle QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	>= 12 years of age: Week 36	2.0 Units on a scale	Standard Deviation 1.26
Vehicle QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	>= 12 years of age: Week 40	1.7 Units on a scale	Standard Deviation 0.85
Vehicle QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	>= 12 years of age: Week 44	2.1 Units on a scale	Standard Deviation 1.07
Vehicle QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	>= 12 years of age: Week 48	1.5 Units on a scale	Standard Deviation 0.62
Vehicle QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	>= 12 years of age: Week 52	1.7 Units on a scale	Standard Deviation 0.88
Vehicle QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	3 months to <12 years of age: Baseline	1.5 Units on a scale	Standard Deviation 0.6
Vehicle QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	3 months to <12 years of age: Week 4	1.8 Units on a scale	Standard Deviation 0.97
Vehicle QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	3 months to <12 years of age: Week 8	1.7 Units on a scale	Standard Deviation 0.62
Vehicle QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	3 months to <12 years of age: Week 12	1.7 Units on a scale	Standard Deviation 0.8
Vehicle QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	3 months to <12 years of age: Week 16	1.6 Units on a scale	Standard Deviation 0.97
Vehicle QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	3 months to <12 years of age: Week 20	1.7 Units on a scale	Standard Deviation 0.58
Vehicle QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	3 months to <12 years of age: Week 24	1.6 Units on a scale	Standard Deviation 0.53
Vehicle QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	3 months to <12 years of age: Week 28	1.0 Units on a scale	Standard Deviation 0
Vehicle QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	3 months to <12 years of age: Week 32	1.6 Units on a scale	Standard Deviation 0.52
Vehicle QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	3 months to <12 years of age: Week 36	1.0 Units on a scale	—
Vehicle QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	3 months to <12 years of age: Week 40	1.7 Units on a scale	Standard Deviation 0.76
Vehicle QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	3 months to <12 years of age: Week 44	1.0 Units on a scale	—
Vehicle QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	3 months to <12 years of age: Week 52	1.1 Units on a scale	Standard Deviation 0.38
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	>= 12 years of age: Week 52	1.4 Units on a scale	Standard Deviation 0.5
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	3 months to <12 years of age: Week 40	1.3 Units on a scale	Standard Deviation 0.46
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	>= 12 years of age: Baseline	1.8 Units on a scale	Standard Deviation 0.75
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	3 months to <12 years of age: Baseline	1.6 Units on a scale	Standard Deviation 0.61
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	>= 12 years of age: Week 4	1.8 Units on a scale	Standard Deviation 0.76
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	3 months to <12 years of age: Week 28	1.3 Units on a scale	Standard Deviation 0.71
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	>= 12 years of age: Week 8	1.9 Units on a scale	Standard Deviation 0.9
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	3 months to <12 years of age: Week 4	2.0 Units on a scale	Standard Deviation 1.23
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	>= 12 years of age: Week 12	2.0 Units on a scale	Standard Deviation 1.04
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	3 months to <12 years of age: Week 52	1.3 Units on a scale	Standard Deviation 0.49
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	>= 12 years of age: Week 16	1.8 Units on a scale	Standard Deviation 0.76
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	3 months to <12 years of age: Week 8	1.8 Units on a scale	Standard Deviation 1
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	>= 12 years of age: Week 20	1.5 Units on a scale	Standard Deviation 0.52
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	3 months to <12 years of age: Week 32	1.7 Units on a scale	Standard Deviation 0.9
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	>= 12 years of age: Week 24	1.6 Units on a scale	Standard Deviation 0.8
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	3 months to <12 years of age: Week 12	1.6 Units on a scale	Standard Deviation 0.62
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	>= 12 years of age: Week 28	1.4 Units on a scale	Standard Deviation 0.53
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	3 months to <12 years of age: Week 44	1.4 Units on a scale	Standard Deviation 0.55
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	>= 12 years of age: Week 32	1.6 Units on a scale	Standard Deviation 0.97
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	3 months to <12 years of age: Week 16	1.6 Units on a scale	Standard Deviation 0.63
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	>= 12 years of age: Week 36	1.4 Units on a scale	Standard Deviation 0.53
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	3 months to <12 years of age: Week 36	1.5 Units on a scale	Standard Deviation 0.53
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	>= 12 years of age: Week 40	1.5 Units on a scale	Standard Deviation 0.58
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	3 months to <12 years of age: Week 20	1.4 Units on a scale	Standard Deviation 0.73
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	>= 12 years of age: Week 44	1.6 Units on a scale	Standard Deviation 0.73
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	3 months to <12 years of age: Week 48	1.3 Units on a scale	Standard Deviation 0.49
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	>= 12 years of age: Week 48	1.6 Units on a scale	Standard Deviation 1.1
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: First Flare Free Period	3 months to <12 years of age: Week 24	1.6 Units on a scale	Standard Deviation 0.84

Secondary

Patient/Observer Global Impression of Change Score: First Flare Period

Time frame: Weeks 0, 4, 8 and 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Patient/Observer Global Impression of Change Score: First Flare Period	>= 12 years of age: Week 0	3.8 Units on a scale	Standard Deviation 1.56
Vehicle QD	Patient/Observer Global Impression of Change Score: First Flare Period	>= 12 years of age: Week 4	2.7 Units on a scale	Standard Deviation 1.42
Vehicle QD	Patient/Observer Global Impression of Change Score: First Flare Period	>= 12 years of age: Week 8	2.4 Units on a scale	Standard Deviation 0.51
Vehicle QD	Patient/Observer Global Impression of Change Score: First Flare Period	>= 12 years of age: Week 12	2.7 Units on a scale	Standard Deviation 0.58
Vehicle QD	Patient/Observer Global Impression of Change Score: First Flare Period	3 months to <12 years of age: Week 0	3.8 Units on a scale	Standard Deviation 1.84
Vehicle QD	Patient/Observer Global Impression of Change Score: First Flare Period	3 months to <12 years of age: Week 4	2.4 Units on a scale	Standard Deviation 0.95
Vehicle QD	Patient/Observer Global Impression of Change Score: First Flare Period	3 months to <12 years of age: Week 8	2.3 Units on a scale	Standard Deviation 0.97
Vehicle QD	Patient/Observer Global Impression of Change Score: First Flare Period	3 months to <12 years of age: Week 12	2.4 Units on a scale	Standard Deviation 0.55
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: First Flare Period	3 months to <12 years of age: Week 12	4.5 Units on a scale	Standard Deviation 0.71
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: First Flare Period	>= 12 years of age: Week 0	3.1 Units on a scale	Standard Deviation 1.51
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: First Flare Period	3 months to <12 years of age: Week 0	3.3 Units on a scale	Standard Deviation 1.53
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: First Flare Period	>= 12 years of age: Week 4	2.9 Units on a scale	Standard Deviation 1.3
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: First Flare Period	3 months to <12 years of age: Week 8	3.0 Units on a scale	Standard Deviation 1.41
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: First Flare Period	>= 12 years of age: Week 8	3.2 Units on a scale	Standard Deviation 1.26
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: First Flare Period	3 months to <12 years of age: Week 4	2.6 Units on a scale	Standard Deviation 0.97
Crisaborole 2% QD	Patient/Observer Global Impression of Change Score: First Flare Period	>= 12 years of age: Week 12	3.7 Units on a scale	Standard Deviation 1.11

Secondary

Patient/Observer Global Impression of Change Score: OL Run-in Period

Patient/Observer Global Impression of Change (PGIC/OGIC) is a single item instrument using 7-point rating scale and was used to determine global improvement at a given point in time since the start of study drug. The scores ranged from 1=very much improved to 7=very much worse. The PGIC was completed by all participants \>=12 years of age and OGIC was completed by the observer for participants 3 months-\<12 years of age.

Time frame: Weeks 2, 4, 6 and 8

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Patient/Observer Global Impression of Change Score: OL Run-in Period	>= 12 years of age: Week 2	2.8 Units on a scale	Standard Deviation 1.17
Vehicle QD	Patient/Observer Global Impression of Change Score: OL Run-in Period	>= 12 years of age: Week 4	2.7 Units on a scale	Standard Deviation 1.32
Vehicle QD	Patient/Observer Global Impression of Change Score: OL Run-in Period	>= 12 years of age: Week 6	2.6 Units on a scale	Standard Deviation 1.36
Vehicle QD	Patient/Observer Global Impression of Change Score: OL Run-in Period	>= 12 years of age: Week 8	2.6 Units on a scale	Standard Deviation 1.46
Vehicle QD	Patient/Observer Global Impression of Change Score: OL Run-in Period	3 months to <12 years: Week 2	2.6 Units on a scale	Standard Deviation 1.21
Vehicle QD	Patient/Observer Global Impression of Change Score: OL Run-in Period	3 months to <12 years: Week 4	2.6 Units on a scale	Standard Deviation 1.36
Vehicle QD	Patient/Observer Global Impression of Change Score: OL Run-in Period	3 months to <12 years: Week 6	2.5 Units on a scale	Standard Deviation 1.5
Vehicle QD	Patient/Observer Global Impression of Change Score: OL Run-in Period	3 months to <12 years: Week 8	2.5 Units on a scale	Standard Deviation 1.57

Secondary

Patient/Observer Global Impression of Severity Score: DB Period

PGIS/OGIS is a single item participant or observer rated measure of the participant's AD condition severity at a given point in time using a 7-point rating scale, which ranges from 1 to 7, where 1=not present to 7=extremely severe. The PGIS was completed by all participants \>=12 years of age and OGIS was completed by the observer for participants 3 months-\<12 years of age.

Time frame: Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Week 24	2.4 Units on a scale	Standard Deviation 1.04
Vehicle QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Week 40	2.6 Units on a scale	Standard Deviation 1.12
Vehicle QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Week 16	2.7 Units on a scale	Standard Deviation 1.15
Vehicle QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Week 20	2.4 Units on a scale	Standard Deviation 1.03
Vehicle QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Week 44	2.6 Units on a scale	Standard Deviation 1.18
Vehicle QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Week 8	2.6 Units on a scale	Standard Deviation 0.93
Vehicle QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Week 16	2.4 Units on a scale	Standard Deviation 1.14
Vehicle QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Week 48	2.7 Units on a scale	Standard Deviation 1.27
Vehicle QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Baseline	2.6 Units on a scale	Standard Deviation 1.03
Vehicle QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Week 12	2.3 Units on a scale	Standard Deviation 0.99
Vehicle QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Week 52	2.4 Units on a scale	Standard Deviation 1.19
Vehicle QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Week 20	2.7 Units on a scale	Standard Deviation 0.98
Vehicle QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Week 8	2.3 Units on a scale	Standard Deviation 1.13
Vehicle QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Baseline	2.6 Units on a scale	Standard Deviation 0.99
Vehicle QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Week 4	2.7 Units on a scale	Standard Deviation 1.14
Vehicle QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Week 4	2.6 Units on a scale	Standard Deviation 1.14
Vehicle QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Week 40	2.2 Units on a scale	Standard Deviation 0.74
Vehicle QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Week 24	2.6 Units on a scale	Standard Deviation 1.06
Vehicle QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Week 48	2.2 Units on a scale	Standard Deviation 0.8
Vehicle QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Week 36	2.4 Units on a scale	Standard Deviation 1.18
Vehicle QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Week 28	2.7 Units on a scale	Standard Deviation 1.04
Vehicle QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Week 12	2.7 Units on a scale	Standard Deviation 1.05
Vehicle QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Week 32	2.1 Units on a scale	Standard Deviation 0.8
Vehicle QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Week 28	2.4 Units on a scale	Standard Deviation 1.08
Vehicle QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Week 32	2.6 Units on a scale	Standard Deviation 1.07
Vehicle QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Week 52	2.1 Units on a scale	Standard Deviation 1
Vehicle QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Week 36	2.7 Units on a scale	Standard Deviation 1.15
Vehicle QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Week 44	2.3 Units on a scale	Standard Deviation 1.05
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Week 40	2.1 Units on a scale	Standard Deviation 0.67
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Baseline	2.5 Units on a scale	Standard Deviation 0.9
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Week 4	2.3 Units on a scale	Standard Deviation 0.97
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Week 8	2.2 Units on a scale	Standard Deviation 1.02
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Week 12	2.2 Units on a scale	Standard Deviation 0.98
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Week 16	2.3 Units on a scale	Standard Deviation 1.06
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Week 20	2.4 Units on a scale	Standard Deviation 1.23
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Week 24	2.4 Units on a scale	Standard Deviation 1.29
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Week 28	2.4 Units on a scale	Standard Deviation 1.21
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Week 32	2.4 Units on a scale	Standard Deviation 1.19
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Week 36	2.4 Units on a scale	Standard Deviation 1.29
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Week 40	2.4 Units on a scale	Standard Deviation 1.34
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Week 44	2.5 Units on a scale	Standard Deviation 1.21
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Week 48	2.4 Units on a scale	Standard Deviation 1.19
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Week 52	2.3 Units on a scale	Standard Deviation 1.26
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Baseline	2.6 Units on a scale	Standard Deviation 0.83
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Week 4	2.4 Units on a scale	Standard Deviation 0.93
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Week 8	2.4 Units on a scale	Standard Deviation 1.03
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Week 12	2.2 Units on a scale	Standard Deviation 0.73
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Week 16	2.1 Units on a scale	Standard Deviation 0.77
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Week 20	2.2 Units on a scale	Standard Deviation 0.88
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Week 24	2.3 Units on a scale	Standard Deviation 1.02
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Week 28	2.0 Units on a scale	Standard Deviation 0.66
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Week 32	2.1 Units on a scale	Standard Deviation 0.64
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Week 36	2.0 Units on a scale	Standard Deviation 0.58
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Week 44	2.0 Units on a scale	Standard Deviation 0.64
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Week 48	1.8 Units on a scale	Standard Deviation 0.53
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Week 52	1.7 Units on a scale	Standard Deviation 0.62
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Week 4	3.0 Units on a scale	Standard Deviation 0.88
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Week 20	2.7 Units on a scale	Standard Deviation 1.07
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Week 36	2.6 Units on a scale	Standard Deviation 1.25
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Week 44	3.0 Units on a scale	Standard Deviation 1.25
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Week 24	2.7 Units on a scale	Standard Deviation 0.76
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Week 32	2.7 Units on a scale	Standard Deviation 1.3
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Week 8	2.9 Units on a scale	Standard Deviation 1.1
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Week 28	2.5 Units on a scale	Standard Deviation 0.65
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Week 28	3.1 Units on a scale	Standard Deviation 1.31
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Week 52	2.6 Units on a scale	Standard Deviation 1.04
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Week 32	2.7 Units on a scale	Standard Deviation 0.79
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Week 24	2.7 Units on a scale	Standard Deviation 1.16
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Week 48	2.8 Units on a scale	Standard Deviation 0.95
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Week 36	2.9 Units on a scale	Standard Deviation 1.06
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Week 20	3.0 Units on a scale	Standard Deviation 1.19
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Week 4	3.0 Units on a scale	Standard Deviation 1.08
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Week 52	2.8 Units on a scale	Standard Deviation 0.35
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Week 16	2.9 Units on a scale	Standard Deviation 1.21
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Week 8	2.8 Units on a scale	Standard Deviation 1.1
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Week 48	2.5 Units on a scale	Standard Deviation 1.1
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Week 40	2.8 Units on a scale	Standard Deviation 1.18
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Week 12	2.9 Units on a scale	Standard Deviation 1.16
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Week 44	2.4 Units on a scale	Standard Deviation 0.74
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Week 12	3.1 Units on a scale	Standard Deviation 1.05
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	3 months to <12 years of age: Week 16	2.8 Units on a scale	Standard Deviation 1.13
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: DB Period	>= 12 years of age: Week 40	2.6 Units on a scale	Standard Deviation 1

Secondary

Patient/Observer Global Impression of Severity Score: First Flare Free Period

Time frame: Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	3 months to <12 years of age: Baseline	2.6 Units on a scale	Standard Deviation 0.99
Vehicle QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	>= 12 years of age: Week 16	2.6 Units on a scale	Standard Deviation 1.04
Vehicle QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	3 months to <12 years of age: Week 4	2.6 Units on a scale	Standard Deviation 1.14
Vehicle QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	>= 12 years of age: Week 32	2.6 Units on a scale	Standard Deviation 1.05
Vehicle QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	3 months to <12 years of age: Week 8	2.5 Units on a scale	Standard Deviation 1.28
Vehicle QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	>= 12 years of age: Week 4	2.7 Units on a scale	Standard Deviation 1.14
Vehicle QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	3 months to <12 years of age: Week 12	2.3 Units on a scale	Standard Deviation 1.12
Vehicle QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	>= 12 years of age: Week 36	2.7 Units on a scale	Standard Deviation 1.05
Vehicle QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	3 months to <12 years of age: Week 16	2.4 Units on a scale	Standard Deviation 1.14
Vehicle QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	>= 12 years of age: Week 20	2.7 Units on a scale	Standard Deviation 0.96
Vehicle QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	3 months to <12 years of age: Week 20	2.3 Units on a scale	Standard Deviation 1.24
Vehicle QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	>= 12 years of age: Week 40	2.7 Units on a scale	Standard Deviation 1.1
Vehicle QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	3 months to <12 years of age: Week 24	2.3 Units on a scale	Standard Deviation 1.47
Vehicle QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	>= 12 years of age: Week 12	2.6 Units on a scale	Standard Deviation 1.03
Vehicle QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	3 months to <12 years of age: Week 28	2.4 Units on a scale	Standard Deviation 1.59
Vehicle QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	>= 12 years of age: Week 44	2.7 Units on a scale	Standard Deviation 1.1
Vehicle QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	3 months to <12 years of age: Week 32	1.8 Units on a scale	Standard Deviation 0.75
Vehicle QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	>= 12 years of age: Week 24	2.7 Units on a scale	Standard Deviation 1.06
Vehicle QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	3 months to <12 years of age: Week 36	2.6 Units on a scale	Standard Deviation 1.77
Vehicle QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	>= 12 years of age: Week 48	2.6 Units on a scale	Standard Deviation 1.14
Vehicle QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	3 months to <12 years of age: Week 40	2.0 Units on a scale	Standard Deviation 0.99
Vehicle QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	>= 12 years of age: Week 8	2.6 Units on a scale	Standard Deviation 1
Vehicle QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	3 months to <12 years of age: Week 44	2.7 Units on a scale	Standard Deviation 1.66
Vehicle QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	>= 12 years of age: Week 52	2.6 Units on a scale	Standard Deviation 1.15
Vehicle QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	3 months to <12 years of age: Week 48	2.1 Units on a scale	Standard Deviation 0.92
Vehicle QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	>= 12 years of age: Week 28	2.7 Units on a scale	Standard Deviation 1.05
Vehicle QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	3 months to <12 years of age: Week 52	1.5 Units on a scale	Standard Deviation 0.5
Vehicle QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	>= 12 years of age: Baseline	2.6 Units on a scale	Standard Deviation 1.03
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	3 months to <12 years of age: Week 52	1.6 Units on a scale	Standard Deviation 0.65
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	>= 12 years of age: Baseline	2.5 Units on a scale	Standard Deviation 0.9
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	>= 12 years of age: Week 4	2.3 Units on a scale	Standard Deviation 0.98
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	>= 12 years of age: Week 8	2.3 Units on a scale	Standard Deviation 1.05
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	>= 12 years of age: Week 12	2.2 Units on a scale	Standard Deviation 1.03
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	>= 12 years of age: Week 16	2.1 Units on a scale	Standard Deviation 1
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	>= 12 years of age: Week 20	2.2 Units on a scale	Standard Deviation 1.1
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	>= 12 years of age: Week 24	2.2 Units on a scale	Standard Deviation 1.11
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	>= 12 years of age: Week 28	2.2 Units on a scale	Standard Deviation 1.07
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	>= 12 years of age: Week 32	2.1 Units on a scale	Standard Deviation 1.02
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	>= 12 years of age: Week 36	2.1 Units on a scale	Standard Deviation 1.08
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	>= 12 years of age: Week 40	2.1 Units on a scale	Standard Deviation 1.1
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	>= 12 years of age: Week 44	2.3 Units on a scale	Standard Deviation 1.24
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	>= 12 years of age: Week 48	2.3 Units on a scale	Standard Deviation 1.28
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	>= 12 years of age: Week 52	2.0 Units on a scale	Standard Deviation 1.25
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	3 months to <12 years of age: Baseline	2.6 Units on a scale	Standard Deviation 0.83
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	3 months to <12 years of age: Week 4	2.4 Units on a scale	Standard Deviation 0.93
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	3 months to <12 years of age: Week 8	2.3 Units on a scale	Standard Deviation 0.98
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	3 months to <12 years of age: Week 12	2.3 Units on a scale	Standard Deviation 0.78
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	3 months to <12 years of age: Week 16	2.0 Units on a scale	Standard Deviation 0.84
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	3 months to <12 years of age: Week 20	2.1 Units on a scale	Standard Deviation 0.83
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	3 months to <12 years of age: Week 24	1.9 Units on a scale	Standard Deviation 0.59
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	3 months to <12 years of age: Week 28	2.0 Units on a scale	Standard Deviation 0.57
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	3 months to <12 years of age: Week 32	2.1 Units on a scale	Standard Deviation 0.58
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	3 months to <12 years of age: Week 36	1.7 Units on a scale	Standard Deviation 0.56
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	3 months to <12 years of age: Week 40	1.8 Units on a scale	Standard Deviation 0.6
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	3 months to <12 years of age: Week 44	1.7 Units on a scale	Standard Deviation 0.56
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: First Flare Free Period	3 months to <12 years of age: Week 48	1.7 Units on a scale	Standard Deviation 0.41

Secondary

Patient/Observer Global Impression of Severity Score: First Flare Period

Time frame: Weeks 0, 4, 8 and 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Patient/Observer Global Impression of Severity Score: First Flare Period	>= 12 years of age: Week 0	2.8 Units on a scale	Standard Deviation 0.93
Vehicle QD	Patient/Observer Global Impression of Severity Score: First Flare Period	>= 12 years of age: Week 4	2.9 Units on a scale	Standard Deviation 0.98
Vehicle QD	Patient/Observer Global Impression of Severity Score: First Flare Period	>= 12 years of age: Week 8	3.1 Units on a scale	Standard Deviation 1.02
Vehicle QD	Patient/Observer Global Impression of Severity Score: First Flare Period	>= 12 years of age: Week 12	3.3 Units on a scale	Standard Deviation 1.56
Vehicle QD	Patient/Observer Global Impression of Severity Score: First Flare Period	3 months to <12 years of age: Week 0	2.8 Units on a scale	Standard Deviation 0.94
Vehicle QD	Patient/Observer Global Impression of Severity Score: First Flare Period	3 months to <12 years of age: Week 4	3.0 Units on a scale	Standard Deviation 1.19
Vehicle QD	Patient/Observer Global Impression of Severity Score: First Flare Period	3 months to <12 years of age: Week 8	2.9 Units on a scale	Standard Deviation 1.16
Vehicle QD	Patient/Observer Global Impression of Severity Score: First Flare Period	3 months to <12 years of age: Week 12	2.8 Units on a scale	Standard Deviation 0.95
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: First Flare Period	3 months to <12 years of age: Week 12	3.4 Units on a scale	Standard Deviation 0.79
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: First Flare Period	>= 12 years of age: Week 0	3.1 Units on a scale	Standard Deviation 1.1
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: First Flare Period	3 months to <12 years of age: Week 0	3.0 Units on a scale	Standard Deviation 0.79
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: First Flare Period	>= 12 years of age: Week 4	2.9 Units on a scale	Standard Deviation 1.14
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: First Flare Period	3 months to <12 years of age: Week 8	3.1 Units on a scale	Standard Deviation 1.03
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: First Flare Period	>= 12 years of age: Week 8	3.6 Units on a scale	Standard Deviation 1.17
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: First Flare Period	3 months to <12 years of age: Week 4	2.8 Units on a scale	Standard Deviation 0.9
Crisaborole 2% QD	Patient/Observer Global Impression of Severity Score: First Flare Period	>= 12 years of age: Week 12	3.1 Units on a scale	Standard Deviation 1.5

Secondary

Patient/Observer Global Impression of Severity Score: OL Run-in Period

Patient/Observer Global Impression of Severity (PGIS/OGIS) is a single item participant or observer rated measure of the participant's AD condition severity at a given point in time using a 7-point rating scale, which ranges from 1 to 7, where 1=not present to 7=extremely severe. The PGIS was completed by all participants \>=12 years of age and OGIS was completed by the observer for participants 3 months-\<12 years of age.

Time frame: Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Patient/Observer Global Impression of Severity Score: OL Run-in Period	>= 12 years of age: Baseline	3.8 Units on a scale	Standard Deviation 1.3
Vehicle QD	Patient/Observer Global Impression of Severity Score: OL Run-in Period	>= 12 years of age: Week 2	3.2 Units on a scale	Standard Deviation 1.08
Vehicle QD	Patient/Observer Global Impression of Severity Score: OL Run-in Period	>= 12 years of age: Week 4	3.1 Units on a scale	Standard Deviation 1.12
Vehicle QD	Patient/Observer Global Impression of Severity Score: OL Run-in Period	>= 12 years of age: Week 6	3.0 Units on a scale	Standard Deviation 1.16
Vehicle QD	Patient/Observer Global Impression of Severity Score: OL Run-in Period	>= 12 years of age: Week 8	3.0 Units on a scale	Standard Deviation 1.19
Vehicle QD	Patient/Observer Global Impression of Severity Score: OL Run-in Period	3 months to <12 years of age: Baseline	4.4 Units on a scale	Standard Deviation 1.2
Vehicle QD	Patient/Observer Global Impression of Severity Score: OL Run-in Period	3 months to <12 years of age: Week 2	3.3 Units on a scale	Standard Deviation 1.13
Vehicle QD	Patient/Observer Global Impression of Severity Score: OL Run-in Period	3 months to <12 years of age: Week 4	3.3 Units on a scale	Standard Deviation 1.15
Vehicle QD	Patient/Observer Global Impression of Severity Score: OL Run-in Period	3 months to <12 years of age: Week 6	3.2 Units on a scale	Standard Deviation 1.21
Vehicle QD	Patient/Observer Global Impression of Severity Score: OL Run-in Period	3 months to <12 years of age: Week 8	3.1 Units on a scale	Standard Deviation 1.19

Secondary

Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period

WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores=less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores= less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent activity impairment due to health problem calculated as: 100\*Q10/10, score ranged from 0-100%,higher numbers=greater impairment and less productivity.

Time frame: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 20	16.19 Percent activity impairment	Standard Deviation 22.017
Vehicle QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 4	10.31 Percent activity impairment	Standard Deviation 18.749
Vehicle QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 40	10.59 Percent activity impairment	Standard Deviation 18.081
Vehicle QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 24	8.38 Percent activity impairment	Standard Deviation 13.645
Vehicle QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 48	11.00 Percent activity impairment	Standard Deviation 16.263
Vehicle QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 36	11.18 Percent activity impairment	Standard Deviation 15.363
Vehicle QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 28	11.67 Percent activity impairment	Standard Deviation 16.891
Vehicle QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 12	10.31 Percent activity impairment	Standard Deviation 16.749
Vehicle QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 32	9.12 Percent activity impairment	Standard Deviation 17.815
Vehicle QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 52	7.50 Percent activity impairment	Standard Deviation 14.368
Vehicle QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 44	13.33 Percent activity impairment	Standard Deviation 21.693
Vehicle QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 16	10.00 Percent activity impairment	Standard Deviation 15.927
Vehicle QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 8	8.61 Percent activity impairment	Standard Deviation 13.555
Vehicle QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Baseline	8.99 Percent activity impairment	Standard Deviation 15.353
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 40	8.30 Percent activity impairment	Standard Deviation 17.235
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Baseline	10.90 Percent activity impairment	Standard Deviation 16.763
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 4	8.24 Percent activity impairment	Standard Deviation 13.222
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 8	7.20 Percent activity impairment	Standard Deviation 12.784
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 12	5.31 Percent activity impairment	Standard Deviation 13.087
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 16	7.12 Percent activity impairment	Standard Deviation 14.731
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 20	9.52 Percent activity impairment	Standard Deviation 21.089
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 24	5.74 Percent activity impairment	Standard Deviation 12.81
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 28	5.29 Percent activity impairment	Standard Deviation 12.805
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 32	6.89 Percent activity impairment	Standard Deviation 14.744
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 36	9.41 Percent activity impairment	Standard Deviation 13.449
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 44	7.65 Percent activity impairment	Standard Deviation 16.781
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 48	6.05 Percent activity impairment	Standard Deviation 13.997
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 52	7.21 Percent activity impairment	Standard Deviation 15.48
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 36	7.14 Percent activity impairment	Standard Deviation 9.512
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 20	13.64 Percent activity impairment	Standard Deviation 15.015
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 16	16.19 Percent activity impairment	Standard Deviation 26.168
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 40	8.75 Percent activity impairment	Standard Deviation 17.269
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 12	13.44 Percent activity impairment	Standard Deviation 15.368
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 4	15.88 Percent activity impairment	Standard Deviation 22.287
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 44	16.36 Percent activity impairment	Standard Deviation 21.106
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 8	16.58 Percent activity impairment	Standard Deviation 23.741
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 28	22.14 Percent activity impairment	Standard Deviation 21.187
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 52	8.00 Percent activity impairment	Standard Deviation 12.649
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 32	26.92 Percent activity impairment	Standard Deviation 33.76
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 24	16.43 Percent activity impairment	Standard Deviation 19.457
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 48	10.00 Percent activity impairment	Standard Deviation 15.954

Secondary

Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period

WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending (0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent activity impairment due to health problem calculated as: 100\*Q10/10, score ranged from 0-100%,higher numbers=greater impairment and less productivity.

Time frame: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Baseline	8.99 Percent activity impairment	Standard Deviation 15.353
Vehicle QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 4	11.00 Percent activity impairment	Standard Deviation 19.182
Vehicle QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 8	10.00 Percent activity impairment	Standard Deviation 15.275
Vehicle QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 12	10.50 Percent activity impairment	Standard Deviation 18.202
Vehicle QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 16	8.95 Percent activity impairment	Standard Deviation 15.949
Vehicle QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 20	15.00 Percent activity impairment	Standard Deviation 16.903
Vehicle QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 24	8.24 Percent activity impairment	Standard Deviation 13.339
Vehicle QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 28	17.14 Percent activity impairment	Standard Deviation 17.995
Vehicle QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 32	11.88 Percent activity impairment	Standard Deviation 22.574
Vehicle QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 36	15.00 Percent activity impairment	Standard Deviation 13.784
Vehicle QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 40	12.35 Percent activity impairment	Standard Deviation 17.864
Vehicle QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 44	15.71 Percent activity impairment	Standard Deviation 17.182
Vehicle QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 48	11.18 Percent activity impairment	Standard Deviation 16.539
Vehicle QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 52	12.00 Percent activity impairment	Standard Deviation 17.403
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 40	7.31 Percent activity impairment	Standard Deviation 16.385
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Baseline	10.90 Percent activity impairment	Standard Deviation 16.763
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 28	3.33 Percent activity impairment	Standard Deviation 7.071
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 4	8.24 Percent activity impairment	Standard Deviation 13.222
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 48	7.50 Percent activity impairment	Standard Deviation 16.485
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 8	7.27 Percent activity impairment	Standard Deviation 13.005
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 32	8.52 Percent activity impairment	Standard Deviation 17.255
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 12	5.50 Percent activity impairment	Standard Deviation 13.765
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 44	8.89 Percent activity impairment	Standard Deviation 16.915
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 16	8.11 Percent activity impairment	Standard Deviation 15.958
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 36	8.57 Percent activity impairment	Standard Deviation 8.997
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 20	9.23 Percent activity impairment	Standard Deviation 22.159
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 52	6.52 Percent activity impairment	Standard Deviation 16.951
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 24	5.81 Percent activity impairment	Standard Deviation 13.85

Secondary

Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period

WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent activity impairment due to health problem calculated as: 100\*Q10/10, scores ranged from 0-100%,higher numbers=greater impairment and less productivity.

Time frame: Weeks 0, 4, 8 and 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 0	14.88 Percent activity impairment	Standard Deviation 20.745
Vehicle QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 4	15.24 Percent activity impairment	Standard Deviation 20.401
Vehicle QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 8	13.85 Percent activity impairment	Standard Deviation 17.578
Vehicle QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 12	16.67 Percent activity impairment	Standard Deviation 20.817
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 12	31.43 Percent activity impairment	Standard Deviation 29.681
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 0	17.27 Percent activity impairment	Standard Deviation 23.164
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 8	26.00 Percent activity impairment	Standard Deviation 28.486
Crisaborole 2% QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 4	19.17 Percent activity impairment	Standard Deviation 21.653

Secondary

Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period

WPAI+CIQ: 10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions:Q1=currently employed;Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores=less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores= less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent activity impairment due to health problem calculated as: 100\*Q10/10, score ranged from 0-100%,higher numbers=greater impairment and less productivity.

Time frame: Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period	Week 8	13.55 Percent activity impairment	Standard Deviation 19.783
Vehicle QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period	Baseline	28.21 Percent activity impairment	Standard Deviation 28.766
Vehicle QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period	Week 2	15.83 Percent activity impairment	Standard Deviation 20.036
Vehicle QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period	Week 4	14.54 Percent activity impairment	Standard Deviation 20.162
Vehicle QD	Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period	Week 6	13.81 Percent activity impairment	Standard Deviation 20.547

Secondary

Percent Change From Baseline in EASI Scores at Weeks 0, 4, 8 and 12: First Flare Treatment Period

EASI assessed severity of AD, based on severity of lesion clinical signs (erythema \[E\], induration/papulation \[I\], excoriation \[Ex\], lichenification \[L\]) and % body surface area (BSA) affected. Each of clinical signs scored separately for each of 4 body regions (head and neck \[h\], upper limbs \[u\], trunk \[t\] \[including axillae and groin\], lower limbs \[l\] \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score (A) according to % BSA with AD: 0 (0%), 1(\>0 to \<10%), 2(10 to \<30%), 3(30 to \<50%), 4(50 to \<70%), 5(70 to \<90%), 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh + Ih + Exh + Lh) + 0.2\*Au\*(Eu + Iu + ExU + Lu) + 0.3\*At\*(Et +It + Ext + Lt) + 0.4\*Al\*(El + Il + Exl + Ll). Total EASI score ranged from 0.0 to 72.0, higher score = greater severity of AD.

Time frame: Baseline (last observation up to and including the randomization day of DB period),Weeks 0, 4, 8 and 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Percent Change From Baseline in EASI Scores at Weeks 0, 4, 8 and 12: First Flare Treatment Period	Week 4	294.83 Percent change	Standard Deviation 350.182
Vehicle QD	Percent Change From Baseline in EASI Scores at Weeks 0, 4, 8 and 12: First Flare Treatment Period	Week 0	484.69 Percent change	Standard Deviation 672.923
Vehicle QD	Percent Change From Baseline in EASI Scores at Weeks 0, 4, 8 and 12: First Flare Treatment Period	Week 8	245.70 Percent change	Standard Deviation 411.541
Vehicle QD	Percent Change From Baseline in EASI Scores at Weeks 0, 4, 8 and 12: First Flare Treatment Period	Week 12	196.69 Percent change	Standard Deviation 272.911
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 0, 4, 8 and 12: First Flare Treatment Period	Week 12	408.94 Percent change	Standard Deviation 665.204
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 0, 4, 8 and 12: First Flare Treatment Period	Week 0	324.54 Percent change	Standard Deviation 484.38
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 0, 4, 8 and 12: First Flare Treatment Period	Week 4	293.63 Percent change	Standard Deviation 461.044
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 0, 4, 8 and 12: First Flare Treatment Period	Week 8	275.66 Percent change	Standard Deviation 447.181

Secondary

Percent Change From Baseline in EASI Scores at Weeks 2, 4, 6 and 8: OL Run-in Period

Time frame: Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8

Population: Evaluable-OL (Eval-OL) population included all participants that received at least 1 dose of study intervention in the OL period.

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Percent Change From Baseline in EASI Scores at Weeks 2, 4, 6 and 8: OL Run-in Period	Week 2	-31.44 Percent change	Standard Deviation 37.151
Vehicle QD	Percent Change From Baseline in EASI Scores at Weeks 2, 4, 6 and 8: OL Run-in Period	Week 4	-38.52 Percent change	Standard Deviation 44.448
Vehicle QD	Percent Change From Baseline in EASI Scores at Weeks 2, 4, 6 and 8: OL Run-in Period	Week 6	-45.35 Percent change	Standard Deviation 49.453
Vehicle QD	Percent Change From Baseline in EASI Scores at Weeks 2, 4, 6 and 8: OL Run-in Period	Week 8	-52.86 Percent change	Standard Deviation 51.209

Secondary

Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period

Time frame: Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period	Week 48	-22.23 Percent change	Standard Deviation 87.761
Vehicle QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period	Week 36	-55.95 Percent change	Standard Deviation 51.052
Vehicle QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period	Week 24	-20.62 Percent change	Standard Deviation 78.665
Vehicle QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period	Week 12	-0.11 Percent change	Standard Deviation 126.465
Vehicle QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period	Week 32	13.57 Percent change	Standard Deviation 131.633
Vehicle QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period	Week 28	19.17 Percent change	Standard Deviation 112.841
Vehicle QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period	Week 4	2.87 Percent change	Standard Deviation 72.981
Vehicle QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period	Week 8	1.04 Percent change	Standard Deviation 95.062
Vehicle QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period	Week 44	-59.74 Percent change	Standard Deviation 34.119
Vehicle QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period	Week 16	26.30 Percent change	Standard Deviation 156.188
Vehicle QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period	Week 52	-39.27 Percent change	Standard Deviation 72.619
Vehicle QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period	Week 40	10.00 Percent change	Standard Deviation 142.168
Vehicle QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period	Week 20	26.38 Percent change	Standard Deviation 147.113
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period	Week 28	-33.04 Percent change	Standard Deviation 31.617
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period	Week 4	-10.16 Percent change	Standard Deviation 61.161
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period	Week 8	34.26 Percent change	Standard Deviation 224.615
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period	Week 12	-8.22 Percent change	Standard Deviation 93.118
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period	Week 16	27.98 Percent change	Standard Deviation 282.035
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period	Week 20	-45.44 Percent change	Standard Deviation 54.768
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period	Week 24	6.94 Percent change	Standard Deviation 162.911
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period	Week 32	-19.33 Percent change	Standard Deviation 81.663
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period	Week 36	211.13 Percent change	Standard Deviation 155.547
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period	Week 40	-12.94 Percent change	Standard Deviation 148.586
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period	Week 44	127.56 Percent change	Standard Deviation 322.953
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period	Week 48	-30.01 Percent change	Standard Deviation 72.497
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period	Week 52	-49.81 Percent change	Standard Deviation 56.391
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period	Week 36	184.26 Percent change	Standard Deviation 195.695
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period	Week 16	272.90 Percent change	Standard Deviation 314.387
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period	Week 48	390.33 Percent change	Standard Deviation 502.931
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period	Week 40	330.78 Percent change	Standard Deviation 447.039
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period	Week 12	401.37 Percent change	Standard Deviation 937.078
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period	Week 4	407.52 Percent change	Standard Deviation 562.691
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period	Week 44	444.00 Percent change	Standard Deviation 505.329
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period	Week 28	453.99 Percent change	Standard Deviation 848.739
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period	Week 24	270.22 Percent change	Standard Deviation 314.301
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period	Week 8	239.90 Percent change	Standard Deviation 321.514
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period	Week 32	341.18 Percent change	Standard Deviation 500.843
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period	Week 20	264.70 Percent change	Standard Deviation 341.948
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period	Week 52	250.13 Percent change	Standard Deviation 497.782

Secondary

Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period

Time frame: Baseline (last observation up to and including the randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period	Week 4	-0.46 Percent change	Standard Deviation 67.355
Vehicle QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period	Week 12	2.24 Percent change	Standard Deviation 143.094
Vehicle QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period	Week 16	-14.82 Percent change	Standard Deviation 50.412
Vehicle QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period	Week 20	200.00 Percent change	—
Vehicle QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period	Week 24	-35.57 Percent change	Standard Deviation 55.674
Vehicle QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period	Week 28	0.00 Percent change	—
Vehicle QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period	Week 32	-28.39 Percent change	Standard Deviation 62.657
Vehicle QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period	Week 36	-67.86 Percent change	—
Vehicle QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period	Week 40	2.19 Percent change	Standard Deviation 83.621
Vehicle QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period	Week 44	-36.84 Percent change	—
Vehicle QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period	Week 48	-27.27 Percent change	Standard Deviation 61.689
Vehicle QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period	Week 52	-54.33 Percent change	Standard Deviation 45.072
Vehicle QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period	Week 8	-21.34 Percent change	Standard Deviation 59.257
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period	Week 4	-10.34 Percent change	Standard Deviation 61.699
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period	Week 52	-59.87 Percent change	Standard Deviation 58.964
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period	Week 8	10.36 Percent change	Standard Deviation 144.77
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period	Week 28	-34.52 Percent change	Standard Deviation 48.824
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period	Week 12	-9.44 Percent change	Standard Deviation 100.314
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period	Week 40	-47.60 Percent change	Standard Deviation 64.625
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period	Week 16	-0.47 Percent change	Standard Deviation 109.386
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period	Week 32	-27.82 Percent change	Standard Deviation 94.806
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period	Week 20	-74.29 Percent change	Standard Deviation 40.808
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period	Week 48	-39.13 Percent change	Standard Deviation 82.669
Crisaborole 2% QD	Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period	Week 24	-10.82 Percent change	Standard Deviation 109.364

Secondary

Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period

WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working(0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores= less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent class time missed due to health problem calculated as: Q7\*100/(Q7+Q8) and score ranged from 0-100% where higher numbers=greater impairment and less productivity.

Time frame: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Baseline	0.04 Percent class time missed	Standard Deviation 0.223
Vehicle QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 4	0.89 Percent class time missed	Standard Deviation 3.089
Vehicle QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 8	0.00 Percent class time missed	Standard Deviation 0
Vehicle QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 12	11.36 Percent class time missed	Standard Deviation 32.138
Vehicle QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 16	0.00 Percent class time missed	Standard Deviation 0
Vehicle QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 20	7.79 Percent class time missed	Standard Deviation 20.599
Vehicle QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 24	0.00 Percent class time missed	Standard Deviation 0
Vehicle QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 28	0.00 Percent class time missed	Standard Deviation 0
Vehicle QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 32	0.00 Percent class time missed	Standard Deviation 0
Vehicle QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 36	0.00 Percent class time missed	Standard Deviation 0
Vehicle QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 40	0.00 Percent class time missed	Standard Deviation 0
Vehicle QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 44	0.00 Percent class time missed	Standard Deviation 0
Vehicle QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 48	11.11 Percent class time missed	Standard Deviation 33.333
Vehicle QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 52	5.71 Percent class time missed	Standard Deviation 15.119
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 36	0.00 Percent class time missed	Standard Deviation 0
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 4	1.14 Percent class time missed	Standard Deviation 5.33
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 44	0.00 Percent class time missed	Standard Deviation 0
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 28	0.00 Percent class time missed	Standard Deviation 0
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 8	1.62 Percent class time missed	Standard Deviation 6.735
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 24	3.62 Percent class time missed	Standard Deviation 9.881
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 52	9.09 Percent class time missed	Standard Deviation 25.054
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 12	3.09 Percent class time missed	Standard Deviation 11.781
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 32	5.83 Percent class time missed	Standard Deviation 15.897
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 40	3.57 Percent class time missed	Standard Deviation 13.363
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 16	7.64 Percent class time missed	Standard Deviation 23.561
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 20	0.00 Percent class time missed	Standard Deviation 0
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 48	0.00 Percent class time missed	Standard Deviation 0
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Baseline	2.22 Percent class time missed	Standard Deviation 9.03
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 16	0.81 Percent class time missed	Standard Deviation 2.154
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 20	25.00 Percent class time missed	Standard Deviation 50
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 24	0.00 Percent class time missed	Standard Deviation 0
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 44	0.00 Percent class time missed	Standard Deviation 0
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 28	0.00 Percent class time missed	Standard Deviation 0
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 32	0.00 Percent class time missed	Standard Deviation 0
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 4	5.96 Percent class time missed	Standard Deviation 14.57
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 36	0.00 Percent class time missed	Standard Deviation 0
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 8	7.95 Percent class time missed	Standard Deviation 18.375
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 48	10.00 Percent class time missed	Standard Deviation 22.361
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 12	7.14 Percent class time missed	Standard Deviation 18.898
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 52	0.00 Percent class time missed	Standard Deviation 0

Secondary

Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period

WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working(0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent class time missed due to health problem calculated as: Q7\*100/(Q7+Q8) and score ranged from 0-100% where higher numbers=greater impairment and less productivity.

Time frame: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 16	0.00 Percent class time missed	Standard Deviation 0
Vehicle QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 32	0.00 Percent class time missed	Standard Deviation 0
Vehicle QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 4	0.97 Percent class time missed	Standard Deviation 3.226
Vehicle QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 20	0.00 Percent class time missed	—
Vehicle QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 40	0.00 Percent class time missed	Standard Deviation 0
Vehicle QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 12	0.00 Percent class time missed	Standard Deviation 0
Vehicle QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 44	0.00 Percent class time missed	—
Vehicle QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 24	0.00 Percent class time missed	Standard Deviation 0
Vehicle QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 48	0.00 Percent class time missed	Standard Deviation 0
Vehicle QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 8	0.00 Percent class time missed	Standard Deviation 0
Vehicle QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 52	0.00 Percent class time missed	Standard Deviation 0
Vehicle QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Baseline	0.04 Percent class time missed	Standard Deviation 0.223
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 44	0.00 Percent class time missed	Standard Deviation 0
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 48	0.00 Percent class time missed	Standard Deviation 0
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 52	0.00 Percent class time missed	Standard Deviation 0
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Baseline	2.22 Percent class time missed	Standard Deviation 9.03
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 4	1.14 Percent class time missed	Standard Deviation 5.33
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 8	1.62 Percent class time missed	Standard Deviation 6.735
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 12	3.27 Percent class time missed	Standard Deviation 12.118
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 16	8.22 Percent class time missed	Standard Deviation 24.416
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 20	0.00 Percent class time missed	Standard Deviation 0
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 24	0.71 Percent class time missed	Standard Deviation 2.673
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 28	0.00 Percent class time missed	Standard Deviation 0
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 32	8.97 Percent class time missed	Standard Deviation 19.226
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 36	0.00 Percent class time missed	Standard Deviation 0
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 40	0.00 Percent class time missed	Standard Deviation 0

Secondary

Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period

WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent class time missed due to health problem calculated as: Q7\*100/(Q7+Q8) and score ranged from 0-100% where higher numbers=greater impairment and less productivity.

Time frame: Weeks 0, 4, 8 and 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 8	0.00 Percent class time missed	Standard Deviation 0
Vehicle QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 4	0.00 Percent class time missed	Standard Deviation 0
Vehicle QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 0	3.98 Percent class time missed	Standard Deviation 12.314
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 12	1.43 Percent class time missed	Standard Deviation 2.85
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 4	6.82 Percent class time missed	Standard Deviation 16.215
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 0	11.53 Percent class time missed	Standard Deviation 27.668
Crisaborole 2% QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 8	8.33 Percent class time missed	Standard Deviation 20.412

Secondary

Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period

WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores=less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores= less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity).Percent class time missed due to health problem calculated as: Q7\*100/(Q7+Q8) and score ranged from 0-100% where higher numbers=greater impairment and less productivity.

Time frame: Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period	Baseline	4.14 Percent class time missed	Standard Deviation 14.982
Vehicle QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period	Week 2	5.26 Percent class time missed	Standard Deviation 16.664
Vehicle QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period	Week 4	3.94 Percent class time missed	Standard Deviation 12.968
Vehicle QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period	Week 6	4.71 Percent class time missed	Standard Deviation 13.991
Vehicle QD	Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period	Week 8	4.55 Percent class time missed	Standard Deviation 14.584

Secondary

Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period

WPAI+CIQ: 10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, high scores=less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities (0-10 scale, high scores =less productivity). Percent impairment while in class was calculated as: 100\*Q9/10 and score ranged from 0-100% where higher numbers indicate greater impairment and less productivity.

Time frame: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Baseline	8.62 Percent impairment while in class	Standard Deviation 14.072
Vehicle QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 4	5.83 Percent impairment while in class	Standard Deviation 12.401
Vehicle QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 8	4.17 Percent impairment while in class	Standard Deviation 7.93
Vehicle QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 12	3.75 Percent impairment while in class	Standard Deviation 7.44
Vehicle QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 16	7.78 Percent impairment while in class	Standard Deviation 16.415
Vehicle QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 20	11.43 Percent impairment while in class	Standard Deviation 16.762
Vehicle QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 24	8.75 Percent impairment while in class	Standard Deviation 18.077
Vehicle QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 28	10.00 Percent impairment while in class	Standard Deviation 22.361
Vehicle QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 32	3.75 Percent impairment while in class	Standard Deviation 10.607
Vehicle QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 36	2.50 Percent impairment while in class	Standard Deviation 5
Vehicle QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 40	2.00 Percent impairment while in class	Standard Deviation 4.472
Vehicle QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 44	10.00 Percent impairment while in class	Standard Deviation 14.142
Vehicle QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 48	7.50 Percent impairment while in class	Standard Deviation 13.887
Vehicle QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 52	1.43 Percent impairment while in class	Standard Deviation 3.78
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 36	2.50 Percent impairment while in class	Standard Deviation 5
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 4	6.36 Percent impairment while in class	Standard Deviation 12.168
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 44	6.67 Percent impairment while in class	Standard Deviation 8.165
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 28	7.14 Percent impairment while in class	Standard Deviation 11.127
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 8	5.79 Percent impairment while in class	Standard Deviation 8.377
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 24	4.00 Percent impairment while in class	Standard Deviation 7.539
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 52	7.62 Percent impairment while in class	Standard Deviation 14.458
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 12	2.22 Percent impairment while in class	Standard Deviation 7.321
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 32	3.50 Percent impairment while in class	Standard Deviation 9.333
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 40	8.57 Percent impairment while in class	Standard Deviation 14.064
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 16	8.57 Percent impairment while in class	Standard Deviation 10.271
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 20	11.11 Percent impairment while in class	Standard Deviation 26.667
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 48	7.06 Percent impairment while in class	Standard Deviation 12.127
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Baseline	7.88 Percent impairment while in class	Standard Deviation 11.39
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 16	24.29 Percent impairment while in class	Standard Deviation 29.358
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 20	10.00 Percent impairment while in class	Standard Deviation 10
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 24	15.00 Percent impairment while in class	Standard Deviation 23.805
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 44	16.67 Percent impairment while in class	Standard Deviation 5.774
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 28	21.43 Percent impairment while in class	Standard Deviation 21.157
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 32	20.00 Percent impairment while in class	Standard Deviation 25.166
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 4	29.33 Percent impairment while in class	Standard Deviation 26.583
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 36	20.00 Percent impairment while in class	Standard Deviation 28.284
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 8	19.17 Percent impairment while in class	Standard Deviation 23.916
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 48	8.00 Percent impairment while in class	Standard Deviation 8.367
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 12	24.29 Percent impairment while in class	Standard Deviation 17.182
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 52	5.56 Percent impairment while in class	Standard Deviation 8.819

Secondary

Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period

WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending (0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent impairment while in class was calculated as: 100\*Q9/10 and score ranged from 0-100% where higher numbers indicate greater impairment and less productivity.

Time frame: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 16	2.50 Percent impairment while in class	Standard Deviation 5
Vehicle QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 32	0.00 Percent impairment while in class	Standard Deviation 0
Vehicle QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 4	6.36 Percent impairment while in class	Standard Deviation 12.863
Vehicle QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 20	0.00 Percent impairment while in class	—
Vehicle QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 40	5.00 Percent impairment while in class	Standard Deviation 7.071
Vehicle QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 12	5.00 Percent impairment while in class	Standard Deviation 10
Vehicle QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 44	20.00 Percent impairment while in class	—
Vehicle QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 24	10.00 Percent impairment while in class	Standard Deviation 14.142
Vehicle QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 48	7.50 Percent impairment while in class	Standard Deviation 15
Vehicle QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 8	1.43 Percent impairment while in class	Standard Deviation 3.78
Vehicle QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 52	0.00 Percent impairment while in class	Standard Deviation 0
Vehicle QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Baseline	8.62 Percent impairment while in class	Standard Deviation 14.072
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 44	10.00 Percent impairment while in class	Standard Deviation 10
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 48	5.56 Percent impairment while in class	Standard Deviation 11.304
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 52	3.33 Percent impairment while in class	Standard Deviation 7.071
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Baseline	7.88 Percent impairment while in class	Standard Deviation 11.39
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 4	6.36 Percent impairment while in class	Standard Deviation 12.168
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 8	5.79 Percent impairment while in class	Standard Deviation 8.377
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 12	2.35 Percent impairment while in class	Standard Deviation 7.524
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 16	8.46 Percent impairment while in class	Standard Deviation 10.682
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 20	14.29 Percent impairment while in class	Standard Deviation 29.921
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 24	2.86 Percent impairment while in class	Standard Deviation 6.112
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 28	10.00 Percent impairment while in class	Standard Deviation 14.142
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 32	3.85 Percent impairment while in class	Standard Deviation 11.209
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 36	5.00 Percent impairment while in class	Standard Deviation 7.071
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 40	6.25 Percent impairment while in class	Standard Deviation 9.161

Secondary

Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period

WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions:Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent impairment while in class was calculated as: 100\*Q9/10 and score ranged from 0-100% where higher numbers indicate greater impairment and less productivity.

Time frame: Weeks 0, 4, 8 and 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 8	30.00 Percent impairment while in class	Standard Deviation 14.142
Vehicle QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 4	16.67 Percent impairment while in class	Standard Deviation 13.663
Vehicle QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 0	13.85 Percent impairment while in class	Standard Deviation 17.578
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 12	40.00 Percent impairment while in class	Standard Deviation 28.284
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 4	25.00 Percent impairment while in class	Standard Deviation 25.761
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 0	24.67 Percent impairment while in class	Standard Deviation 28.999
Crisaborole 2% QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 8	30.00 Percent impairment while in class	Standard Deviation 26.077

Secondary

Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period

WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, high scores=less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending (0-10 scale, high scores= less productivity); Q10=degree health affected productivity in regular daily activities (0-10 scale, high scores =less productivity). Percent impairment while in class was calculated as: 100\*Q9/10 and score ranged from 0-100% where higher numbers indicate greater impairment and less productivity.

Time frame: Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period	Baseline	26.46 Percent impairment in class	Standard Deviation 22.683
Vehicle QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period	Week 2	17.55 Percent impairment in class	Standard Deviation 19.639
Vehicle QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period	Week 4	15.37 Percent impairment in class	Standard Deviation 19.879
Vehicle QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period	Week 6	13.31 Percent impairment in class	Standard Deviation 19.527
Vehicle QD	Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period	Week 8	12.69 Percent impairment in class	Standard Deviation 17.789

Secondary

Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period

WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions:Q1=currently employed; Q2=hours missed due to health problems; Q3=hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores=less productivity); Q6=classes attended in academic setting or not; Q7=hours missed due to health problems; Q8=hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores= less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent impairment while working due to health problem calculated as: 100\*Q5/10 score ranged from 0-100%,higher numbers=greater impairment and less productivity.

Time frame: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 4	4.55 Percent impairment while work	Standard Deviation 12.136
Vehicle QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 20	11.25 Percent impairment while work	Standard Deviation 15.526
Vehicle QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 48	9.17 Percent impairment while work	Standard Deviation 9.003
Vehicle QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Baseline	9.71 Percent impairment while work	Standard Deviation 15.432
Vehicle QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 24	8.00 Percent impairment while work	Standard Deviation 8.619
Vehicle QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 40	9.33 Percent impairment while work	Standard Deviation 10.998
Vehicle QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 8	6.15 Percent impairment while work	Standard Deviation 7.679
Vehicle QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 28	12.00 Percent impairment while work	Standard Deviation 13.038
Vehicle QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 52	8.00 Percent impairment while work	Standard Deviation 9.411
Vehicle QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 44	21.67 Percent impairment while work	Standard Deviation 32.506
Vehicle QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 32	7.69 Percent impairment while work	Standard Deviation 8.321
Vehicle QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 16	11.76 Percent impairment while work	Standard Deviation 15.506
Vehicle QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 12	6.92 Percent impairment while work	Standard Deviation 8.549
Vehicle QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 36	10.00 Percent impairment while work	Standard Deviation 10
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 4	10.56 Percent impairment while work	Standard Deviation 15.136
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 40	10.56 Percent impairment while work	Standard Deviation 19.844
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 12	8.00 Percent impairment while work	Standard Deviation 20.771
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 44	11.67 Percent impairment while work	Standard Deviation 24.014
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 48	13.33 Percent impairment while work	Standard Deviation 21.269
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 52	10.63 Percent impairment while work	Standard Deviation 20.484
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 16	5.24 Percent impairment while work	Standard Deviation 14.359
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 36	10.00 Percent impairment while work	Standard Deviation 10
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 20	3.33 Percent impairment while work	Standard Deviation 5.164
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 24	8.89 Percent impairment while work	Standard Deviation 20.26
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 28	0.00 Percent impairment while work	Standard Deviation 0
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 8	5.29 Percent impairment while work	Standard Deviation 12.805
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 32	9.41 Percent impairment while work	Standard Deviation 15.996
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Baseline	10.26 Percent impairment while work	Standard Deviation 17.474
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 52	10.00 Percent impairment while work	Standard Deviation 10
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 4	15.22 Percent impairment while work	Standard Deviation 25.561
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 8	9.38 Percent impairment while work	Standard Deviation 16.52
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 12	7.78 Percent impairment while work	Standard Deviation 13.017
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 16	11.25 Percent impairment while work	Standard Deviation 21.002
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 20	10.00 Percent impairment while work	Standard Deviation 12.247
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 24	10.00 Percent impairment while work	Standard Deviation 17.321
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 28	5.00 Percent impairment while work	Standard Deviation 5.774
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 32	0.00 Percent impairment while work	Standard Deviation 0
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 36	2.50 Percent impairment while work	Standard Deviation 5
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 40	6.67 Percent impairment while work	Standard Deviation 11.547
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 44	5.00 Percent impairment while work	Standard Deviation 10
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 48	15.00 Percent impairment while work	Standard Deviation 22.583

Secondary

Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period

WPAI+CIQ: 10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=hours missed due to health problems; Q3=hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=hours missed due to health problems; Q8=hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent impairment while working due to health problem calculated as: 100\*Q5/10 score ranged from 0-100%, higher numbers=greater impairment and less productivity.

Time frame: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Baseline	9.71 Percent impairment while work	Standard Deviation 15.432
Vehicle QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 4	5.00 Percent impairment while work	Standard Deviation 12.693
Vehicle QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 8	4.44 Percent impairment while work	Standard Deviation 5.27
Vehicle QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 12	5.71 Percent impairment while work	Standard Deviation 7.868
Vehicle QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 16	8.33 Percent impairment while work	Standard Deviation 11.69
Vehicle QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 20	15.00 Percent impairment while work	Standard Deviation 21.213
Vehicle QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 24	8.57 Percent impairment while work	Standard Deviation 8.997
Vehicle QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 28	10.00 Percent impairment while work	Standard Deviation 14.142
Vehicle QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 32	8.33 Percent impairment while work	Standard Deviation 7.528
Vehicle QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 36	10.00 Percent impairment while work	Standard Deviation 14.142
Vehicle QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 40	12.86 Percent impairment while work	Standard Deviation 11.127
Vehicle QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 44	30.00 Percent impairment while work	Standard Deviation 43.589
Vehicle QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 48	11.43 Percent impairment while work	Standard Deviation 8.997
Vehicle QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 52	8.33 Percent impairment while work	Standard Deviation 7.528
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 40	14.55 Percent impairment while work	Standard Deviation 23.394
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Baseline	10.26 Percent impairment while work	Standard Deviation 17.474
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 28	0.00 Percent impairment while work	Standard Deviation 0
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 4	10.56 Percent impairment while work	Standard Deviation 15.136
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 48	16.00 Percent impairment while work	Standard Deviation 24.585
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 8	6.43 Percent impairment while work	Standard Deviation 13.927
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 32	15.00 Percent impairment while work	Standard Deviation 19.003
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 12	12.00 Percent impairment while work	Standard Deviation 24.855
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 44	23.33 Percent impairment while work	Standard Deviation 32.146
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 16	7.86 Percent impairment while work	Standard Deviation 17.177
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 36	10.00 Percent impairment while work	Standard Deviation 10
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 20	6.67 Percent impairment while work	Standard Deviation 5.774
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 52	15.56 Percent impairment while work	Standard Deviation 25.055
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 24	13.00 Percent impairment while work	Standard Deviation 25.408

Secondary

Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period

WPAI+CIQ: 10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were: Q1=currently employed; Q2=hours missed due to health problems; Q3=hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=hours missed due to health problems; Q8=hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities (0-10 scale, high scores =less productivity). Percent impairment while working due to health problem calculated as: 100\*Q5/10 score ranged from 0-100%, higher numbers=greater impairment and less productivity.

Time frame: Weeks 0, 4, 8 and 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 0	11.05 Percent impairment while work	Standard Deviation 14.868
Vehicle QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 4	12.00 Percent impairment while work	Standard Deviation 18.738
Vehicle QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 8	8.00 Percent impairment while work	Standard Deviation 17.889
Vehicle QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 12	50.00 Percent impairment while work	Standard Deviation 14.142
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 12	0.00 Percent impairment while work	—
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 0	16.67 Percent impairment while work	Standard Deviation 31.547
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 8	15.00 Percent impairment while work	Standard Deviation 21.213
Crisaborole 2% QD	Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 4	10.00 Percent impairment while work	Standard Deviation 10

Secondary

Percent Impairment While Working Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period

WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were:Q1= currently employed;Q2= work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4= hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, high scores=less productivity);Q6=classes attended in academic setting or not;Q7= class hours missed due to health problems; Q8= class hours actually attended; Q9= degree health affected productivity while attending(0-10 scale, high scores= less productivity); Q10= degree health affected productivity in regular daily activities (0-10 scale, high scores=less productivity). Percent impairment while working due to health problem was calculated as: 100\*Q5/10 and score ranged from 0-100%,higher scores =greater impairment and less productivity.

Time frame: Weeks 0, 2, 4, 6 and 8

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Percent Impairment While Working Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period	Week 0	32.66 Percentage of work impairment	Standard Deviation 28.602
Vehicle QD	Percent Impairment While Working Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period	Week 2	17.02 Percentage of work impairment	Standard Deviation 21.293
Vehicle QD	Percent Impairment While Working Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period	Week 4	15.26 Percentage of work impairment	Standard Deviation 20.285
Vehicle QD	Percent Impairment While Working Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period	Week 6	14.10 Percentage of work impairment	Standard Deviation 20.417
Vehicle QD	Percent Impairment While Working Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period	Week 8	14.37 Percentage of work impairment	Standard Deviation 20.898

Secondary

Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period

WPAI+CIQ: 10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities (0-10 scale, high scores =less productivity). Percent overall class impairment due to health problem calculated as: 100\*{Q7/(Q7+Q8)+\[(1- Q7/(Q7+Q8))×(Q9/10)\]}, score range:0-100%, higher numbers=greater impairment and less productivity.

Time frame: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Baseline	8.64 Percent overall class impairment	Standard Deviation 14.136
Vehicle QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 4	6.37 Percent overall class impairment	Standard Deviation 14.034
Vehicle QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 8	4.17 Percent overall class impairment	Standard Deviation 7.93
Vehicle QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 12	15.11 Percent overall class impairment	Standard Deviation 31.477
Vehicle QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 16	7.78 Percent overall class impairment	Standard Deviation 16.415
Vehicle QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 20	18.44 Percent overall class impairment	Standard Deviation 24.535
Vehicle QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 24	8.75 Percent overall class impairment	Standard Deviation 18.077
Vehicle QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 28	10.00 Percent overall class impairment	Standard Deviation 22.361
Vehicle QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 32	3.75 Percent overall class impairment	Standard Deviation 10.607
Vehicle QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 36	2.50 Percent overall class impairment	Standard Deviation 5
Vehicle QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 40	2.00 Percent overall class impairment	Standard Deviation 4.472
Vehicle QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 44	10.00 Percent overall class impairment	Standard Deviation 14.142
Vehicle QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 48	7.50 Percent overall class impairment	Standard Deviation 13.887
Vehicle QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 52	7.14 Percent overall class impairment	Standard Deviation 14.96
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 36	2.50 Percent overall class impairment	Standard Deviation 5
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 4	7.50 Percent overall class impairment	Standard Deviation 12.701
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 44	6.67 Percent overall class impairment	Standard Deviation 8.165
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 28	7.14 Percent overall class impairment	Standard Deviation 11.127
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 8	7.40 Percent overall class impairment	Standard Deviation 9.858
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 24	7.20 Percent overall class impairment	Standard Deviation 13.26
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 52	11.90 Percent overall class impairment	Standard Deviation 20.154
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 12	5.28 Percent overall class impairment	Standard Deviation 13.559
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 32	9.06 Percent overall class impairment	Standard Deviation 18.186
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 40	11.79 Percent overall class impairment	Standard Deviation 18.771
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 16	14.06 Percent overall class impairment	Standard Deviation 24.697
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 20	11.11 Percent overall class impairment	Standard Deviation 26.667
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 48	7.06 Percent overall class impairment	Standard Deviation 12.127
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Baseline	10.10 Percent overall class impairment	Standard Deviation 13.237
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 16	24.44 Percent overall class impairment	Standard Deviation 29.707
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 20	10.00 Percent overall class impairment	Standard Deviation 10
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 24	15.00 Percent overall class impairment	Standard Deviation 23.805
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 44	16.67 Percent overall class impairment	Standard Deviation 5.774
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 28	21.43 Percent overall class impairment	Standard Deviation 21.157
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 32	20.00 Percent overall class impairment	Standard Deviation 25.166
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 4	30.69 Percent overall class impairment	Standard Deviation 27.265
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 36	20.00 Percent overall class impairment	Standard Deviation 28.284
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 8	26.68 Percent overall class impairment	Standard Deviation 25.384
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 48	17.00 Percent overall class impairment	Standard Deviation 22.804
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 12	27.86 Percent overall class impairment	Standard Deviation 24.471
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 52	5.56 Percent overall class impairment	Standard Deviation 8.819

Secondary

Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period

WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities (0-10 scale, high scores =less productivity). Percent overall class impairment due to health problem calculated as: 100\*{Q7/(Q7+Q8)+\[(1- Q7/(Q7+Q8))×(Q9/10)\]}, score range:0-100%,higher numbers=greater impairment and less productivity.

Time frame: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 16	2.50 Percent overall class impairment	Standard Deviation 5
Vehicle QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 32	0.00 Percent overall class impairment	Standard Deviation 0
Vehicle QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 4	6.95 Percent overall class impairment	Standard Deviation 14.568
Vehicle QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 20	0.00 Percent overall class impairment	—
Vehicle QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 40	5.00 Percent overall class impairment	Standard Deviation 7.071
Vehicle QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 12	5.00 Percent overall class impairment	Standard Deviation 10
Vehicle QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 44	20.00 Percent overall class impairment	—
Vehicle QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 24	10.00 Percent overall class impairment	Standard Deviation 14.142
Vehicle QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 48	7.50 Percent overall class impairment	Standard Deviation 15
Vehicle QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 8	1.43 Percent overall class impairment	Standard Deviation 3.78
Vehicle QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 52	0.00 Percent overall class impairment	Standard Deviation 0
Vehicle QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Baseline	8.64 Percent overall class impairment	Standard Deviation 14.136
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 44	10.00 Percent overall class impairment	Standard Deviation 10
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 48	5.56 Percent overall class impairment	Standard Deviation 11.304
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 52	3.33 Percent overall class impairment	Standard Deviation 7.071
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Baseline	10.10 Percent overall class impairment	Standard Deviation 13.237
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 4	7.50 Percent overall class impairment	Standard Deviation 12.701
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 8	7.40 Percent overall class impairment	Standard Deviation 9.858
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 12	5.59 Percent overall class impairment	Standard Deviation 13.91
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 16	14.37 Percent overall class impairment	Standard Deviation 25.677
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 20	14.29 Percent overall class impairment	Standard Deviation 29.921
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 24	3.50 Percent overall class impairment	Standard Deviation 7.283
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 28	10.00 Percent overall class impairment	Standard Deviation 14.142
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 32	12.39 Percent overall class impairment	Standard Deviation 21.847
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 36	5.00 Percent overall class impairment	Standard Deviation 7.071
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 40	6.25 Percent overall class impairment	Standard Deviation 9.161

Secondary

Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period

WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending (0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent overall class impairment due to health problem calculated as: 100\*{Q7/(Q7+Q8)+\[(1- Q7/(Q7+Q8))×(Q9/10)\]}, score range:0-100%, higher numbers=greater impairment and less productivity.

Time frame: Weeks 0, 4, 8 and 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 8	30.00 Percent overall class impairment	Standard Deviation 14.142
Vehicle QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 4	16.67 Percent overall class impairment	Standard Deviation 13.663
Vehicle QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 0	17.49 Percent overall class impairment	Standard Deviation 19.742
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 12	40.28 Percent overall class impairment	Standard Deviation 28.803
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 4	30.21 Percent overall class impairment	Standard Deviation 26.983
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 0	25.60 Percent overall class impairment	Standard Deviation 30.354
Crisaborole 2% QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 8	34.17 Percent overall class impairment	Standard Deviation 31.371

Secondary

Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period

WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past7days.Questions:Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked;Q5=degree health affected productivity while working (0-10 scale, high scores=less productivity);Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale, high scores= less productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity).Percent overall class impairment due to health problem calculated as: 100\*{Q7/(Q7+Q8)+\[(1- Q7/(Q7+Q8))×(Q9/10)\]},score range:0-100%,higher numbers=greater impairment and less productivity.

Time frame: Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period	Week 6	17.01 Percent overall class impairment	Standard Deviation 23.126
Vehicle QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period	Baseline	28.20 Percent overall class impairment	Standard Deviation 24.171
Vehicle QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period	Week 2	20.27 Percent overall class impairment	Standard Deviation 22.676
Vehicle QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period	Week 4	18.13 Percent overall class impairment	Standard Deviation 22.977
Vehicle QD	Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period	Week 8	16.20 Percent overall class impairment	Standard Deviation 22.148

Secondary

Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period

WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked;Q5=degree health affected productivity while working(0-10 scale, high scores=less productivity);Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale, high scores= less productivity);Q10=degree health affected productivity: regular daily activities(0-10 scale, high scores =less productivity). Percent overall impairment while working due to health problem calculated as:100\*{Q2/(Q2+Q4)+\[(1- Q2/(Q2+Q4))×(Q5/10)\]}, score ranged: 0-100%, high numbers=greater impairment and less productivity.

Time frame: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 20	15.15 Percent overall work impairment	Standard Deviation 17.456
Vehicle QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 4	10.20 Percent overall work impairment	Standard Deviation 17.73
Vehicle QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 40	11.01 Percent overall work impairment	Standard Deviation 12.629
Vehicle QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 24	8.33 Percent overall work impairment	Standard Deviation 8.906
Vehicle QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 48	10.36 Percent overall work impairment	Standard Deviation 10.518
Vehicle QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 36	14.50 Percent overall work impairment	Standard Deviation 14.186
Vehicle QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 28	12.32 Percent overall work impairment	Standard Deviation 12.997
Vehicle QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 12	10.11 Percent overall work impairment	Standard Deviation 16.906
Vehicle QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 32	12.69 Percent overall work impairment	Standard Deviation 16.267
Vehicle QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 52	17.91 Percent overall work impairment	Standard Deviation 21.428
Vehicle QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 44	21.93 Percent overall work impairment	Standard Deviation 32.299
Vehicle QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 16	21.06 Percent overall work impairment	Standard Deviation 24.41
Vehicle QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 8	11.46 Percent overall work impairment	Standard Deviation 14.98
Vehicle QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Baseline	14.04 Percent overall work impairment	Standard Deviation 19.991
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 40	11.33 Percent overall work impairment	Standard Deviation 21.941
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Baseline	14.29 Percent overall work impairment	Standard Deviation 21.183
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 4	15.53 Percent overall work impairment	Standard Deviation 20.088
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 8	8.29 Percent overall work impairment	Standard Deviation 16.813
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 12	9.13 Percent overall work impairment	Standard Deviation 23.216
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 16	7.17 Percent overall work impairment	Standard Deviation 19.121
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 20	3.67 Percent overall work impairment	Standard Deviation 5.715
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 24	15.35 Percent overall work impairment	Standard Deviation 25.202
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 28	0.82 Percent overall work impairment	Standard Deviation 1.834
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 32	11.35 Percent overall work impairment	Standard Deviation 20.568
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 36	10.76 Percent overall work impairment	Standard Deviation 10.143
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 44	12.37 Percent overall work impairment	Standard Deviation 23.664
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 48	20.64 Percent overall work impairment	Standard Deviation 28.599
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 52	14.68 Percent overall work impairment	Standard Deviation 23.128
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 36	5.73 Percent overall work impairment	Standard Deviation 11.45
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 20	19.00 Percent overall work impairment	Standard Deviation 23.558
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 16	17.50 Percent overall work impairment	Standard Deviation 24.349
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 40	6.67 Percent overall work impairment	Standard Deviation 11.547
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 12	14.04 Percent overall work impairment	Standard Deviation 19.828
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 4	15.80 Percent overall work impairment	Standard Deviation 25.411
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 44	7.08 Percent overall work impairment	Standard Deviation 9.463
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 8	10.73 Percent overall work impairment	Standard Deviation 16.268
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 28	9.25 Percent overall work impairment	Standard Deviation 12.738
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 52	10.00 Percent overall work impairment	Standard Deviation 10
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 32	18.27 Percent overall work impairment	Standard Deviation 31.639
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 24	22.76 Percent overall work impairment	Standard Deviation 35.623
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 48	20.55 Percent overall work impairment	Standard Deviation 22.249

Secondary

Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period

WPAI+CIQ: 10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending (0-10 scale, high scores = less productivity); Q10=degree health affected productivity: regular daily activities(0-10 scale, high scores =less productivity). Percent overall impairment while working due to health problem calculated as:100\*{Q2/(Q2+Q4)+\[(1- Q2/(Q2+Q4))×(Q5/10)\]}, score ranged:0-100%, high numbers=greater impairment and less productivity.

Time frame: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Baseline	14.04 Percent overall work impairment	Standard Deviation 19.991
Vehicle QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 4	10.74 Percent overall work impairment	Standard Deviation 18.593
Vehicle QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 8	11.77 Percent overall work impairment	Standard Deviation 16.662
Vehicle QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 12	11.43 Percent overall work impairment	Standard Deviation 21.931
Vehicle QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 16	17.57 Percent overall work impairment	Standard Deviation 23.791
Vehicle QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 20	15.00 Percent overall work impairment	Standard Deviation 21.213
Vehicle QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 24	8.86 Percent overall work impairment	Standard Deviation 9.442
Vehicle QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 28	10.00 Percent overall work impairment	Standard Deviation 14.142
Vehicle QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 32	18.92 Percent overall work impairment	Standard Deviation 20.929
Vehicle QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 36	10.00 Percent overall work impairment	Standard Deviation 14.142
Vehicle QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 40	13.40 Percent overall work impairment	Standard Deviation 11.616
Vehicle QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 44	30.00 Percent overall work impairment	Standard Deviation 43.589
Vehicle QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 48	12.86 Percent overall work impairment	Standard Deviation 11.127
Vehicle QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 52	15.83 Percent overall work impairment	Standard Deviation 20.595
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 40	15.82 Percent overall work impairment	Standard Deviation 26.16
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Baseline	14.29 Percent overall work impairment	Standard Deviation 21.183
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 28	2.05 Percent overall work impairment	Standard Deviation 2.899
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 4	15.53 Percent overall work impairment	Standard Deviation 20.088
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 48	23.46 Percent overall work impairment	Standard Deviation 29.836
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 8	10.06 Percent overall work impairment	Standard Deviation 18.129
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 32	18.29 Percent overall work impairment	Standard Deviation 24.749
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 12	13.70 Percent overall work impairment	Standard Deviation 27.729
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 44	24.73 Percent overall work impairment	Standard Deviation 30.679
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 16	10.75 Percent overall work impairment	Standard Deviation 22.825
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 36	11.27 Percent overall work impairment	Standard Deviation 10.238
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 20	7.33 Percent overall work impairment	Standard Deviation 6.429
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 52	17.20 Percent overall work impairment	Standard Deviation 25.996
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 24	19.63 Percent overall work impairment	Standard Deviation 29.412

Secondary

Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period

WPAI+CIQ: 10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working(0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending (0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent overall impairment while working due to health problem calculated as:100\*{Q2/(Q2+Q4)+\[(1- Q2/(Q2+Q4))×(Q5/10)\]}, score ranged:0-100%, high numbers=greater impairment and less productivity.

Time frame: Weeks 0, 4, 8 and 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 0	16.21 Percent overall work impairment	Standard Deviation 18.311
Vehicle QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 4	13.40 Percent overall work impairment	Standard Deviation 18.431
Vehicle QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 8	10.36 Percent overall work impairment	Standard Deviation 17.339
Vehicle QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 12	70.65 Percent overall work impairment	Standard Deviation 15.061
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 12	0.00 Percent overall work impairment	—
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 0	20.32 Percent overall work impairment	Standard Deviation 32.634
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 8	15.00 Percent overall work impairment	Standard Deviation 21.213
Crisaborole 2% QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 4	10.00 Percent overall work impairment	Standard Deviation 10

Secondary

Percent Overall Work Impairment Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period

WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days.Questions:Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked;Q5=degree health affected productivity while working(0-10 scale, high scores=less productivity);Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale, high scores= less productivity);Q10=degree health affected productivity: regular daily activities (0-10 scale, high scores =less productivity). Percent overall impairment while working due to health problem calculated as:100\*{Q2/(Q2+Q4)+\[(1- Q2/(Q2+Q4))×(Q5/10)\]},score ranged:0-100%,high numbers=greater impairment and less productivity.

Time frame: Weeks 0, 2, 4, 6 and 8

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period	Week 0	34.77 Percentage of work impairment	Standard Deviation 30.179
Vehicle QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period	Week 2	20.10 Percentage of work impairment	Standard Deviation 23.627
Vehicle QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period	Week 4	19.30 Percentage of work impairment	Standard Deviation 23.22
Vehicle QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period	Week 6	17.43 Percentage of work impairment	Standard Deviation 22.62
Vehicle QD	Percent Overall Work Impairment Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period	Week 8	19.36 Percentage of work impairment	Standard Deviation 24.564

Secondary

Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period

WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons;Q4=hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, high scores=less productivity);Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores=less productivity). Percent work time missed due to health problem calculated as: Q2\*100/(Q2+Q4) and score ranged from 0-100%,higher numbers=greater impairment and less productivity.

Time frame: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 20	4.34 Percent work time missed	Standard Deviation 9.633
Vehicle QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 4	5.67 Percent work time missed	Standard Deviation 14.861
Vehicle QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 40	1.91 Percent work time missed	Standard Deviation 6.181
Vehicle QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 24	0.37 Percent work time missed	Standard Deviation 0.997
Vehicle QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 48	1.44 Percent work time missed	Standard Deviation 3.746
Vehicle QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 36	5.00 Percent work time missed	Standard Deviation 11.18
Vehicle QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 28	0.36 Percent work time missed	Standard Deviation 0.805
Vehicle QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 12	3.98 Percent work time missed	Standard Deviation 13.835
Vehicle QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 32	5.55 Percent work time missed	Standard Deviation 14.5
Vehicle QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 52	11.27 Percent work time missed	Standard Deviation 20.344
Vehicle QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 44	0.27 Percent work time missed	Standard Deviation 0.653
Vehicle QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 16	14.84 Percent work time missed	Standard Deviation 30.656
Vehicle QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 8	5.48 Percent work time missed	Standard Deviation 14.237
Vehicle QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Baseline	4.77 Percent work time missed	Standard Deviation 14.528
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 40	3.02 Percent work time missed	Standard Deviation 11.77
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Baseline	5.07 Percent work time missed	Standard Deviation 14.128
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 4	5.54 Percent work time missed	Standard Deviation 15.12
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 8	2.99 Percent work time missed	Standard Deviation 12.345
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 12	3.85 Percent work time missed	Standard Deviation 12.97
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 16	3.55 Percent work time missed	Standard Deviation 10.903
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 20	0.37 Percent work time missed	Standard Deviation 0.898
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 24	7.24 Percent work time missed	Standard Deviation 17.75
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 28	0.82 Percent work time missed	Standard Deviation 1.834
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 32	9.22 Percent work time missed	Standard Deviation 25.636
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 36	0.84 Percent work time missed	Standard Deviation 1.878
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 44	0.70 Percent work time missed	Standard Deviation 1.715
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 48	11.51 Percent work time missed	Standard Deviation 21.033
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 52	5.00 Percent work time missed	Standard Deviation 12.884
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 36	3.58 Percent work time missed	Standard Deviation 7.15
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 20	10.00 Percent work time missed	Standard Deviation 22.361
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 16	6.25 Percent work time missed	Standard Deviation 17.678
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 40	0.00 Percent work time missed	Standard Deviation 0
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 12	6.81 Percent work time missed	Standard Deviation 16.477
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 4	2.80 Percent work time missed	Standard Deviation 10.617
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 44	2.08 Percent work time missed	Standard Deviation 4.15
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 8	1.41 Percent work time missed	Standard Deviation 3.066
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 28	4.73 Percent work time missed	Standard Deviation 9.45
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 52	0.00 Percent work time missed	Standard Deviation 0
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 32	18.27 Percent work time missed	Standard Deviation 31.639
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 24	18.76 Percent work time missed	Standard Deviation 29.995
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	Week 48	5.55 Percent work time missed	Standard Deviation 13.595

Secondary

Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period

WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were: Q1=currently employed; Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5= degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent work time missed due to health problem calculated as: Q2\*100/(Q2+Q4) and score ranged from 0-100%, higher numbers=greater impairment and less productivity.

Time frame: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Baseline	4.77 Percent work time missed	Standard Deviation 14.528
Vehicle QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 4	5.76 Percent work time missed	Standard Deviation 15.662
Vehicle QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 8	7.50 Percent work time missed	Standard Deviation 16.965
Vehicle QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 12	7.14 Percent work time missed	Standard Deviation 18.898
Vehicle QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 16	23.49 Percent work time missed	Standard Deviation 38.319
Vehicle QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 20	0.00 Percent work time missed	Standard Deviation 0
Vehicle QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 24	0.34 Percent work time missed	Standard Deviation 0.907
Vehicle QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 28	0.00 Percent work time missed	Standard Deviation 0
Vehicle QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 32	11.75 Percent work time missed	Standard Deviation 20.454
Vehicle QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 36	0.00 Percent work time missed	Standard Deviation 0
Vehicle QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 40	0.69 Percent work time missed	Standard Deviation 1.814
Vehicle QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 44	0.00 Percent work time missed	Standard Deviation 0
Vehicle QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 48	1.79 Percent work time missed	Standard Deviation 4.725
Vehicle QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 52	8.33 Percent work time missed	Standard Deviation 20.412
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 40	4.95 Percent work time missed	Standard Deviation 15.001
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Baseline	5.07 Percent work time missed	Standard Deviation 14.128
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 28	2.05 Percent work time missed	Standard Deviation 2.899
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 4	5.54 Percent work time missed	Standard Deviation 15.12
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 48	12.27 Percent work time missed	Standard Deviation 21.541
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 8	3.64 Percent work time missed	Standard Deviation 13.604
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 32	15.08 Percent work time missed	Standard Deviation 31.936
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 12	5.77 Percent work time missed	Standard Deviation 15.79
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 44	1.40 Percent work time missed	Standard Deviation 2.425
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 16	5.32 Percent work time missed	Standard Deviation 13.142
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 36	1.40 Percent work time missed	Standard Deviation 2.425
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 20	0.73 Percent work time missed	Standard Deviation 1.27
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 52	3.33 Percent work time missed	Standard Deviation 6.022
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	Week 24	8.03 Percent work time missed	Standard Deviation 18.722

Secondary

Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period

WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending (0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities (0-10 scale, high scores=less productivity). Percent work time missed due to health problem calculated as: Q2\*100/(Q2+Q4) and score ranged from 0-100%, higher numbers=greater impairment and less productivity.

Time frame: Weeks 0, 4, 8 and 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 8	2.36 Percent work time missed	Standard Deviation 5.277
Vehicle QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 12	34.40 Percent work time missed	Standard Deviation 48.649
Vehicle QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 0	5.46 Percent work time missed	Standard Deviation 14.226
Vehicle QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 4	1.49 Percent work time missed	Standard Deviation 3.188
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 4	0.00 Percent work time missed	Standard Deviation 0
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 8	0.00 Percent work time missed	Standard Deviation 0
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 0	6.99 Percent work time missed	Standard Deviation 18.46
Crisaborole 2% QD	Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	Week 12	0.00 Percent work time missed	—

Secondary

Percent Work Time Missed Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period

WPAI plus CIQ was a 10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were: Q1= currently employed; Q2= work hours missed due to health problems; Q3= work hours missed due to other reasons; Q4= hours actually worked; Q5= degree health affected productivity while working (0-10 scale, higher scores = less productivity); Q6= classes attended in academic setting or not; Q7= class hours missed due to health problems; Q8= class hours actually attended; Q9= degree health affected productivity while attending (0-10 scale, high scores= less productivity); Q10= degree health affected productivity in regular daily activities (0-10 scale, higher scores = less productivity). Percent work time missed was calculated as: Q2\*100/(Q2+Q4) and score ranged from 0-100%, higher scores = greater impairment and less productivity.

Time frame: Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Percent Work Time Missed Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period	Baseline	5.75 Percentage of work time missed	Standard Deviation 16.796
Vehicle QD	Percent Work Time Missed Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period	Week 2	4.72 Percentage of work time missed	Standard Deviation 15.553
Vehicle QD	Percent Work Time Missed Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period	Week 4	5.92 Percentage of work time missed	Standard Deviation 16.487
Vehicle QD	Percent Work Time Missed Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period	Week 6	4.83 Percentage of work time missed	Standard Deviation 14.801
Vehicle QD	Percent Work Time Missed Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period	Week 8	6.96 Percentage of work time missed	Standard Deviation 18.08

Secondary

Secondary: Duration of Pruritus Response Maintenance Until Onset of First Flare During the DB Period: Participants Aged >=12 Years With Baseline Peak Pruritus Numerical Rating Scale (PP NRS) >=3, >=4 and >=3, >=4 Points Reduction in PP NRS

Duration of pruritus response maintenance=time from randomization to loss of pruritus response or first flare onset(ISGA\>=2) during 52-week DB period evaluated among pruritus responders at randomization. Responders=participants with success in ISGA and EASI50 criteria. Pruritus response maintenance=maintenance of \>=50% improvement in pruritus from baseline obtained at randomization. If event (e.g., death, first flare\[ISGA \>=2\], lost to follow up or end of study) occurred before loss of pruritus response for first flare-free period, duration of pruritus response maintenance was time from randomization to last assessment and was censored. Here,pruritus response maintenance duration was presented for participants aged \>=12 years with OL baseline PP NRS \>=3, \>=4 and \>=3, \>=4 points reduction from OL baseline to randomization in PP NRS. PP NRS: Participants were asked to rate their itch at worst moment during previous 24 hours on a scale of 0 to 10; 0=no itch and 10=worst itch imaginable.

Time frame: From randomization up to loss of pruritus response or onset of first flare or the last assessment (maximum of 52 weeks)

Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, 'Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and Number Analyzed'' signifies participants evaluable for specified rows.

Arm	Measure	Group	Value (MEDIAN)
Vehicle QD	Secondary: Duration of Pruritus Response Maintenance Until Onset of First Flare During the DB Period: Participants Aged >=12 Years With Baseline Peak Pruritus Numerical Rating Scale (PP NRS) >=3, >=4 and >=3, >=4 Points Reduction in PP NRS	Baseline PP NRS >=3 and >=3 point reduction in PP NRS	NA Days
Vehicle QD	Secondary: Duration of Pruritus Response Maintenance Until Onset of First Flare During the DB Period: Participants Aged >=12 Years With Baseline Peak Pruritus Numerical Rating Scale (PP NRS) >=3, >=4 and >=3, >=4 Points Reduction in PP NRS	Baseline PP NRS >=4 and >=4 point reduction in PP NRS	NA Days
Crisaborole 2% QD	Secondary: Duration of Pruritus Response Maintenance Until Onset of First Flare During the DB Period: Participants Aged >=12 Years With Baseline Peak Pruritus Numerical Rating Scale (PP NRS) >=3, >=4 and >=3, >=4 Points Reduction in PP NRS	Baseline PP NRS >=3 and >=3 point reduction in PP NRS	164 Days
Crisaborole 2% QD	Secondary: Duration of Pruritus Response Maintenance Until Onset of First Flare During the DB Period: Participants Aged >=12 Years With Baseline Peak Pruritus Numerical Rating Scale (PP NRS) >=3, >=4 and >=3, >=4 Points Reduction in PP NRS	Baseline PP NRS >=4 and >=4 point reduction in PP NRS	309 Days

Comparison: Baseline PP NRS \>=3 and \>=3 point reduction in PP NRSp-value: 0.6815Log Rank

Comparison: Baseline PP NRS \>=4 and \>=4 point reduction in PP NRSp-value: 0.1518Log Rank

Secondary

Secondary: Duration of Pruritus Response Maintenance Until Onset of First Flare During the DB Period: Participants Aged 6 to <12 Years With Baseline Patient Reported Itch Severity (PRIS) >=2 and >=2 Points Reduction in PRIS

Duration of pruritus response maintenance=time from randomization to loss of pruritus response or first flare onset (ISGA\>=2) during 52-week DB period. Evaluated among pruritus responders at randomization. Responders were defined as participants with success in ISGA and EASI50 criteria. Pruritus response maintenance=maintenance of \>=50% improvement in pruritus from baseline that was obtained at randomization. If an event (e.g., death, first flare \[ISGA \>=2\], lost to follow up, or end of study) occurred before loss of pruritus response for first flare-free period, duration of maintenance of pruritus response was time from randomization to last assessment and was censored. Here, pruritus response maintenance duration was presented for participants aged 6 to \<12 years with baseline PRIS \>=2 and \>=2 points reduction from baseline to randomization in PRIS. PRIS: a 5-point scale (range: 0=no itch to 4=worst itch imaginable) and was completed by participants.

Time frame: From randomization up to loss of pruritus response or onset of first flare or the last assessment (maximum of 52 weeks)

Arm	Measure	Value (MEDIAN)
Vehicle QD	Secondary: Duration of Pruritus Response Maintenance Until Onset of First Flare During the DB Period: Participants Aged 6 to <12 Years With Baseline Patient Reported Itch Severity (PRIS) >=2 and >=2 Points Reduction in PRIS	NA Days
Crisaborole 2% QD	Secondary: Duration of Pruritus Response Maintenance Until Onset of First Flare During the DB Period: Participants Aged 6 to <12 Years With Baseline Patient Reported Itch Severity (PRIS) >=2 and >=2 Points Reduction in PRIS	133 Days

p-value: 0.1933Log Rank

Secondary

Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period

HADS was a validated 14-item questionnaire to assess states of anxiety and depression over the past week. HADS consisted of 2 subscales: HADS-A and HADS-D, each of which comprised of 7 items. Each item was rated on a 4-point scale, with scores ranging from 0 to 3, where higher scores indicated more anxiety/depression symptoms. HADS-A assessed state of generalized anxiety. HADS-A total score = sum of all 7 items with score ranging from 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicated greater severity of anxiety. HADS-D assessed the state of lost interest and diminished pleasure response. HADS-D total score = sum of all 7 items with score ranging from 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicated greater severity of depression symptoms.

Time frame: Baseline (last observation up to and including randomization day), Week 8, 16, 32 and end of treatment [Week 52]

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period	Anxiety: Baseline	4.5 Units on a scale	Standard Deviation 3.5
Vehicle QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period	Anxiety: Week 8	3.6 Units on a scale	Standard Deviation 3.23
Vehicle QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period	Anxiety: Week 16	4.6 Units on a scale	Standard Deviation 3.83
Vehicle QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period	Anxiety: Week 32	3.3 Units on a scale	Standard Deviation 3.42
Vehicle QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period	Anxiety: End of treatment	4.0 Units on a scale	Standard Deviation 3.95
Vehicle QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period	Depression: Baseline	2.7 Units on a scale	Standard Deviation 2.36
Vehicle QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period	Depression: Week 8	2.1 Units on a scale	Standard Deviation 2
Vehicle QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period	Depression: Week 16	2.9 Units on a scale	Standard Deviation 2.65
Vehicle QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period	Depression: Week 32	2.6 Units on a scale	Standard Deviation 2.82
Vehicle QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period	Depression: End of treatment	2.8 Units on a scale	Standard Deviation 2.77
Crisaborole 2% QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period	Anxiety: Week 32	4.4 Units on a scale	Standard Deviation 4
Crisaborole 2% QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period	Depression: End of treatment	3.4 Units on a scale	Standard Deviation 3.23
Crisaborole 2% QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period	Anxiety: End of treatment	4.7 Units on a scale	Standard Deviation 3.62
Crisaborole 2% QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period	Depression: Week 32	3.3 Units on a scale	Standard Deviation 3.76
Crisaborole 2% QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period	Depression: Baseline	2.8 Units on a scale	Standard Deviation 2.94
Crisaborole 2% QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period	Depression: Week 8	2.5 Units on a scale	Standard Deviation 2.65
Crisaborole 2% QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period	Anxiety: Baseline	4.5 Units on a scale	Standard Deviation 3.59
Crisaborole 2% QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period	Anxiety: Week 8	4.5 Units on a scale	Standard Deviation 3.09
Crisaborole 2% QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period	Depression: Week 16	3.5 Units on a scale	Standard Deviation 3.76
Crisaborole 2% QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period	Anxiety: Week 16	4.7 Units on a scale	Standard Deviation 3.58
Crisaborole 2% QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period	Depression: End of treatment	2.6 Units on a scale	Standard Deviation 2.91
Crisaborole 2% QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period	Anxiety: End of treatment	4.7 Units on a scale	Standard Deviation 2.91
Crisaborole 2% QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period	Anxiety: Week 16	3.0 Units on a scale	Standard Deviation 2.65
Crisaborole 2% QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period	Anxiety: Week 8	3.8 Units on a scale	Standard Deviation 2.71
Crisaborole 2% QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period	Depression: Week 32	3.5 Units on a scale	Standard Deviation 3.54
Crisaborole 2% QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period	Depression: Week 16	1.3 Units on a scale	Standard Deviation 1.53
Crisaborole 2% QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period	Depression: Week 8	2.2 Units on a scale	Standard Deviation 1.72
Crisaborole 2% QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period	Anxiety: Week 32	4.0 Units on a scale	Standard Deviation 5.66

Secondary

Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Free Period

Time frame: Baseline (last observation up to and including the randomization day of DB period), Weeks 8, 16 and 32

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Free Period	Anxiety: Baseline	4.5 Units on a scale	Standard Deviation 3.5
Vehicle QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Free Period	Anxiety: Week 8	3.8 Units on a scale	Standard Deviation 3.28
Vehicle QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Free Period	Anxiety: Week 16	3.9 Units on a scale	Standard Deviation 3.38
Vehicle QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Free Period	Anxiety: Week 32	2.9 Units on a scale	Standard Deviation 2.47
Vehicle QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Free Period	Depression: Baseline	2.7 Units on a scale	Standard Deviation 2.36
Vehicle QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Free Period	Depression: Week 8	2.2 Units on a scale	Standard Deviation 2.13
Vehicle QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Free Period	Depression: Week 16	2.1 Units on a scale	Standard Deviation 1.91
Vehicle QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Free Period	Depression: Week 32	1.9 Units on a scale	Standard Deviation 2.22
Crisaborole 2% QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Free Period	Depression: Week 32	3.0 Units on a scale	Standard Deviation 3
Crisaborole 2% QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Free Period	Anxiety: Baseline	4.5 Units on a scale	Standard Deviation 3.59
Crisaborole 2% QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Free Period	Depression: Baseline	2.8 Units on a scale	Standard Deviation 2.94
Crisaborole 2% QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Free Period	Anxiety: Week 8	4.1 Units on a scale	Standard Deviation 2.74
Crisaborole 2% QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Free Period	Depression: Week 16	3.1 Units on a scale	Standard Deviation 3.46
Crisaborole 2% QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Free Period	Anxiety: Week 16	4.3 Units on a scale	Standard Deviation 3.49
Crisaborole 2% QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Free Period	Depression: Week 8	2.2 Units on a scale	Standard Deviation 2.29
Crisaborole 2% QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Free Period	Anxiety: Week 32	4.2 Units on a scale	Standard Deviation 3.79

Secondary

Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Period

Time frame: Weeks 0, 4, 8 and 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Period	Anxiety: Week 0	3.7 Units on a scale	Standard Deviation 3.52
Vehicle QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Period	Anxiety: Week 4	4.3 Units on a scale	Standard Deviation 3.46
Vehicle QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Period	Anxiety: Week 8	4.3 Units on a scale	Standard Deviation 1.89
Vehicle QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Period	Anxiety: Week 12	6.0 Units on a scale	Standard Deviation 1
Vehicle QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Period	Depression: Week 0	2.4 Units on a scale	Standard Deviation 3.07
Vehicle QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Period	Depression: Week 4	3.1 Units on a scale	Standard Deviation 2.79
Vehicle QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Period	Depression: Week 8	1.3 Units on a scale	Standard Deviation 1.26
Vehicle QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Period	Depression: Week 12	1.0 Units on a scale	Standard Deviation 1
Crisaborole 2% QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Period	Depression: Week 12	3.3 Units on a scale	Standard Deviation 2.16
Crisaborole 2% QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Period	Anxiety: Week 0	4.9 Units on a scale	Standard Deviation 3.7
Crisaborole 2% QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Period	Depression: Week 0	2.5 Units on a scale	Standard Deviation 3.16
Crisaborole 2% QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Period	Anxiety: Week 4	5.8 Units on a scale	Standard Deviation 4.19
Crisaborole 2% QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Period	Depression: Week 8	4.8 Units on a scale	Standard Deviation 4.44
Crisaborole 2% QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Period	Anxiety: Week 8	8.0 Units on a scale	Standard Deviation 5.24
Crisaborole 2% QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Period	Depression: Week 4	4.2 Units on a scale	Standard Deviation 5.19
Crisaborole 2% QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Period	Anxiety: Week 12	5.0 Units on a scale	Standard Deviation 4.73

Secondary

Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale (HADS): OL Run-in Period

HADS was a validated 14-item questionnaire to assess states of anxiety and depression over the past week. HADS consisted of 2 subscales: HADS-anxiety (HADS-A) and HADS-depression (HADS-D), each of which comprised of 7 items. Each item was rated on a 4-point scale, with scores ranging from 0 to 3, where higher scores indicated more anxiety/depression symptoms. HADS-A assessed state of generalized anxiety. HADS-A total score = sum of all 7 items with score ranging from 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicated greater severity of anxiety. HADS-D assessed the state of lost interest and diminished pleasure response. HADS-D total score = sum of all 7 items with score ranging from 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicated greater severity of depression symptoms.

Time frame: Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale (HADS): OL Run-in Period	Anxiety: Baseline	5.3 Units on a scale	Standard Deviation 3.7
Vehicle QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale (HADS): OL Run-in Period	Anxiety: Week 2	5.3 Units on a scale	Standard Deviation 3.73
Vehicle QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale (HADS): OL Run-in Period	Anxiety: Week 4	5.3 Units on a scale	Standard Deviation 3.72
Vehicle QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale (HADS): OL Run-in Period	Anxiety: Week 6	5.4 Units on a scale	Standard Deviation 3.79
Vehicle QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale (HADS): OL Run-in Period	Anxiety: Week 8	5.4 Units on a scale	Standard Deviation 3.81
Vehicle QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale (HADS): OL Run-in Period	Depression: Baseline	3.2 Units on a scale	Standard Deviation 3.09
Vehicle QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale (HADS): OL Run-in Period	Depression: Week 2	3.2 Units on a scale	Standard Deviation 3.09
Vehicle QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale (HADS): OL Run-in Period	Depression: Week 4	3.2 Units on a scale	Standard Deviation 3.11
Vehicle QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale (HADS): OL Run-in Period	Depression: Week 6	3.3 Units on a scale	Standard Deviation 3.16
Vehicle QD	Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale (HADS): OL Run-in Period	Depression: Week 8	3.3 Units on a scale	Standard Deviation 3.21

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026

A Study to Evaluate Long-Term Maintenance Treatment With Once Daily Crisaborole Ointment 2% in Pediatric and Adult Participants With Mild-to-Moderate Atopic Dermatitis

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Duration of Flare-Free Maintenance Until Onset of First-Flare During the Double Blind (DB) Period

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

AD Skin Pain Scores for Participants >=12 Years of Age: DB Period

AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period

AD Skin Pain Scores for Participants >=12 Years of Age: First Flare Period

AD Skin Pain Scores for Participants >=12 Years of Age: OL Run-in Period

Change From Baseline in ISGA Scores at Weeks 0, 4, 8 and 12 for First Flare Treatment Period

Change From Baseline in ISGA Scores at Weeks 2, 4, 6 and 8 for OL run-in Period

Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period

Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period

Change From Baseline in Most Commonly Affected Atopic Dermatitis (AD) % BSA: DB Period

Change From Baseline in Treatable %BSA: DB Period

Change From Baseline in Treatable %BSA: First Flare Free Period

Change From Baseline in Treatable %BSA: First Flare Period

Change From Baseline in Treatable Percent Body Surface Area (% BSA): OL Run-in Period

Duration (Days) of Flare Period

Duration of Maintenance of >=50% Reduction in Eczema Area and Severity Index (EASI) Total Score Until Onset of First Flare During the DB Period

Duration of Maintenance of Dermatology Life Quality Index (DLQI) Response Until Onset of First Flare During the DB Period

Duration of Maintenance of Patient Oriented Eczema Measure (POEM) Response Until Onset of First Flare During the DB Period

Duration of Pruritus Response Maintenance Until Onset of First Flare During the DB Period: Observer Reported Itch Severity Scale (ORIS) in Participants Aged 3 to <6 Months

EASI Score for the First Flare Period

European Quality of Life-5 Dimension 5-Level (EQ-5D-5L) Index Score in Participants Greater Than or Equal to (>=) 18 Years of Age: OL Run-in Period

European Quality of Life-5 Dimension Youth (EuroQoL EQ-5D Y) Index Score in Participants Between 8-17 Years of Age: OL Run-in Period

EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period

EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: First Flare Period

EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period

EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period

EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Period

EuroQoL EQ-5D-5L Visual Analog Scale (VAS) Score in Participants >= 18 Years of Age: OL Run-in Period

EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period

EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period

EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period

EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Period

EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period

EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period

EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Period

EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: OL Run-in Period

EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period

EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period

EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Period

EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: OL Run-in Period

EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period

EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period

EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Period

EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age : OL-Run-in Period

Investigator's Static Global Assessment (ISGA) Score for the First Flare Period

Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period

Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period

Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period

Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period

Night Time Itch Score for Participants >=12 Years of Age: DB Period

Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period

Night Time Itch Score for Participants >=12 Years of Age: First Flare Period

Night Time Itch Score for Participants >=12 Years of Age: OL Run-in Period

Number of Flare-Free Days During the DB Period

Number of Flares During the DB Period

Patient/Observer Global Impression of Change Score: DB Period