Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:55 PM
Study NCT ID:
NCT03954158
Status:
COMPLETED
Last Update Posted:
2020-07-14
First Post:
2019-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Assess Efficacy and Safety of Two Regimens of Crisaborole Ointment 2% in Japanese Participants Aged ≥2 Years With Mild to Moderate Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 up to 35 days after end of treatment (maximum up to Day 50)', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1: Crisaborole 2% QD + Vehicle QD, Age Group >=12 Years', 'description': 'Participants in this reporting arm were of age \\>=12 years. Investigator determined 2 target lesions of same AD severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied QD to 1 of the target lesions and vehicle was applied QD to another target lesion (intra-participant) for 15 days and participants were followed up to maximum of 35 days after the end of treatment (maximum up to Day 50).', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 6, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort 1:Crisaborole 2% BID + Vehicle BID,Age Group >=12 Years', 'description': 'Participants in this reporting arm were of age \\>=12 years. Investigator determined 2 target lesions of same AD severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied BID to 1 of the target lesions and vehicle was applied BID to another target lesion (intra-participant) for 15 days and participants were followed up to maximum of 35 days after the end of treatment (maximum up to Day 50).', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 6, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort 2:Crisaborole 2% QD + Vehicle QD, Age Group 2-11 Years', 'description': 'Participants in this reporting arm were of age 2 to 11 years. Investigator determined 2 target lesions of same AD severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied QD to 1 of the target lesions and vehicle was applied QD to another target lesion (intra-participant) for 15 days and participants were followed up to maximum of 35 days after the end of treatment (maximum up to Day 50).', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 2, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cohort 2:Crisaborole 2% BID + Vehicle BID,Age Group 2-11 Years', 'description': 'Participants in this reporting arm were of age 2 to 11 years. Investigator determined 2 target lesions of same AD severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied BID to 1 of the target lesions and vehicle was applied BID to another target lesion (intra-participant) for 15 days and participants were followed up to maximum of 35 days after the end of treatment (maximum up to Day 50).', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 2, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Application site coldness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Application site irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Application site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Application site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Application site folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hand-foot-and-mouth disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Total Sign Score (TSS) in Target Lesions at Day 15: Crisaborole Ointment 2% Versus Vehicle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Crisaborole 2% QD: Age Group >=12 Years', 'description': 'Participants in this reporting arm were of age \\>=12 years. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied QD to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG001', 'title': 'Vehicle QD: Age Group >=12 Years', 'description': 'Participants in this reporting arm were of age \\>=12 years. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Vehicle was applied QD to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG002', 'title': 'Crisaborole 2% BID: Age Group >=12 Years', 'description': 'Participants in this reporting arm were of age \\>=12 years. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied BID to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG003', 'title': 'Vehicle BID: Age Group >=12 Years', 'description': 'Participants in this reporting arm were of age \\>=12 years. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Vehicle was applied BID to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG004', 'title': 'Crisaborole 2% QD: Age Group 2 to 11 Years', 'description': 'Participants in this reporting arm were of age 2 to 11. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied QD to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG005', 'title': 'Vehicle QD: Age Group 2 to 11 Years', 'description': 'Participants in this reporting arm were of age 2 to 11. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Vehicle was applied QD to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG006', 'title': 'Crisaborole 2% BID: Age Group 2 to 11 Years', 'description': 'Participants in this reporting arm were of age 2 to 11. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied BID to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG007', 'title': 'Vehicle BID: Age Group 2 to 11 Years', 'description': 'Participants in this reporting arm were of age 2 to 11. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Vehicle was applied BID to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.7', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '0.45', 'groupId': 'OG001'}, {'value': '7.1', 'spread': '0.46', 'groupId': 'OG002'}, {'value': '7.4', 'spread': '0.48', 'groupId': 'OG003'}, {'value': '6.2', 'spread': '0.38', 'groupId': 'OG004'}, {'value': '6.5', 'spread': '0.37', 'groupId': 'OG005'}, {'value': '7.1', 'spread': '0.45', 'groupId': 'OG006'}, {'value': '7.3', 'spread': '0.44', 'groupId': 'OG007'}]}]}, {'title': 'Change at Day 15', 'categories': [{'measurements': [{'value': '-4.5', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '0.51', 'groupId': 'OG001'}, {'value': '-4.8', 'spread': '0.53', 'groupId': 'OG002'}, {'value': '-2.7', 'spread': '0.47', 'groupId': 'OG003'}, {'value': '-3.5', 'spread': '0.47', 'groupId': 'OG004'}, {'value': '-2.0', 'spread': '0.50', 'groupId': 'OG005'}, {'value': '-4.7', 'spread': '0.50', 'groupId': 'OG006'}, {'value': '-2.6', 'spread': '0.54', 'groupId': 'OG007'}]}]}], 'analyses': [{'pValue': '0.0071', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '-0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.53', 'groupDescription': 'Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures (MMRM) included the fixed effect of visit, and the covariance structure UN was used.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0029', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.0', 'ciLowerLimit': '-3.3', 'ciUpperLimit': '-0.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.60', 'groupDescription': 'Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of visit, and the covariance structure UN was used.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0250', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '-0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.60', 'groupDescription': 'Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of visit, and the covariance structure UN was used.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0014', 'groupIds': ['OG006', 'OG007'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.1', 'ciLowerLimit': '-3.3', 'ciUpperLimit': '-0.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.56', 'groupDescription': 'Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of visit, and the covariance structure UN was used.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 15', 'description': 'Lesion TSS was an assessment of the target lesion severity, which was based on severity of 4 clinical signs erythema, induration/papulation, excoriation and lichenification. All of these 4 signs were rated on a scale of 0 to 3 (0= none, 1= mild, 2= moderate, 3= severe). These ratings were added to create a total TSS score; ranging from 0 (none) to 12 (most severe), with higher score representing greater severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized and received greater than or equal to 1 dose of investigational product.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Sign Score in Target Lesions at Day 15: Crisaborole Ointment 2% BID Versus Crisaborole Ointment 2% QD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Crisaborole 2% QD: Age Group >=12 Years', 'description': 'Participants in this reporting arm were of age \\>=12 years. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied QD to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG001', 'title': 'Crisaborole 2% BID: Age Group >=12 Years', 'description': 'Participants in this reporting arm were of age \\>=12 years. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied BID to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG002', 'title': 'Crisaborole 2% QD: Age Group 2 to 11 Years', 'description': 'Participants in this reporting arm were of age 2 to 11. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied QD to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG003', 'title': 'Crisaborole 2% BID: Age Group 2 to 11 Years', 'description': 'Participants in this reporting arm were of age 2 to 11. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied BID to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.3', 'groupId': 'OG000', 'lowerLimit': '-5.4', 'upperLimit': '-3.3'}, {'value': '-4.9', 'groupId': 'OG001', 'lowerLimit': '-5.9', 'upperLimit': '-3.9'}, {'value': '-3.7', 'groupId': 'OG002', 'lowerLimit': '-4.5', 'upperLimit': '-2.8'}, {'value': '-4.5', 'groupId': 'OG003', 'lowerLimit': '-5.4', 'upperLimit': '-3.6'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '0.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.4295', 'groupDescription': 'Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference of least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.61', 'groupDescription': 'Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 15', 'description': 'Lesion TSS was an assessment of the target lesion severity, which was based on severity of 4 clinical signs erythema, induration/papulation, excoriation and lichenification. All of these 4 signs were rated on a scale of 0 to 3 (0= none, 1= mild, 2= moderate, 3= severe). These ratings were added to create a total TSS score; ranging from 0 (none) to 12 (most severe), with higher score representing greater severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized and received greater than or equal to 1 dose of investigational product.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Sign Score in Target Lesions at Day 8: Crisaborole Ointment 2% Versus Vehicle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Crisaborole 2% QD: Age Group >=12 Years', 'description': 'Participants in this reporting arm were of age \\>=12 years. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied QD to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG001', 'title': 'Vehicle QD: Age Group >=12 Years', 'description': 'Participants in this reporting arm were of age \\>=12 years. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Vehicle was applied QD to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG002', 'title': 'Crisaborole 2% BID: Age Group >=12 Years', 'description': 'Participants in this reporting arm were of age \\>=12 years. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied BID to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG003', 'title': 'Vehicle BID: Age Group >=12 Years', 'description': 'Participants in this reporting arm were of age \\>=12 years. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Vehicle was applied BID to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG004', 'title': 'Crisaborole 2% QD: Age Group 2 to 11 Years', 'description': 'Participants in this reporting arm were of age 2 to 11. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied QD to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG005', 'title': 'Vehicle QD: Age Group 2 to 11 Years', 'description': 'Participants in this reporting arm were of age 2 to 11. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Vehicle was applied QD to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG006', 'title': 'Crisaborole 2% BID: Age Group 2 to 11 Years', 'description': 'Participants in this reporting arm were of age 2 to 11. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied BID to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG007', 'title': 'Vehicle BID: Age Group 2 to 11 Years', 'description': 'Participants in this reporting arm were of age 2 to 11. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Vehicle was applied BID to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '7.7', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '0.45', 'groupId': 'OG001'}, {'value': '7.1', 'spread': '0.46', 'groupId': 'OG002'}, {'value': '7.4', 'spread': '0.48', 'groupId': 'OG003'}, {'value': '6.2', 'spread': '0.38', 'groupId': 'OG004'}, {'value': '6.5', 'spread': '0.37', 'groupId': 'OG005'}, {'value': '7.1', 'spread': '0.45', 'groupId': 'OG006'}, {'value': '7.3', 'spread': '0.44', 'groupId': 'OG007'}]}]}, {'title': 'Change at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-3.9', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '0.40', 'groupId': 'OG001'}, {'value': '-3.7', 'spread': '0.53', 'groupId': 'OG002'}, {'value': '-2.3', 'spread': '0.35', 'groupId': 'OG003'}, {'value': '-3.2', 'spread': '0.34', 'groupId': 'OG004'}, {'value': '-1.9', 'spread': '0.40', 'groupId': 'OG005'}, {'value': '-3.7', 'spread': '0.46', 'groupId': 'OG006'}, {'value': '-2.0', 'spread': '0.39', 'groupId': 'OG007'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.9', 'ciLowerLimit': '-3.1', 'ciUpperLimit': '-0.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.56', 'groupDescription': 'Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '-0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.60', 'groupDescription': 'Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '-0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.49', 'groupDescription': 'Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.7', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '-0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.55', 'groupDescription': 'Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least square mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '1.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.69', 'groupDescription': 'Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG004', 'OG006'], 'paramType': 'Difference of least square mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '1.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.54', 'groupDescription': 'Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 8', 'description': 'Lesion TSS was an assessment of the target lesion severity, which was based on severity of 4 clinical signs erythema, induration/papulation, excoriation and lichenification. All of these 4 signs were rated on a scale of 0 to 3 (0= none, 1= mild, 2= moderate, 3= severe). These ratings were added to create a total TSS score; ranging from 0 (none) to 12 (most severe), with higher score representing greater severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized and received greater than or equal to 1 dose of investigational product. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Investigator's Static Global Assessment (ISGA) Score in Target Lesions at Day 8 and Day 15", 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Crisaborole 2% QD: Age Group >=12 Years', 'description': 'Participants in this reporting arm were of age \\>=12 years. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied QD to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG001', 'title': 'Vehicle QD: Age Group >=12 Years', 'description': 'Participants in this reporting arm were of age \\>=12 years. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Vehicle was applied QD to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG002', 'title': 'Crisaborole 2% BID: Age Group >=12 Years', 'description': 'Participants in this reporting arm were of age \\>=12 years. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied BID to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG003', 'title': 'Vehicle BID: Age Group >=12 Years', 'description': 'Participants in this reporting arm were of age \\>=12 years. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Vehicle was applied BID to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG004', 'title': 'Crisaborole 2% QD: Age Group 2 to 11 Years', 'description': 'Participants in this reporting arm were of age 2 to 11. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied QD to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG005', 'title': 'Vehicle QD: Age Group 2 to 11 Years', 'description': 'Participants in this reporting arm were of age 2 to 11. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Vehicle was applied QD to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG006', 'title': 'Crisaborole 2% BID: Age Group 2 to 11 Years', 'description': 'Participants in this reporting arm were of age 2 to 11. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied BID to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG007', 'title': 'Vehicle BID: Age Group 2 to 11 Years', 'description': 'Participants in this reporting arm were of age 2 to 11. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Vehicle was applied BID to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '0.0', 'groupId': 'OG002'}, {'value': '3.0', 'spread': '0.0', 'groupId': 'OG003'}, {'value': '3.0', 'spread': '0.0', 'groupId': 'OG004'}, {'value': '3.0', 'spread': '0.0', 'groupId': 'OG005'}, {'value': '3.0', 'spread': '0.0', 'groupId': 'OG006'}, {'value': '3.0', 'spread': '0.0', 'groupId': 'OG007'}]}]}, {'title': 'Change at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '0.12', 'groupId': 'OG001'}, {'value': '-1.1', 'spread': '0.20', 'groupId': 'OG002'}, {'value': '-0.7', 'spread': '0.12', 'groupId': 'OG003'}, {'value': '-1.4', 'spread': '0.19', 'groupId': 'OG004'}, {'value': '-1.0', 'spread': '0.20', 'groupId': 'OG005'}, {'value': '-1.2', 'spread': '0.18', 'groupId': 'OG006'}, {'value': '-0.8', 'spread': '0.16', 'groupId': 'OG007'}]}]}, {'title': 'Change at Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '0.15', 'groupId': 'OG001'}, {'value': '-1.9', 'spread': '0.19', 'groupId': 'OG002'}, {'value': '-1.1', 'spread': '0.19', 'groupId': 'OG003'}, {'value': '-1.8', 'spread': '0.22', 'groupId': 'OG004'}, {'value': '-1.1', 'spread': '0.19', 'groupId': 'OG005'}, {'value': '-1.9', 'spread': '0.16', 'groupId': 'OG006'}, {'value': '-0.9', 'spread': '0.20', 'groupId': 'OG007'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '-0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.17', 'groupDescription': 'Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '0.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.21', 'groupDescription': 'Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'groupDescription': 'Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '0.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.20', 'groupDescription': 'Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least square mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.27', 'groupDescription': 'Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG004', 'OG006'], 'paramType': 'Difference of least square mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.26', 'groupDescription': 'Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '-0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.22', 'groupDescription': 'Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '-0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.25', 'groupDescription': 'Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '-0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '-0.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.21', 'groupDescription': 'Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least square mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.27', 'groupDescription': 'Change at Day 15, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG005', 'OG007'], 'paramType': 'Difference of least square mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.28', 'groupDescription': 'Change at Day 15, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 8, Day 15', 'description': 'ISGA assessed the severity of AD on a 5-point scale ranged from 0 (clear) to 4 (severe), where higher scores indicated higher degree of AD. Grades for classification of severity: 0= clear (minor residual hypo/hyper pigmentation, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized and received greater than or equal to 1 dose of investigational product. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Crisaborole 2% QD: Age Group >=12 Years', 'description': 'Participants in this reporting arm were of age \\>=12 years. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied QD to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG001', 'title': 'Vehicle QD: Age Group >=12 Years', 'description': 'Participants in this reporting arm were of age \\>=12 years. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Vehicle was applied QD to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG002', 'title': 'Crisaborole 2% BID: Age Group >=12 Years', 'description': 'Participants in this reporting arm were of age \\>=12 years. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied BID to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG003', 'title': 'Vehicle BID: Age Group >=12 Years', 'description': 'Participants in this reporting arm were of age \\>=12 years. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Vehicle was applied BID to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.3', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '0.57', 'groupId': 'OG001'}, {'value': '5.1', 'spread': '0.47', 'groupId': 'OG002'}, {'value': '5.3', 'spread': '0.43', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 2', 'categories': [{'measurements': [{'value': '-1.3', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.38', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '0.20', 'groupId': 'OG002'}, {'value': '-0.5', 'spread': '0.37', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 3', 'categories': [{'measurements': [{'value': '-1.7', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '0.49', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '0.30', 'groupId': 'OG002'}, {'value': '-1.2', 'spread': '0.36', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 4', 'categories': [{'measurements': [{'value': '-2.5', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '0.55', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': '0.32', 'groupId': 'OG002'}, {'value': '-1.2', 'spread': '0.44', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 5', 'categories': [{'measurements': [{'value': '-2.6', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '0.46', 'groupId': 'OG001'}, {'value': '-2.6', 'spread': '0.37', 'groupId': 'OG002'}, {'value': '-1.8', 'spread': '0.40', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 6', 'categories': [{'measurements': [{'value': '-2.8', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '0.51', 'groupId': 'OG001'}, {'value': '-2.2', 'spread': '0.45', 'groupId': 'OG002'}, {'value': '-1.9', 'spread': '0.46', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 7', 'categories': [{'measurements': [{'value': '-2.9', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '0.56', 'groupId': 'OG001'}, {'value': '-2.5', 'spread': '0.39', 'groupId': 'OG002'}, {'value': '-2.1', 'spread': '0.45', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 8', 'categories': [{'measurements': [{'value': '-3.2', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '0.56', 'groupId': 'OG001'}, {'value': '-2.8', 'spread': '0.40', 'groupId': 'OG002'}, {'value': '-2.2', 'spread': '0.48', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 9', 'categories': [{'measurements': [{'value': '-3.2', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '0.55', 'groupId': 'OG001'}, {'value': '-2.7', 'spread': '0.57', 'groupId': 'OG002'}, {'value': '-2.3', 'spread': '0.46', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 10', 'categories': [{'measurements': [{'value': '-3.3', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '0.61', 'groupId': 'OG001'}, {'value': '-3.0', 'spread': '0.44', 'groupId': 'OG002'}, {'value': '-2.0', 'spread': '0.58', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 11', 'categories': [{'measurements': [{'value': '-3.5', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '0.55', 'groupId': 'OG001'}, {'value': '-3.1', 'spread': '0.41', 'groupId': 'OG002'}, {'value': '-2.3', 'spread': '0.49', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 12', 'categories': [{'measurements': [{'value': '-3.5', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '-3.3', 'spread': '0.44', 'groupId': 'OG002'}, {'value': '-2.3', 'spread': '0.50', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 13', 'categories': [{'measurements': [{'value': '-3.4', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '0.57', 'groupId': 'OG001'}, {'value': '-3.5', 'spread': '0.45', 'groupId': 'OG002'}, {'value': '-2.4', 'spread': '0.46', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 14', 'categories': [{'measurements': [{'value': '-3.3', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '0.65', 'groupId': 'OG001'}, {'value': '-3.6', 'spread': '0.43', 'groupId': 'OG002'}, {'value': '-2.6', 'spread': '0.47', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 15', 'categories': [{'measurements': [{'value': '-3.5', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '0.63', 'groupId': 'OG001'}, {'value': '-3.7', 'spread': '0.47', 'groupId': 'OG002'}, {'value': '-2.9', 'spread': '0.46', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '-0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.20', 'groupDescription': 'Change at Day 2, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.28', 'groupDescription': 'Change at Day 2, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '1.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.54', 'groupDescription': 'Change at Day 2, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.32', 'groupDescription': 'Change at Day 3, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.32', 'groupDescription': 'Change at Day 3, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least square mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '1.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.55', 'groupDescription': 'Change at Day 3, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '-0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.38', 'groupDescription': 'Change at Day 4, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '-0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.34', 'groupDescription': 'Change at Day 4, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least square mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '1.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.50', 'groupDescription': 'Change at Day 4, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-1.9', 'ciUpperLimit': '-0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.40', 'groupDescription': 'Change at Day 5, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '-0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.34', 'groupDescription': 'Change at Day 5, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least square mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '1.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.52', 'groupDescription': 'Change at Day 5, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '-0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.42', 'groupDescription': 'Change at Day 6, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.37', 'groupDescription': 'Change at Day 6, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least square mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '1.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.51', 'groupDescription': 'Change at Day 6, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '-0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.52', 'groupDescription': 'Change at Day 7, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.29', 'groupDescription': 'Change at Day 7, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least square mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '1.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.45', 'groupDescription': 'Change at Day 7, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '-0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.40', 'groupDescription': 'Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.35', 'groupDescription': 'Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least square mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '1.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.44', 'groupDescription': 'Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.7', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '-0.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.36', 'groupDescription': 'Change at Day 9, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '0.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.52', 'groupDescription': 'Change at Day 9, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least square mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '1.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.59', 'groupDescription': 'Change at Day 9, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '-0.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.31', 'groupDescription': 'Change at Day 10, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '-0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.47', 'groupDescription': 'Change at Day 10, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '1.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.49', 'groupDescription': 'Change at Day 10, Inter-participant: Mixed effect Model for Repeated Measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '0.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.42', 'groupDescription': 'Change at Day 11, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '-0.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.38', 'groupDescription': 'Change at Day 11, Intra-participant: MMRM included the fixed effect of day, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '1.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.44', 'groupDescription': 'Change at Day 11, Inter-participant: Mixed effect Model for Repeated Measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '-0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.34', 'groupDescription': 'Change at Day 12, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '0.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.47', 'groupDescription': 'Change at Day 12, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '1.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.52', 'groupDescription': 'Change at Day 12, Inter-participant: Mixed effect Model for Repeated Measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '-0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.35', 'groupDescription': 'Change at Day 13, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '-0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.47', 'groupDescription': 'Change at Day 13, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '0.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.53', 'groupDescription': 'Change at Day 13, Inter-participant: Mixed effect Model for Repeated Measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-1.9', 'ciUpperLimit': '-0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.31', 'groupDescription': 'Change at Day 14, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '-0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.42', 'groupDescription': 'Change at Day 14, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '0.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.53', 'groupDescription': 'Change at Day 14, Inter-participant: Mixed effect Model for Repeated Measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '-0.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.34', 'groupDescription': 'Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '0.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.36', 'groupDescription': 'Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least square mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '0.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.53', 'groupDescription': 'Change at Day 15, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15', 'description': 'The severity of itch (pruritus) due to AD at the target lesion was assessed using the peak pruritus NRS. Participants aged 12 years or more, were asked to rate their itch severity at the worst moment during the past 24 hours on a scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores represented more severe itch.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized and received greater than or equal to 1 dose of investigational product.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Crisaborole 2% QD Sub-group: Age Group 6 to 11 Years', 'description': 'Participants in this sub-group were of age 6 to 11 Years. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied QD to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG001', 'title': 'Vehicle QD Sub-group: Age Group 6 to 11 Years', 'description': 'Participants in this sub-group were of age 6 to 11 Years. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Vehicle was applied QD to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG002', 'title': 'Crisaborole 2% BID Sub-group: Age Group 6 to 11 Years', 'description': 'Participants in this sub-group were of age 6 to 11 Years. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied BID to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG003', 'title': 'Vehicle BID Sub-group: Age Group 6 to 11 Years', 'description': 'Participants in this sub-group were of age 6 to 11 years. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Vehicle was applied BID to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.6', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '0.32', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '0.33', 'groupId': 'OG002'}, {'value': '1.6', 'spread': '0.34', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 2', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.35', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '0.45', 'groupId': 'OG002'}, {'value': '-0.4', 'spread': '0.44', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 3', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.26', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '0.30', 'groupId': 'OG002'}, {'value': '-0.3', 'spread': '0.46', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 4', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.32', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '0.46', 'groupId': 'OG002'}, {'value': '-0.7', 'spread': '0.46', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 5', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.35', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '0.47', 'groupId': 'OG002'}, {'value': '-0.3', 'spread': '0.30', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 6', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.34', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '0.38', 'groupId': 'OG002'}, {'value': '-0.8', 'spread': '0.33', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 7', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.31', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '0.45', 'groupId': 'OG002'}, {'value': '-0.8', 'spread': '0.43', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 8', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.36', 'groupId': 'OG001'}, {'value': '-1.1', 'spread': '0.44', 'groupId': 'OG002'}, {'value': '-0.6', 'spread': '0.37', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 9', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.31', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '0.37', 'groupId': 'OG002'}, {'value': '-1.0', 'spread': '0.26', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 10', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.34', 'groupId': 'OG001'}, {'value': '-1.1', 'spread': '0.33', 'groupId': 'OG002'}, {'value': '-0.9', 'spread': '0.32', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 11', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.38', 'groupId': 'OG001'}, {'value': '-1.1', 'spread': '0.49', 'groupId': 'OG002'}, {'value': '-0.7', 'spread': '0.32', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 12', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.40', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '0.37', 'groupId': 'OG002'}, {'value': '-0.7', 'spread': '0.45', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 13', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.34', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '0.37', 'groupId': 'OG002'}, {'value': '-0.7', 'spread': '0.44', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 14', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.31', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '0.41', 'groupId': 'OG002'}, {'value': '-1.0', 'spread': '0.36', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 15', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.26', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '0.44', 'groupId': 'OG002'}, {'value': '-0.9', 'spread': '0.38', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.27', 'groupDescription': 'Change at Day 2, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.41', 'groupDescription': 'Change at Day 2, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '1.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.40', 'groupDescription': 'Change at Day 2, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.30', 'groupDescription': 'Change at Day 3, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.41', 'groupDescription': 'Change at Day 3, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.36', 'groupDescription': 'Change at Day 3, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '96', 'paramValue': '0.0', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '1.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.52', 'groupDescription': 'Change at Day 4, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '0.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.41', 'groupDescription': 'Change at Day 4, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '0.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.43', 'groupDescription': 'Change at Day 4, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.36', 'groupDescription': 'Change at Day 5, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.41', 'groupDescription': 'Change at Day 5, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '1.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.44', 'groupDescription': 'Change at Day 5, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '0.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.42', 'groupDescription': 'Change at Day 6, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '0.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.41', 'groupDescription': 'Change at Day 6, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.33', 'groupDescription': 'Change at Day 6, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.43', 'groupDescription': 'Change at Day 7, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.41', 'groupDescription': 'Change at Day 7, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.42', 'groupDescription': 'Change at Day 7, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.42', 'groupDescription': 'Change at Day 8, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.41', 'groupDescription': 'Change at Day 8, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.32', 'groupDescription': 'Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '0.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.44', 'groupDescription': 'Change at Day 9, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.41', 'groupDescription': 'Change at Day 9, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.33', 'groupDescription': 'Change at Day 9, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '0.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.45', 'groupDescription': 'Change at Day 10, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.41', 'groupDescription': 'Change at Day 10, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.31', 'groupDescription': 'Change at Day 10, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.45', 'groupDescription': 'Change at Day 11, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '1.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.36', 'groupDescription': 'Change at Day 11, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.41', 'groupDescription': 'Change at Day 11, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-1.9', 'ciUpperLimit': '0.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.43', 'groupDescription': 'Change at Day 12, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.41', 'groupDescription': 'Change at Day 12, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.37', 'groupDescription': 'Change at Day 12, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.44', 'groupDescription': 'Change at Day 13, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.41', 'groupDescription': 'Change at Day 13, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.34', 'groupDescription': 'Change at Day 13, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.42', 'groupDescription': 'Change at Day 14, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.41', 'groupDescription': 'Change at Day 14, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.39', 'groupDescription': 'Change at Day 14, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.34', 'groupDescription': 'Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.41', 'groupDescription': 'Change at Day 15, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.39', 'groupDescription': 'Change at Day 15, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15', 'description': 'The itch severity scale was used for participants \\>=6 to 11 years of age to assess severity of itch (pruritus) due to AD at the target lesion. In this assessment, participants were asked to choose a unit that showed how itchy their skin had been on day of assessment on a 5-point scale ranging from 1= not itchy to 5= very itchy, where higher scores represented more severe itch.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all participants who were randomized and received greater than or equal to 1 dose of investigational product and aged between 6 to 11 years. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Crisaborole 2% QD: Age Group 2 to 11 Years', 'description': 'Participants in this reporting arm were of age 2 to 11. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied QD to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG001', 'title': 'Vehicle QD: Age Group 2 to 11 Years', 'description': 'Participants in this reporting arm were of age 2 to 11. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Vehicle was applied QD to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG002', 'title': 'Crisaborole 2% BID: Age Group 2 to 11 Years', 'description': 'Participants in this reporting arm were of age 2 to 11. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied BID to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG003', 'title': 'Vehicle BID: Age Group 2 to 11 Years', 'description': 'Participants in this reporting arm were of age 2 to 11. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Vehicle was applied BID to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.7', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '5.5', 'spread': '0.56', 'groupId': 'OG002'}, {'value': '5.1', 'spread': '0.56', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 2', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.31', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '0.40', 'groupId': 'OG002'}, {'value': '-0.9', 'spread': '0.50', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 3', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.35', 'groupId': 'OG001'}, {'value': '-1.6', 'spread': '0.47', 'groupId': 'OG002'}, {'value': '-1.3', 'spread': '0.55', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 4', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.38', 'groupId': 'OG001'}, {'value': '-1.8', 'spread': '0.64', 'groupId': 'OG002'}, {'value': '-1.6', 'spread': '0.58', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 5', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.60', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': '0.66', 'groupId': 'OG002'}, {'value': '-2.1', 'spread': '0.52', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 6', 'categories': [{'measurements': [{'value': '-1.9', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '0.43', 'groupId': 'OG001'}, {'value': '-2.7', 'spread': '0.62', 'groupId': 'OG002'}, {'value': '-2.2', 'spread': '0.66', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 7', 'categories': [{'measurements': [{'value': '-2.0', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '0.45', 'groupId': 'OG001'}, {'value': '-3.0', 'spread': '0.64', 'groupId': 'OG002'}, {'value': '-1.9', 'spread': '0.71', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 8', 'categories': [{'measurements': [{'value': '-2.3', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '0.36', 'groupId': 'OG001'}, {'value': '-3.3', 'spread': '0.66', 'groupId': 'OG002'}, {'value': '-2.0', 'spread': '0.70', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 9', 'categories': [{'measurements': [{'value': '-2.0', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '0.42', 'groupId': 'OG001'}, {'value': '-3.4', 'spread': '0.61', 'groupId': 'OG002'}, {'value': '-2.5', 'spread': '0.63', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 10', 'categories': [{'measurements': [{'value': '-2.2', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '0.42', 'groupId': 'OG001'}, {'value': '-3.9', 'spread': '0.62', 'groupId': 'OG002'}, {'value': '-2.3', 'spread': '0.65', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 11', 'categories': [{'measurements': [{'value': '-2.4', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '0.45', 'groupId': 'OG001'}, {'value': '-3.5', 'spread': '0.69', 'groupId': 'OG002'}, {'value': '-2.4', 'spread': '0.66', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 12', 'categories': [{'measurements': [{'value': '-2.1', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.61', 'groupId': 'OG001'}, {'value': '-4.1', 'spread': '0.60', 'groupId': 'OG002'}, {'value': '-2.5', 'spread': '0.65', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 13', 'categories': [{'measurements': [{'value': '-2.1', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '-4.1', 'spread': '0.54', 'groupId': 'OG002'}, {'value': '-2.6', 'spread': '0.70', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 14', 'categories': [{'measurements': [{'value': '-2.4', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '0.49', 'groupId': 'OG001'}, {'value': '-4.3', 'spread': '0.56', 'groupId': 'OG002'}, {'value': '-2.8', 'spread': '0.66', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 15', 'categories': [{'measurements': [{'value': '-2.5', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '0.45', 'groupId': 'OG001'}, {'value': '-4.3', 'spread': '0.63', 'groupId': 'OG002'}, {'value': '-3.0', 'spread': '0.61', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '0.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.39', 'groupDescription': 'Change at Day 2, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '1.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.36', 'groupDescription': 'Change at Day 2, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '1.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.50', 'groupDescription': 'Change at Day 2, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.33', 'groupDescription': 'Change at Day 3, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '1.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.58', 'groupDescription': 'Change at Day 3, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.53', 'groupDescription': 'Change at Day 3, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '0.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.45', 'groupDescription': 'Change at Day 4, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '1.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.62', 'groupDescription': 'Change at Day 4, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '0.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.74', 'groupDescription': 'Change at Day 4, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '-0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.39', 'groupDescription': 'Change at Day 5, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '1.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.66', 'groupDescription': 'Change at Day 5, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '1.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.70', 'groupDescription': 'Change at Day 5, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '0.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.46', 'groupDescription': 'Change at Day 6, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.47', 'groupDescription': 'Change at Day 6, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '0.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.63', 'groupDescription': 'Change at Day 6, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '-0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.42', 'groupDescription': 'Change at Day 7, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '-0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.48', 'groupDescription': 'Change at Day 7, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.9', 'ciUpperLimit': '0.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.61', 'groupDescription': 'Change at Day 7, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '0.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.49', 'groupDescription': 'Change at Day 8, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '-0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.52', 'groupDescription': 'Change at Day 8, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.9', 'ciUpperLimit': '0.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.64', 'groupDescription': 'Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '-0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.54', 'groupDescription': 'Change at Day 9, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-1.9', 'ciUpperLimit': '0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.49', 'groupDescription': 'Change at Day 9, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.63', 'groupDescription': 'Change at Day 9, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '-0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.54', 'groupDescription': 'Change at Day 10, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-2.5', 'ciUpperLimit': '-0.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.45', 'groupDescription': 'Change at Day 10, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-2.6', 'ciUpperLimit': '-0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.58', 'groupDescription': 'Change at Day 10, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '-0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.54', 'groupDescription': 'Change at Day 11, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '-0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.51', 'groupDescription': 'Change at Day 11, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.67', 'groupDescription': 'Change at Day 11, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5', 'ciLowerLimit': '-2.9', 'ciUpperLimit': '0.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.70', 'groupDescription': 'Change at Day 12, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '-0.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.40', 'groupDescription': 'Change at Day 12, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-2.9', 'ciUpperLimit': '-0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.63', 'groupDescription': 'Change at Day 12, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-2.5', 'ciUpperLimit': '0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.68', 'groupDescription': 'Change at Day 13, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '-0.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.44', 'groupDescription': 'Change at Day 13, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.7', 'ciLowerLimit': '-3.0', 'ciUpperLimit': '-0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.62', 'groupDescription': 'Change at Day 13, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-2.5', 'ciUpperLimit': '-0.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.45', 'groupDescription': 'Change at Day 14, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '-0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.59', 'groupDescription': 'Change at Day 14, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-2.5', 'ciUpperLimit': '0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.62', 'groupDescription': 'Change at Day 14, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '-0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.57', 'groupDescription': 'Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '-0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.46', 'groupDescription': 'Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '-0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.66', 'groupDescription': 'Change at Day 15, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15', 'description': "Observer reported itch severity NRS was used for participants \\>=2 and \\< 12 years of age to assess severity of itch (pruritus) due to AD at the target lesion. Parents/caregivers (of participants) were asked to rate participants' itch (i.e. scratching, rubbing) at the worst moment during past 24 hours on a scale of 0 (no itch) to 10 (worst itch imaginable); higher scores represented more severe itch.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized and received greater than or equal to 1 dose of investigational product.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}, {'value': '40', 'groupId': 'OG008'}, {'value': '40', 'groupId': 'OG009'}, {'value': '41', 'groupId': 'OG010'}, {'value': '41', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Crisaborole 2% QD: Age Group >=12 Years', 'description': 'Participants in this reporting arm were of age \\>=12 years. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied QD to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG001', 'title': 'Vehicle QD: Age Group >=12 Years', 'description': 'Participants in this reporting arm were of age \\>=12 years. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Vehicle was applied QD to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG002', 'title': 'Crisaborole 2% BID: Age Group >=12 Years', 'description': 'Participants in this reporting arm were of age \\>=12 years. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied BID to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG003', 'title': 'Vehicle BID: Age Group >=12 Years', 'description': 'Participants in this reporting arm were of age \\>=12 years. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Vehicle was applied BID to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG004', 'title': 'Crisaborole 2% QD: Age Group 2 to 11 Years', 'description': 'Participants in this reporting arm were of age 2 to 11. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied QD to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG005', 'title': 'Vehicle QD: Age Group 2 to 11 Years', 'description': 'Participants in this reporting arm were of age 2 to 11. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Vehicle was applied QD to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG006', 'title': 'Crisaborole 2% BID: Age Group 2 to 11 Years', 'description': 'Participants in this reporting arm were of age 2 to 11. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied BID to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG007', 'title': 'Vehicle BID: Age Group 2 to 11 Years', 'description': 'Participants in this reporting arm were of age 2 to 11. Investigator determined 2 target lesions of same atopic dermatitis severity in each participant at baseline (Day 1). Vehicle was applied BID to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG008', 'title': 'Crisaborole 2% QD: All Age Group', 'description': 'Crisaborole ointment 2% was applied QD to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG009', 'title': 'Vehicle QD: All Age Group', 'description': 'Vehicle was applied QD to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG010', 'title': 'Crisaborole 2% BID: All Age Group', 'description': 'Crisaborole ointment 2% was applied BID to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG011', 'title': 'Vehicle BID: All Age Group', 'description': 'Vehicle was applied BID to 1 of the target lesions for 15 days and participants were followed up to 35 days after the end of treatment (maximum up to Day 50).'}], 'classes': [{'title': 'Application site coldness', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}]}, {'title': 'Application site irritation', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}]}, {'title': 'Application site pain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Application site pruritus', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}]}, {'title': 'Application site folliculitis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 up to 35 days after end of treatment (maximum up to Day 50)', 'description': 'An AE was any untoward medical occurrence attributed to a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug and up to end of study that were absent before treatment or that worsened relative to pre-treatment state. For this outcome measure, treatment-emergent AEs occurred at each treated target lesion were summarized. MedDRA version 22.1 coding dictionary was used.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants receiving greater than or equal to 1 dose of investigational product. Treatment emergent AEs and SAEs occurred in the target lesions were planned to be summarized by treatment in each regimen for each cohort and pooled cohort.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) by Treatment Regimen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Crisaborole 2% QD + Vehicle QD, Age Group >=12 Years', 'description': 'Participants in this reporting arm were of age \\>=12 years. Investigator determined 2 target lesions of same AD severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied QD to 1 of the target lesions and vehicle was applied QD to another target lesion (intra-participant) for 15 days and participants were followed up to maximum of 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG001', 'title': 'Cohort 1:Crisaborole 2% BID + Vehicle BID,Age Group >=12 Years', 'description': 'Participants in this reporting arm were of age \\>=12 years. Investigator determined 2 target lesions of same AD severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied BID to 1 of the target lesions and vehicle was applied BID to another target lesion (intra-participant) for 15 days and participants were followed up to maximum of 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG002', 'title': 'Cohort 2:Crisaborole 2% QD + Vehicle QD, Age Group 2-11 Years', 'description': 'Participants in this reporting arm were of age 2 to 11 years. Investigator determined 2 target lesions of same AD severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied QD to 1 of the target lesions and vehicle was applied QD to another target lesion (intra-participant) for 15 days and participants were followed up to maximum of 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'OG003', 'title': 'Cohort 2:Crisaborole 2% BID + Vehicle BID,Age Group 2-11 Years', 'description': 'Participants in this reporting arm were of age 2 to 11 years. Investigator determined 2 target lesions of same AD severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied BID to 1 of the target lesions and vehicle was applied BID to another target lesion (intra-participant) for 15 days and participants were followed up to maximum of 35 days after the end of treatment (maximum up to Day 50).'}], 'classes': [{'title': 'Participants With AEs', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Participants With SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 up to 35 days after end of treatment (maximum up to Day 50)', 'description': 'An AE was any untoward medical occurrence attributed to a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to end of study that were absent before treatment or that worsened relative to pre-treatment state.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants receiving greater than or equal to 1 dose of investigational product.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1: Crisaborole 2% QD + Vehicle QD, Age Group >=12 Years', 'description': 'Participants in this reporting arm were of age greater than or equal to (\\>=) 12 years. Investigator determined 2 target lesions of same atopic dermatitis (AD) severity in each participant at baseline (Day 1). Crisaborole ointment 2 percent (%) was applied once daily (QD) to 1 of the target lesions and vehicle was applied QD to another target lesion (intra-participant) for 15 days and participants were followed up to maximum of 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'FG001', 'title': 'Cohort 1:Crisaborole 2% BID + Vehicle BID,Age Group >=12 Years', 'description': 'Participants in this reporting arm were of age \\>=12 years. Investigator determined 2 target lesions of same AD severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied twice daily (BID) to 1 of the target lesions and vehicle was applied BID to another target lesion (intra-participant) for 15 days and participants were followed up to maximum of 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'FG002', 'title': 'Cohort 2:Crisaborole 2% QD + Vehicle QD, Age Group 2-11 Years', 'description': 'Participants in this reporting arm were of age 2 to 11 years. Investigator determined 2 target lesions of same AD severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied QD to 1 of the target lesions and vehicle was applied QD to another target lesion (intra-participant) for 15 days and participants were followed up to maximum of 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'FG003', 'title': 'Cohort 2:Crisaborole 2% BID + Vehicle BID,Age Group 2-11 Years', 'description': 'Participants in this reporting arm were of age 2 to 11 years. Investigator determined 2 target lesions of same AD severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied BID to 1 of the target lesions and vehicle was applied BID to another target lesion (intra-participant) for 15 days and participants were followed up to maximum of 35 days after the end of treatment (maximum up to Day 50).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '81', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1: Crisaborole 2% QD + Vehicle QD, Age Group >=12 Years', 'description': 'Participants in this reporting arm were of age \\>=12 years. Investigator determined 2 target lesions of same AD severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied QD to 1 of the target lesions and vehicle was applied QD to another target lesion (intra-participant) for 15 days and participants were followed up to maximum of 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'BG001', 'title': 'Cohort 1:Crisaborole 2% BID + Vehicle BID,Age Group >=12 Years', 'description': 'Participants in this reporting arm were of age \\>=12 years. Investigator determined 2 target lesions of same AD severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied BID to 1 of the target lesions and vehicle was applied BID to another target lesion (intra-participant) for 15 days and participants were followed up to maximum of 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'BG002', 'title': 'Cohort 2:Crisaborole 2% QD + Vehicle QD, Age Group 2-11 Years', 'description': 'Participants in this reporting arm were of age 2 to 11 years. Investigator determined 2 target lesions of same AD severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied QD to 1 of the target lesions and vehicle was applied QD to another target lesion (intra-participant) for 15 days and participants were followed up to maximum of 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'BG003', 'title': 'Cohort 2:Crisaborole 2% BID + Vehicle BID,Age Group 2-11 Years', 'description': 'Participants in this reporting arm were of age 2 to 11 years. Investigator determined 2 target lesions of same AD severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied BID to 1 of the target lesions and vehicle was applied BID to another target lesion (intra-participant) for 15 days and participants were followed up to maximum of 35 days after the end of treatment (maximum up to Day 50).'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '47', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '81', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '81', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set (FAS) included all participants who were randomized and received \\>=1 dose of investigational product.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-12-19', 'size': 2103628, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-05-26T16:33', 'hasProtocol': False}, {'date': '2019-02-22', 'size': 2329040, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-05-27T12:02', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-05', 'studyFirstSubmitDate': '2019-05-15', 'resultsFirstSubmitDate': '2020-05-27', 'studyFirstSubmitQcDate': '2019-05-15', 'lastUpdatePostDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-05', 'studyFirstPostDateStruct': {'date': '2019-05-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Total Sign Score (TSS) in Target Lesions at Day 15: Crisaborole Ointment 2% Versus Vehicle', 'timeFrame': 'Baseline, Day 15', 'description': 'Lesion TSS was an assessment of the target lesion severity, which was based on severity of 4 clinical signs erythema, induration/papulation, excoriation and lichenification. All of these 4 signs were rated on a scale of 0 to 3 (0= none, 1= mild, 2= moderate, 3= severe). These ratings were added to create a total TSS score; ranging from 0 (none) to 12 (most severe), with higher score representing greater severity.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Total Sign Score in Target Lesions at Day 15: Crisaborole Ointment 2% BID Versus Crisaborole Ointment 2% QD', 'timeFrame': 'Baseline, Day 15', 'description': 'Lesion TSS was an assessment of the target lesion severity, which was based on severity of 4 clinical signs erythema, induration/papulation, excoriation and lichenification. All of these 4 signs were rated on a scale of 0 to 3 (0= none, 1= mild, 2= moderate, 3= severe). These ratings were added to create a total TSS score; ranging from 0 (none) to 12 (most severe), with higher score representing greater severity.'}, {'measure': 'Change From Baseline in Total Sign Score in Target Lesions at Day 8: Crisaborole Ointment 2% Versus Vehicle', 'timeFrame': 'Baseline, Day 8', 'description': 'Lesion TSS was an assessment of the target lesion severity, which was based on severity of 4 clinical signs erythema, induration/papulation, excoriation and lichenification. All of these 4 signs were rated on a scale of 0 to 3 (0= none, 1= mild, 2= moderate, 3= severe). These ratings were added to create a total TSS score; ranging from 0 (none) to 12 (most severe), with higher score representing greater severity.'}, {'measure': "Change From Baseline in Investigator's Static Global Assessment (ISGA) Score in Target Lesions at Day 8 and Day 15", 'timeFrame': 'Baseline, Day 8, Day 15', 'description': 'ISGA assessed the severity of AD on a 5-point scale ranged from 0 (clear) to 4 (severe), where higher scores indicated higher degree of AD. Grades for classification of severity: 0= clear (minor residual hypo/hyper pigmentation, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting).'}, {'measure': 'Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More', 'timeFrame': 'Baseline, Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15', 'description': 'The severity of itch (pruritus) due to AD at the target lesion was assessed using the peak pruritus NRS. Participants aged 12 years or more, were asked to rate their itch severity at the worst moment during the past 24 hours on a scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores represented more severe itch.'}, {'measure': 'Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years', 'timeFrame': 'Baseline, Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15', 'description': 'The itch severity scale was used for participants \\>=6 to 11 years of age to assess severity of itch (pruritus) due to AD at the target lesion. In this assessment, participants were asked to choose a unit that showed how itchy their skin had been on day of assessment on a 5-point scale ranging from 1= not itchy to 5= very itchy, where higher scores represented more severe itch.'}, {'measure': 'Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years', 'timeFrame': 'Baseline, Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15', 'description': "Observer reported itch severity NRS was used for participants \\>=2 and \\< 12 years of age to assess severity of itch (pruritus) due to AD at the target lesion. Parents/caregivers (of participants) were asked to rate participants' itch (i.e. scratching, rubbing) at the worst moment during past 24 hours on a scale of 0 (no itch) to 10 (worst itch imaginable); higher scores represented more severe itch."}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term', 'timeFrame': 'Day 1 up to 35 days after end of treatment (maximum up to Day 50)', 'description': 'An AE was any untoward medical occurrence attributed to a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug and up to end of study that were absent before treatment or that worsened relative to pre-treatment state. For this outcome measure, treatment-emergent AEs occurred at each treated target lesion were summarized. MedDRA version 22.1 coding dictionary was used.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) by Treatment Regimen', 'timeFrame': 'Day 1 up to 35 days after end of treatment (maximum up to Day 50)', 'description': 'An AE was any untoward medical occurrence attributed to a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to end of study that were absent before treatment or that worsened relative to pre-treatment state.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C3291028', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 2b, multi-center, randomized, double-blind, vehicle-controlled, intraparticipant study to evaluate efficacy and safety of two regimens of crisaborole ointment 2% in Japanese pediatric and adult participants (cohort 1: 12 years and older, cohort 2: 2 to under 12 years old) with mild to moderate Atopic Dermatitis (AD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female participants ages; Cohort 1: 12 years and older at the time of consent. Cohort 2: 2 years to under 12 years old at the time of consent.\n* Has confrimed clinical diagnosis of active AD according to Hanifin and Rajka criteria and has at least 6 months history prior to screening and has been clinically stable for more than 1 month\n* Has at least 1% and no more than 30% BSA at baseline/Day1, excluding scalp, genitals and groin area\n* Has a Investigator's static global assessment (ISGA) score of Mild (2) or Moderate (3) on Day 1.\n\nExclusion Criteria:\n\n* Has other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.\n* Participants had previous treatment with any topical or systemic PDE-4 inhibitor."}, 'identificationModule': {'nctId': 'NCT03954158', 'briefTitle': 'Study to Assess Efficacy and Safety of Two Regimens of Crisaborole Ointment 2% in Japanese Participants Aged ≥2 Years With Mild to Moderate Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 2b, Multi Center, Randomized, Double-Blind, Vehicle-Controlled, Intra-Participant Study, to Evaluate Efficacy and Safety of Two Regimens of Crisaborole Ointment 2% in Japanese Pediatric and Adult Participants (2 Years and Older) With Mild to Moderate Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'C3291028'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Crisaborole ointment 2% once daily (QD) vs vehicle QD', 'description': 'intra-participant comparison, treatment will be randomly assigned to target lesion 1 and lesion 2.', 'interventionNames': ['Drug: Crisaborole ointment 2%', 'Drug: Vehicle']}, {'type': 'EXPERIMENTAL', 'label': 'Crisaborole ointment 2% twice daily (BID) vs vehicle BID', 'description': 'Intra-participant comparison, treatment will be randomly assigned to target lesion 1 and lesion 2.', 'interventionNames': ['Drug: Crisaborole ointment 2%', 'Drug: Vehicle']}], 'interventions': [{'name': 'Crisaborole ointment 2%', 'type': 'DRUG', 'description': 'BID regimen', 'armGroupLabels': ['Crisaborole ointment 2% twice daily (BID) vs vehicle BID']}, {'name': 'Vehicle', 'type': 'DRUG', 'description': 'BID regimen', 'armGroupLabels': ['Crisaborole ointment 2% twice daily (BID) vs vehicle BID']}, {'name': 'Crisaborole ointment 2%', 'type': 'DRUG', 'description': 'QD regimen', 'armGroupLabels': ['Crisaborole ointment 2% once daily (QD) vs vehicle QD']}, {'name': 'Vehicle', 'type': 'DRUG', 'description': 'QD regimen', 'armGroupLabels': ['Crisaborole ointment 2% once daily (QD) vs vehicle QD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '532-0003', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Medical Corporation Heishinkai OPHAC Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '103-0027', 'city': 'Chuo-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Fukuwa Clinic'}, {'zip': '171-0014', 'city': 'Toshima-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Sekino Hospital'}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'url': 'https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests', 'ipdSharing': 'YES', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}