Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-02-27 @ 7:06 PM
Study NCT ID:
NCT03858634
Status:
COMPLETED
Last Update Posted:
2025-03-18
First Post:
2019-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-11-12', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080223', 'term': 'Chronic Urticaria'}, {'id': 'D008010', 'term': 'Lichen Planus'}, {'id': 'D009450', 'term': 'Neurodermatitis'}, {'id': 'D011537', 'term': 'Pruritus'}], 'ancestors': [{'id': 'D014581', 'term': 'Urticaria'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017512', 'term': 'Lichenoid Eruptions'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800 821-8590', 'title': 'Medical Communications', 'organization': 'Genentech, Inc.'}, 'certainAgreement': {'otherDetails': "Sponsor has the first right to publish study results. PI may publish study results after Sponsor publishes the study results or 18 months after study completion at all participating sites, whichever comes first, provided that Sponsor may embargo such publication for up to 60 days for purposes of identifying confidential information that must be removed and up to an additional 60 days to prepare a patent application if there is patentable subject matter in the PI's proposed publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study treatment through the end-of-study visit (Week 18).', 'description': 'The adverse event data are presented by combined cohorts for public reporting purposes because the low numbers of participants in the individual disease-specific cohorts may cause re-identification concerns if presented separately.', 'eventGroups': [{'id': 'EG000', 'title': 'KPL-716', 'description': 'KPL-716 weekly for 8 weeks', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 15, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo weekly for 8 weeks', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 11, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Lymphangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Streptococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pityriasis rosea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cardiac murmur', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Electrocardioagram T wave abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Muscle contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vitamin B12 deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Chalazion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'seriousEvents': [{'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Weekly Average WI-NRS at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'KPL-716: CIU Cohort', 'description': 'Participants with CIU received KPL-716 weekly for 8 weeks'}, {'id': 'OG001', 'title': 'Placebo: CIU Cohort', 'description': 'Participants with CIU received placebo weekly for 8 weeks'}, {'id': 'OG002', 'title': 'KPL-716: CIP Cohort', 'description': 'Participants with CIP received KPL-716 weekly for 8 weeks'}, {'id': 'OG003', 'title': 'Placebo: CIP Cohort', 'description': 'Participants with CIP received placebo weekly for 8 weeks'}, {'id': 'OG004', 'title': 'KPL-716: LP Cohort', 'description': 'Participants with LP received KPL-716 weekly for 8 weeks'}, {'id': 'OG005', 'title': 'Placebo: LP Cohort', 'description': 'Participants with LP received placebo weekly for 8 weeks'}, {'id': 'OG006', 'title': 'KPL-716: LSC Cohort', 'description': 'Participants with LSC received KPL-716 weekly for 8 weeks'}, {'id': 'OG007', 'title': 'Placebo: LSC Cohort', 'description': 'Participants with LSC received placebo weekly for 8 weeks'}, {'id': 'OG008', 'title': 'KPL-716: PPs Cohort', 'description': 'Participants with PPs received KPL-716 weekly for 8 weeks'}, {'id': 'OG009', 'title': 'Placebo: PPs Cohort', 'description': 'Participants with PPs received placebo weekly for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.3', 'spread': '1.84', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '2.66', 'groupId': 'OG001'}, {'value': '-4.3', 'spread': '0.77', 'groupId': 'OG002'}, {'value': '-3.7', 'spread': '0.96', 'groupId': 'OG003'}, {'value': '-3.1', 'spread': '0.82', 'groupId': 'OG004'}, {'value': '-6.9', 'spread': '0.81', 'groupId': 'OG006'}, {'value': '0.7', 'spread': '1.84', 'groupId': 'OG007'}, {'value': '-5.6', 'spread': '0.69', 'groupId': 'OG008'}, {'value': '-2.5', 'spread': '0.98', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '0.3980', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares (LS) mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-3.3', 'ciLowerLimit': '-8.68', 'ciUpperLimit': '2.17', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.31', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6653', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.5', 'ciLowerLimit': '-2.17', 'ciUpperLimit': '1.09', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.23', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0711', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-7.6', 'ciLowerLimit': '-11.63', 'ciUpperLimit': '-3.56', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.14', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0186', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-3.1', 'ciLowerLimit': '-4.70', 'ciUpperLimit': '-1.51', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.20', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 8', 'description': 'WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Weekly Average WI-NRS Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'KPL-716: CIU Cohort', 'description': 'Participants with CIU received KPL-716 weekly for 8 weeks'}, {'id': 'OG001', 'title': 'Placebo: CIU Cohort', 'description': 'Participants with CIU received placebo weekly for 8 weeks'}, {'id': 'OG002', 'title': 'KPL-716: CIP Cohort', 'description': 'Participants with CIP received KPL-716 weekly for 8 weeks'}, {'id': 'OG003', 'title': 'Placebo: CIP Cohort', 'description': 'Participants with CIP received placebo weekly for 8 weeks'}, {'id': 'OG004', 'title': 'KPL-716: LP Cohort', 'description': 'Participants with LP received KPL-716 weekly for 8 weeks'}, {'id': 'OG005', 'title': 'Placebo: LP Cohort', 'description': 'Participants with LP received placebo weekly for 8 weeks'}, {'id': 'OG006', 'title': 'KPL-716: LSC Cohort', 'description': 'Participants with LSC received KPL-716 weekly for 8 weeks'}, {'id': 'OG007', 'title': 'Placebo: LSC Cohort', 'description': 'Participants with LSC received placebo weekly for 8 weeks'}, {'id': 'OG008', 'title': 'KPL-716: PPs Cohort', 'description': 'Participants with PPs received KPL-716 weekly for 8 weeks'}, {'id': 'OG009', 'title': 'Placebo: PPs Cohort', 'description': 'Participants with PPs received placebo weekly for 8 weeks'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '0.86', 'groupId': 'OG001'}, {'value': '-1.6', 'spread': '0.55', 'groupId': 'OG002'}, {'value': '-1.4', 'spread': '0.45', 'groupId': 'OG003'}, {'value': '-0.2', 'spread': '0.13', 'groupId': 'OG004'}, {'value': '-3.0', 'spread': '1.23', 'groupId': 'OG006'}, {'value': '-0.9', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-0.7', 'spread': '0.17', 'groupId': 'OG008'}, {'value': '-0.2', 'spread': '0.16', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '1.29', 'groupId': 'OG001'}, {'value': '-3.0', 'spread': '0.60', 'groupId': 'OG002'}, {'value': '-2.9', 'spread': '0.63', 'groupId': 'OG003'}, {'value': '-0.5', 'spread': '0.58', 'groupId': 'OG004'}, {'value': '-4.0', 'spread': '1.64', 'groupId': 'OG006'}, {'value': '-1.0', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-1.5', 'spread': '0.27', 'groupId': 'OG008'}, {'value': '-0.7', 'spread': '0.26', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-3.8', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '1.64', 'groupId': 'OG001'}, {'value': '-3.5', 'spread': '0.61', 'groupId': 'OG002'}, {'value': '-2.4', 'spread': '0.72', 'groupId': 'OG003'}, {'value': '-1.2', 'spread': '0.99', 'groupId': 'OG004'}, {'value': '-4.6', 'spread': '1.73', 'groupId': 'OG006'}, {'value': '-1.4', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-2.6', 'spread': '0.39', 'groupId': 'OG008'}, {'value': '-0.9', 'spread': '0.33', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-3.9', 'spread': '1.59', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '1.50', 'groupId': 'OG001'}, {'value': '-3.5', 'spread': '0.64', 'groupId': 'OG002'}, {'value': '-3.0', 'spread': '0.85', 'groupId': 'OG003'}, {'value': '-2.3', 'spread': '1.78', 'groupId': 'OG004'}, {'value': '-5.0', 'spread': '1.48', 'groupId': 'OG006'}, {'value': '-2.4', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-3.4', 'spread': '0.48', 'groupId': 'OG008'}, {'value': '-1.2', 'spread': '0.63', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-4.4', 'spread': '1.83', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '1.64', 'groupId': 'OG001'}, {'value': '-4.1', 'spread': '0.73', 'groupId': 'OG002'}, {'value': '-3.1', 'spread': '0.88', 'groupId': 'OG003'}, {'value': '-2.5', 'spread': '1.91', 'groupId': 'OG004'}, {'value': '-5.4', 'spread': '1.58', 'groupId': 'OG006'}, {'value': '-2.0', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-4.4', 'spread': '0.65', 'groupId': 'OG008'}, {'value': '-1.5', 'spread': '0.88', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-4.6', 'spread': '1.72', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '1.79', 'groupId': 'OG001'}, {'value': '-4.2', 'spread': '0.74', 'groupId': 'OG002'}, {'value': '-3.7', 'spread': '0.92', 'groupId': 'OG003'}, {'value': '-2.7', 'spread': '1.90', 'groupId': 'OG004'}, {'value': '-5.8', 'spread': '1.58', 'groupId': 'OG006'}, {'value': '-2.6', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-4.7', 'spread': '0.65', 'groupId': 'OG008'}, {'value': '-1.6', 'spread': '0.81', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-4.4', 'spread': '1.75', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '2.64', 'groupId': 'OG001'}, {'value': '-4.4', 'spread': '0.77', 'groupId': 'OG002'}, {'value': '-3.7', 'spread': '0.81', 'groupId': 'OG003'}, {'value': '-3.1', 'spread': '1.94', 'groupId': 'OG004'}, {'value': '-6.3', 'spread': '1.48', 'groupId': 'OG006'}, {'value': '-2.3', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-5.1', 'spread': '0.69', 'groupId': 'OG008'}, {'value': '-1.9', 'spread': '0.91', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-4.1', 'spread': '1.84', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '1.57', 'groupId': 'OG001'}, {'value': '-4.3', 'spread': '0.75', 'groupId': 'OG002'}, {'value': '-3.7', 'spread': '0.94', 'groupId': 'OG003'}, {'value': '-3.1', 'spread': '1.94', 'groupId': 'OG004'}, {'value': '-6.0', 'spread': '1.61', 'groupId': 'OG006'}, {'value': '-2.7', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-5.6', 'spread': '0.66', 'groupId': 'OG008'}, {'value': '-2.5', 'spread': '1.07', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-4.1', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '1.57', 'groupId': 'OG001'}, {'value': '-4.6', 'spread': '0.88', 'groupId': 'OG002'}, {'value': '-3.8', 'spread': '0.76', 'groupId': 'OG003'}, {'value': '-5.0', 'spread': '1.00', 'groupId': 'OG004'}, {'value': '-6.0', 'spread': '1.76', 'groupId': 'OG006'}, {'value': '-3.3', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-5.7', 'spread': '0.70', 'groupId': 'OG008'}, {'value': '-2.5', 'spread': '1.21', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-4.1', 'spread': '1.69', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '2.21', 'groupId': 'OG001'}, {'value': '-4.3', 'spread': '0.87', 'groupId': 'OG002'}, {'value': '-4.7', 'spread': '0.64', 'groupId': 'OG003'}, {'value': '-5.0', 'spread': '1.00', 'groupId': 'OG004'}, {'value': '-6.3', 'spread': '1.46', 'groupId': 'OG006'}, {'value': '-3.0', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-5.6', 'spread': '0.75', 'groupId': 'OG008'}, {'value': '-2.2', 'spread': '1.23', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-4.1', 'spread': '1.74', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '2.21', 'groupId': 'OG001'}, {'value': '-4.4', 'spread': '0.90', 'groupId': 'OG002'}, {'value': '-4.9', 'spread': '0.75', 'groupId': 'OG003'}, {'value': '-5.0', 'spread': '1.00', 'groupId': 'OG004'}, {'value': '-6.3', 'spread': '1.42', 'groupId': 'OG006'}, {'value': '-2.9', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-5.4', 'spread': '0.78', 'groupId': 'OG008'}, {'value': '-2.2', 'spread': '1.22', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-4.5', 'spread': '1.72', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '2.21', 'groupId': 'OG001'}, {'value': '-4.4', 'spread': '0.86', 'groupId': 'OG002'}, {'value': '-4.3', 'spread': '0.76', 'groupId': 'OG003'}, {'value': '-5.3', 'spread': '0.71', 'groupId': 'OG004'}, {'value': '-6.5', 'spread': '1.27', 'groupId': 'OG006'}, {'value': '-2.7', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-5.3', 'spread': '0.80', 'groupId': 'OG008'}, {'value': '-2.2', 'spread': '1.21', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-3.9', 'spread': '1.85', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '2.21', 'groupId': 'OG001'}, {'value': '-4.4', 'spread': '0.83', 'groupId': 'OG002'}, {'value': '-4.2', 'spread': '0.86', 'groupId': 'OG003'}, {'value': '-5.5', 'spread': '0.50', 'groupId': 'OG004'}, {'value': '-6.6', 'spread': '1.32', 'groupId': 'OG006'}, {'value': '-2.0', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-5.5', 'spread': '0.83', 'groupId': 'OG008'}, {'value': '-2.3', 'spread': '1.22', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-3.8', 'spread': '1.75', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '2.21', 'groupId': 'OG001'}, {'value': '-4.5', 'spread': '0.80', 'groupId': 'OG002'}, {'value': '-4.1', 'spread': '0.92', 'groupId': 'OG003'}, {'value': '-5.5', 'spread': '0.50', 'groupId': 'OG004'}, {'value': '-6.4', 'spread': '1.42', 'groupId': 'OG006'}, {'value': '-1.9', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-5.6', 'spread': '0.81', 'groupId': 'OG008'}, {'value': '-2.3', 'spread': '1.21', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-4.4', 'spread': '1.68', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '2.21', 'groupId': 'OG001'}, {'value': '-4.2', 'spread': '0.85', 'groupId': 'OG002'}, {'value': '-3.8', 'spread': '0.91', 'groupId': 'OG003'}, {'value': '-5.5', 'spread': '0.50', 'groupId': 'OG004'}, {'value': '-6.8', 'spread': '1.23', 'groupId': 'OG006'}, {'value': '-2.0', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-5.4', 'spread': '0.86', 'groupId': 'OG008'}, {'value': '-2.6', 'spread': '1.35', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-4.1', 'spread': '1.74', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '2.21', 'groupId': 'OG001'}, {'value': '-4.3', 'spread': '0.87', 'groupId': 'OG002'}, {'value': '-3.5', 'spread': '0.96', 'groupId': 'OG003'}, {'value': '-5.5', 'spread': '0.50', 'groupId': 'OG004'}, {'value': '-6.6', 'spread': '1.25', 'groupId': 'OG006'}, {'value': '-1.6', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-5.3', 'spread': '0.86', 'groupId': 'OG008'}, {'value': '-2.6', 'spread': '1.33', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-4.5', 'spread': '1.81', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '2.21', 'groupId': 'OG001'}, {'value': '-4.5', 'spread': '0.89', 'groupId': 'OG002'}, {'value': '-3.4', 'spread': '0.97', 'groupId': 'OG003'}, {'value': '-5.5', 'spread': '0.50', 'groupId': 'OG004'}, {'value': '-6.8', 'spread': '1.11', 'groupId': 'OG006'}, {'value': '-1.4', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-5.0', 'spread': '0.99', 'groupId': 'OG008'}, {'value': '-2.7', 'spread': '1.38', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-4.4', 'spread': '1.67', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '2.21', 'groupId': 'OG001'}, {'value': '-4.3', 'spread': '0.97', 'groupId': 'OG002'}, {'value': '-3.4', 'spread': '1.06', 'groupId': 'OG003'}, {'value': '-5.6', 'spread': '0.57', 'groupId': 'OG004'}, {'value': '-6.9', 'spread': '1.01', 'groupId': 'OG006'}, {'value': '-1.4', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-5.0', 'spread': '1.01', 'groupId': 'OG008'}, {'value': '-2.7', 'spread': '1.39', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 1-18', 'description': 'WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Weekly Average WI-NRS Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'KPL-716: CIU Cohort', 'description': 'Participants with CIU received KPL-716 weekly for 8 weeks'}, {'id': 'OG001', 'title': 'Placebo: CIU Cohort', 'description': 'Participants with CIU received placebo weekly for 8 weeks'}, {'id': 'OG002', 'title': 'KPL-716: CIP Cohort', 'description': 'Participants with CIP received KPL-716 weekly for 8 weeks'}, {'id': 'OG003', 'title': 'Placebo: CIP Cohort', 'description': 'Participants with CIP received placebo weekly for 8 weeks'}, {'id': 'OG004', 'title': 'KPL-716: LP Cohort', 'description': 'Participants with LP received KPL-716 weekly for 8 weeks'}, {'id': 'OG005', 'title': 'Placebo: LP Cohort', 'description': 'Participants with LP received placebo weekly for 8 weeks'}, {'id': 'OG006', 'title': 'KPL-716: LSC Cohort', 'description': 'Participants with LSC received KPL-716 weekly for 8 weeks'}, {'id': 'OG007', 'title': 'Placebo: LSC Cohort', 'description': 'Participants with LSC received placebo weekly for 8 weeks'}, {'id': 'OG008', 'title': 'KPL-716: PPs Cohort', 'description': 'Participants with PPs received KPL-716 weekly for 8 weeks'}, {'id': 'OG009', 'title': 'Placebo: PPs Cohort', 'description': 'Participants with PPs received placebo weekly for 8 weeks'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-23.5', 'spread': '8.22', 'groupId': 'OG000'}, {'value': '-16.2', 'spread': '11.84', 'groupId': 'OG001'}, {'value': '-19.5', 'spread': '6.57', 'groupId': 'OG002'}, {'value': '-18.3', 'spread': '8.20', 'groupId': 'OG003'}, {'value': '-2.4', 'spread': '2.19', 'groupId': 'OG004'}, {'value': '-44.2', 'spread': '12.54', 'groupId': 'OG006'}, {'value': '16.9', 'spread': '28.60', 'groupId': 'OG007'}, {'value': '-8.8', 'spread': '1.84', 'groupId': 'OG008'}, {'value': '-3.4', 'spread': '2.61', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-37.2', 'spread': '12.11', 'groupId': 'OG000'}, {'value': '-20.6', 'spread': '17.45', 'groupId': 'OG001'}, {'value': '-36.7', 'spread': '7.42', 'groupId': 'OG002'}, {'value': '-36.5', 'spread': '9.25', 'groupId': 'OG003'}, {'value': '-6.1', 'spread': '4.37', 'groupId': 'OG004'}, {'value': '-59.8', 'spread': '10.80', 'groupId': 'OG006'}, {'value': '29.3', 'spread': '24.62', 'groupId': 'OG007'}, {'value': '-17.8', 'spread': '3.16', 'groupId': 'OG008'}, {'value': '-8.4', 'spread': '4.46', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-46.9', 'spread': '18.33', 'groupId': 'OG000'}, {'value': '-25.0', 'spread': '26.41', 'groupId': 'OG001'}, {'value': '-43.4', 'spread': '7.37', 'groupId': 'OG002'}, {'value': '-31.5', 'spread': '9.19', 'groupId': 'OG003'}, {'value': '-15.0', 'spread': '8.02', 'groupId': 'OG004'}, {'value': '-67.9', 'spread': '12.89', 'groupId': 'OG006'}, {'value': '25.9', 'spread': '29.39', 'groupId': 'OG007'}, {'value': '-31.2', 'spread': '4.14', 'groupId': 'OG008'}, {'value': '-11.2', 'spread': '5.86', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-48.9', 'spread': '19.96', 'groupId': 'OG000'}, {'value': '-20.0', 'spread': '28.76', 'groupId': 'OG001'}, {'value': '-43.9', 'spread': '7.92', 'groupId': 'OG002'}, {'value': '-38.4', 'spread': '9.87', 'groupId': 'OG003'}, {'value': '-29.3', 'spread': '18.23', 'groupId': 'OG004'}, {'value': '-71.7', 'spread': '9.93', 'groupId': 'OG006'}, {'value': '8.0', 'spread': '22.65', 'groupId': 'OG007'}, {'value': '-41.7', 'spread': '5.63', 'groupId': 'OG008'}, {'value': '-14.5', 'spread': '7.96', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-54.7', 'spread': '23.35', 'groupId': 'OG000'}, {'value': '-22.0', 'spread': '33.65', 'groupId': 'OG001'}, {'value': '-51.6', 'spread': '8.70', 'groupId': 'OG002'}, {'value': '-40.6', 'spread': '10.84', 'groupId': 'OG003'}, {'value': '-31.1', 'spread': '20.41', 'groupId': 'OG004'}, {'value': '-76.9', 'spread': '13.08', 'groupId': 'OG006'}, {'value': '13.8', 'spread': '29.81', 'groupId': 'OG007'}, {'value': '-53.0', 'spread': '7.11', 'groupId': 'OG008'}, {'value': '-17.7', 'spread': '10.05', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-57.3', 'spread': '21.58', 'groupId': 'OG000'}, {'value': '-23.8', 'spread': '31.10', 'groupId': 'OG001'}, {'value': '-52.3', 'spread': '9.11', 'groupId': 'OG002'}, {'value': '-47.9', 'spread': '11.36', 'groupId': 'OG003'}, {'value': '-33.5', 'spread': '17.50', 'groupId': 'OG004'}, {'value': '-81.5', 'spread': '13.07', 'groupId': 'OG006'}, {'value': '7.0', 'spread': '29.80', 'groupId': 'OG007'}, {'value': '-56.5', 'spread': '6.88', 'groupId': 'OG008'}, {'value': '-18.7', 'spread': '9.72', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-53.6', 'spread': '24.07', 'groupId': 'OG000'}, {'value': '-36.4', 'spread': '34.67', 'groupId': 'OG001'}, {'value': '-54.3', 'spread': '8.98', 'groupId': 'OG002'}, {'value': '-48.1', 'spread': '11.19', 'groupId': 'OG003'}, {'value': '-39.4', 'spread': '10.21', 'groupId': 'OG004'}, {'value': '-87.4', 'spread': '11.02', 'groupId': 'OG006'}, {'value': '7.8', 'spread': '25.13', 'groupId': 'OG007'}, {'value': '-60.6', 'spread': '7.48', 'groupId': 'OG008'}, {'value': '-22.5', 'spread': '10.57', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-50.7', 'spread': '21.56', 'groupId': 'OG000'}, {'value': '-19.0', 'spread': '31.07', 'groupId': 'OG001'}, {'value': '-52.4', 'spread': '9.32', 'groupId': 'OG002'}, {'value': '-48.8', 'spread': '11.63', 'groupId': 'OG003'}, {'value': '-39.4', 'spread': '10.21', 'groupId': 'OG004'}, {'value': '-85.0', 'spread': '11.76', 'groupId': 'OG006'}, {'value': '7.0', 'spread': '26.80', 'groupId': 'OG007'}, {'value': '-66.5', 'spread': '7.78', 'groupId': 'OG008'}, {'value': '-29.0', 'spread': '11.00', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-51.1', 'spread': '19.68', 'groupId': 'OG000'}, {'value': '-19.0', 'spread': '28.35', 'groupId': 'OG001'}, {'value': '-55.7', 'spread': '9.95', 'groupId': 'OG002'}, {'value': '-48.6', 'spread': '11.50', 'groupId': 'OG003'}, {'value': '-62.5', 'spread': '12.50', 'groupId': 'OG004'}, {'value': '-85.2', 'spread': '14.00', 'groupId': 'OG006'}, {'value': '4.0', 'spread': '31.91', 'groupId': 'OG007'}, {'value': '-68.1', 'spread': '8.42', 'groupId': 'OG008'}, {'value': '-28.5', 'spread': '11.91', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-50.0', 'spread': '20.26', 'groupId': 'OG000'}, {'value': '-27.9', 'spread': '29.19', 'groupId': 'OG001'}, {'value': '-52.6', 'spread': '9.40', 'groupId': 'OG002'}, {'value': '-58.7', 'spread': '10.86', 'groupId': 'OG003'}, {'value': '-62.5', 'spread': '12.50', 'groupId': 'OG004'}, {'value': '-86.8', 'spread': '11.34', 'groupId': 'OG006'}, {'value': '-1.2', 'spread': '25.85', 'groupId': 'OG007'}, {'value': '-67.0', 'spread': '8.73', 'groupId': 'OG008'}, {'value': '-24.5', 'spread': '12.35', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-50.4', 'spread': '20.87', 'groupId': 'OG000'}, {'value': '-27.3', 'spread': '30.07', 'groupId': 'OG001'}, {'value': '-52.8', 'spread': '9.91', 'groupId': 'OG002'}, {'value': '-61.4', 'spread': '11.45', 'groupId': 'OG003'}, {'value': '-62.5', 'spread': '12.50', 'groupId': 'OG004'}, {'value': '-86.6', 'spread': '10.72', 'groupId': 'OG006'}, {'value': '-0.4', 'spread': '24.44', 'groupId': 'OG007'}, {'value': '-64.1', 'spread': '8.66', 'groupId': 'OG008'}, {'value': '-24.8', 'spread': '12.25', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-55.4', 'spread': '21.36', 'groupId': 'OG000'}, {'value': '-28.2', 'spread': '30.77', 'groupId': 'OG001'}, {'value': '-53.9', 'spread': '9.88', 'groupId': 'OG002'}, {'value': '-53.2', 'spread': '11.42', 'groupId': 'OG003'}, {'value': '-66.1', 'spread': '8.93', 'groupId': 'OG004'}, {'value': '-89.0', 'spread': '8.84', 'groupId': 'OG006'}, {'value': '-2.8', 'spread': '20.15', 'groupId': 'OG007'}, {'value': '-62.2', 'spread': '8.85', 'groupId': 'OG008'}, {'value': '-24.8', 'spread': '12.52', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-47.2', 'spread': '22.72', 'groupId': 'OG000'}, {'value': '-27.6', 'spread': '32.73', 'groupId': 'OG001'}, {'value': '-53.8', 'spread': '10.04', 'groupId': 'OG002'}, {'value': '-52.2', 'spread': '11.59', 'groupId': 'OG003'}, {'value': '-68.8', 'spread': '6.25', 'groupId': 'OG004'}, {'value': '-90.1', 'spread': '10.04', 'groupId': 'OG006'}, {'value': '6.1', 'spread': '22.89', 'groupId': 'OG007'}, {'value': '-64.9', 'spread': '9.22', 'groupId': 'OG008'}, {'value': '-25.2', 'spread': '13.03', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-46.8', 'spread': '20.94', 'groupId': 'OG000'}, {'value': '-27.7', 'spread': '30.17', 'groupId': 'OG001'}, {'value': '-55.3', 'spread': '10.15', 'groupId': 'OG002'}, {'value': '-51.4', 'spread': '11.72', 'groupId': 'OG003'}, {'value': '-68.8', 'spread': '6.25', 'groupId': 'OG004'}, {'value': '-88.8', 'spread': '10.85', 'groupId': 'OG006'}, {'value': '10.7', 'spread': '24.74', 'groupId': 'OG007'}, {'value': '-65.9', 'spread': '9.17', 'groupId': 'OG008'}, {'value': '-26.1', 'spread': '12.97', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-53.6', 'spread': '20.68', 'groupId': 'OG000'}, {'value': '-28.2', 'spread': '29.79', 'groupId': 'OG001'}, {'value': '-50.8', 'spread': '10.54', 'groupId': 'OG002'}, {'value': '-49.0', 'spread': '12.18', 'groupId': 'OG003'}, {'value': '-68.8', 'spread': '6.25', 'groupId': 'OG004'}, {'value': '-91.8', 'spread': '9.58', 'groupId': 'OG006'}, {'value': '3.0', 'spread': '21.85', 'groupId': 'OG007'}, {'value': '-63.7', 'spread': '9.87', 'groupId': 'OG008'}, {'value': '-29.5', 'spread': '13.96', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-50.0', 'spread': '21.31', 'groupId': 'OG000'}, {'value': '-28.0', 'spread': '30.70', 'groupId': 'OG001'}, {'value': '-51.7', 'spread': '10.86', 'groupId': 'OG002'}, {'value': '-44.7', 'spread': '12.54', 'groupId': 'OG003'}, {'value': '-68.8', 'spread': '6.25', 'groupId': 'OG004'}, {'value': '-90.6', 'spread': '9.28', 'groupId': 'OG006'}, {'value': '9.1', 'spread': '21.17', 'groupId': 'OG007'}, {'value': '-62.7', 'spread': '9.81', 'groupId': 'OG008'}, {'value': '-29.3', 'spread': '13.88', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-55.0', 'spread': '23.07', 'groupId': 'OG000'}, {'value': '-28.7', 'spread': '33.24', 'groupId': 'OG001'}, {'value': '-54.2', 'spread': '11.00', 'groupId': 'OG002'}, {'value': '-43.7', 'spread': '12.70', 'groupId': 'OG003'}, {'value': '-68.8', 'spread': '6.25', 'groupId': 'OG004'}, {'value': '-92.2', 'spread': '8.10', 'groupId': 'OG006'}, {'value': '6.8', 'spread': '18.46', 'groupId': 'OG007'}, {'value': '-58.0', 'spread': '11.35', 'groupId': 'OG008'}, {'value': '-30.8', 'spread': '16.05', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-54.5', 'spread': '20.93', 'groupId': 'OG000'}, {'value': '-28.9', 'spread': '30.15', 'groupId': 'OG001'}, {'value': '-51.5', 'spread': '12.05', 'groupId': 'OG002'}, {'value': '-43.7', 'spread': '13.92', 'groupId': 'OG003'}, {'value': '-69.6', 'spread': '7.14', 'groupId': 'OG004'}, {'value': '-92.1', 'spread': '6.42', 'groupId': 'OG006'}, {'value': '4.1', 'spread': '14.63', 'groupId': 'OG007'}, {'value': '-58.1', 'spread': '11.43', 'groupId': 'OG008'}, {'value': '-31.1', 'spread': '16.17', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '0.6533', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-7.3', 'ciLowerLimit': '-31.52', 'ciUpperLimit': '16.84', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '14.76', 'groupDescription': 'Change at Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9077', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-1.2', 'ciLowerLimit': '-15.16', 'ciUpperLimit': '12.69', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.51', 'groupDescription': 'Change at Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2065', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-61.2', 'ciLowerLimit': '-123.73', 'ciUpperLimit': '1.39', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '33.18', 'groupDescription': 'Change at Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1133', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-5.3', 'ciLowerLimit': '-9.56', 'ciUpperLimit': '-1.07', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.19', 'groupDescription': 'Change at Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4997', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-16.7', 'ciLowerLimit': '-52.29', 'ciUpperLimit': '18.98', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '21.76', 'groupDescription': 'Change at Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9919', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.1', 'ciLowerLimit': '-15.83', 'ciUpperLimit': '15.59', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.85', 'groupDescription': 'Change at Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0891', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-89.2', 'ciLowerLimit': '-143.03', 'ciUpperLimit': '-35.31', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '28.56', 'groupDescription': 'Change at Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1029', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-9.4', 'ciLowerLimit': '-16.67', 'ciUpperLimit': '-2.12', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.47', 'groupDescription': 'Change at Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5538', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-21.9', 'ciLowerLimit': '-75.82', 'ciUpperLimit': '32.05', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '32.93', 'groupDescription': 'Change at Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3252', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-11.9', 'ciLowerLimit': '-27.51', 'ciUpperLimit': '3.73', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.78', 'groupDescription': 'Change at Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1106', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-93.8', 'ciLowerLimit': '-158.11', 'ciUpperLimit': '-29.52', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '34.10', 'groupDescription': 'Change at Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0123', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-19.9', 'ciLowerLimit': '-29.48', 'ciUpperLimit': '-10.40', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.17', 'groupDescription': 'Change at Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4791', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-28.9', 'ciLowerLimit': '-87.63', 'ciUpperLimit': '29.81', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '35.86', 'groupDescription': 'Change at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6684', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-5.5', 'ciLowerLimit': '-22.28', 'ciUpperLimit': '11.27', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.66', 'groupDescription': 'Change at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0937', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-79.7', 'ciLowerLimit': '-129.22', 'ciUpperLimit': '-30.13', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '26.28', 'groupDescription': 'Change at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0120', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-27.2', 'ciLowerLimit': '-40.21', 'ciUpperLimit': '-14.27', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.75', 'groupDescription': 'Change at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4927', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-32.7', 'ciLowerLimit': '-101.39', 'ciUpperLimit': '36.02', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '41.95', 'groupDescription': 'Change at Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4409', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-10.9', 'ciLowerLimit': '-29.35', 'ciUpperLimit': '7.49', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.90', 'groupDescription': 'Change at Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1197', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-90.7', 'ciLowerLimit': '-155.96', 'ciUpperLimit': '-25.54', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '34.58', 'groupDescription': 'Change at Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0102', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-35.3', 'ciLowerLimit': '-51.68', 'ciUpperLimit': '-18.92', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.31', 'groupDescription': 'Change at Week 5', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4515', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-33.5', 'ciLowerLimit': '-96.97', 'ciUpperLimit': '30.02', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '38.77', 'groupDescription': 'Change at Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7623', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-4.5', 'ciLowerLimit': '-23.76', 'ciUpperLimit': '14.83', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '14.56', 'groupDescription': 'Change at Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1247', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-88.5', 'ciLowerLimit': '-153.65', 'ciUpperLimit': '-23.29', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '34.57', 'groupDescription': 'Change at Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0053', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-37.7', 'ciLowerLimit': '-53.59', 'ciUpperLimit': '-21.90', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.91', 'groupDescription': 'Change at Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7177', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-17.2', 'ciLowerLimit': '-87.97', 'ciUpperLimit': '53.62', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '43.23', 'groupDescription': 'Change at Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6682', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-6.2', 'ciLowerLimit': '-25.26', 'ciUpperLimit': '12.78', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '14.35', 'groupDescription': 'Change at Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0823', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-95.2', 'ciLowerLimit': '-150.21', 'ciUpperLimit': '-40.24', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '29.16', 'groupDescription': 'Change at Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0087', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-38.1', 'ciLowerLimit': '-55.38', 'ciUpperLimit': '-20.92', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.95', 'groupDescription': 'Change at Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4734', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-31.7', 'ciLowerLimit': '-95.11', 'ciUpperLimit': '31.76', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '38.73', 'groupDescription': 'Change at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8130', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-3.6', 'ciLowerLimit': '-23.33', 'ciUpperLimit': '16.18', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '14.91', 'groupDescription': 'Change at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0979', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-92.0', 'ciLowerLimit': '-150.60', 'ciUpperLimit': '-33.32', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '31.10', 'groupDescription': 'Change at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0122', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-37.5', 'ciLowerLimit': '-55.48', 'ciUpperLimit': '-19.61', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.48', 'groupDescription': 'Change at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4310', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-32.1', 'ciLowerLimit': '-89.98', 'ciUpperLimit': '25.81', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '35.35', 'groupDescription': 'Change at Week 9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6452', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-7.1', 'ciLowerLimit': '-27.38', 'ciUpperLimit': '13.12', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '15.22', 'groupDescription': 'Change at Week 9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1375', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-89.2', 'ciLowerLimit': '-159.04', 'ciUpperLimit': '-19.44', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '37.02', 'groupDescription': 'Change at Week 9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0143', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-39.6', 'ciLowerLimit': '-58.97', 'ciUpperLimit': '-20.15', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '14.59', 'groupDescription': 'Change at Week 9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5867', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-22.1', 'ciLowerLimit': '-81.70', 'ciUpperLimit': '37.52', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '36.40', 'groupDescription': 'Change at Week 10', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6745', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '6.1', 'ciLowerLimit': '-12.99', 'ciUpperLimit': '25.27', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '14.38', 'groupDescription': 'Change at Week 10', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1039', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-85.6', 'ciLowerLimit': '-142.18', 'ciUpperLimit': '-29.09', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '29.99', 'groupDescription': 'Change at Week 10', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0116', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-42.5', 'ciLowerLimit': '-62.60', 'ciUpperLimit': '-22.36', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '15.12', 'groupDescription': 'Change at Week 10', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5807', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-23.1', 'ciLowerLimit': '-84.55', 'ciUpperLimit': '38.26', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '37.49', 'groupDescription': 'Change at Week 11', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5765', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '8.6', 'ciLowerLimit': '-11.55', 'ciUpperLimit': '28.80', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '15.16', 'groupDescription': 'Change at Week 11', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0933', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-86.2', 'ciLowerLimit': '-139.70', 'ciUpperLimit': '-32.75', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '28.36', 'groupDescription': 'Change at Week 11', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0173', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-39.3', 'ciLowerLimit': '-59.29', 'ciUpperLimit': '-19.37', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'groupDescription': 'Change at Week 11', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5293', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-27.2', 'ciLowerLimit': '-90.04', 'ciUpperLimit': '35.62', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '38.36', 'groupDescription': 'Change at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9676', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.6', 'ciLowerLimit': '-20.73', 'ciUpperLimit': '19.49', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '15.12', 'groupDescription': 'Change at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0663', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-86.2', 'ciLowerLimit': '-130.27', 'ciUpperLimit': '-42.11', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '23.38', 'groupDescription': 'Change at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0252', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-37.4', 'ciLowerLimit': '-57.81', 'ciUpperLimit': '-17.02', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '15.33', 'groupDescription': 'Change at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6637', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-19.6', 'ciLowerLimit': '-86.45', 'ciUpperLimit': '47.22', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '40.81', 'groupDescription': 'Change at Week 13', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9173', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-1.6', 'ciLowerLimit': '-22.04', 'ciUpperLimit': '18.81', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '15.35', 'groupDescription': 'Change at Week 13', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0685', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-96.2', 'ciLowerLimit': '-146.23', 'ciUpperLimit': '-46.10', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '26.55', 'groupDescription': 'Change at Week 13', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0230', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-39.7', 'ciLowerLimit': '-60.91', 'ciUpperLimit': '-18.44', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '15.96', 'groupDescription': 'Change at Week 13', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6471', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-19.1', 'ciLowerLimit': '-80.69', 'ciUpperLimit': '42.54', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '37.62', 'groupDescription': 'Change at Week 14', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8044', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-3.9', 'ciLowerLimit': '-24.56', 'ciUpperLimit': '16.75', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '15.52', 'groupDescription': 'Change at Week 14', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0741', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-99.5', 'ciLowerLimit': '-153.63', 'ciUpperLimit': '-45.37', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '28.71', 'groupDescription': 'Change at Week 14', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0219', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-39.9', 'ciLowerLimit': '-61.00', 'ciUpperLimit': '-18.72', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '15.89', 'groupDescription': 'Change at Week 14', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5436', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-25.4', 'ciLowerLimit': '-86.21', 'ciUpperLimit': '35.46', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '37.15', 'groupDescription': 'Change at Week 15', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9149', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-1.7', 'ciLowerLimit': '-23.20', 'ciUpperLimit': '19.71', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '16.13', 'groupDescription': 'Change at Week 15', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0646', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-94.8', 'ciLowerLimit': '-142.63', 'ciUpperLimit': '-47.05', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '25.34', 'groupDescription': 'Change at Week 15', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0611', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-34.2', 'ciLowerLimit': '-56.89', 'ciUpperLimit': '-11.41', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '17.09', 'groupDescription': 'Change at Week 15', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6060', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-22.0', 'ciLowerLimit': '-84.68', 'ciUpperLimit': '40.71', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '38.28', 'groupDescription': 'Change at Week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6823', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-6.9', 'ciLowerLimit': '-29.00', 'ciUpperLimit': '15.18', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '16.61', 'groupDescription': 'Change at Week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0556', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-99.7', 'ciLowerLimit': '-146.02', 'ciUpperLimit': '-53.41', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '24.56', 'groupDescription': 'Change at Week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0652', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-33.4', 'ciLowerLimit': '-55.98', 'ciUpperLimit': '-10.76', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '16.99', 'groupDescription': 'Change at Week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5714', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-26.3', 'ciLowerLimit': '-94.14', 'ciUpperLimit': '41.62', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '41.45', 'groupDescription': 'Change at Week 17', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5386', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-10.5', 'ciLowerLimit': '-32.93', 'ciUpperLimit': '11.83', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '16.82', 'groupDescription': 'Change at Week 17', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0438', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-99.0', 'ciLowerLimit': '-139.35', 'ciUpperLimit': '-58.60', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '21.41', 'groupDescription': 'Change at Week 17', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1829', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-27.2', 'ciLowerLimit': '-53.38', 'ciUpperLimit': '-1.08', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '19.66', 'groupDescription': 'Change at Week 17', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.5443', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-25.6', 'ciLowerLimit': '-87.20', 'ciUpperLimit': '35.94', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '37.59', 'groupDescription': 'Change at Week 18', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6748', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-7.9', 'ciLowerLimit': '-32.39', 'ciUpperLimit': '16.66', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '18.43', 'groupDescription': 'Change at Week 18', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0297', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-96.2', 'ciLowerLimit': '-128.19', 'ciUpperLimit': '-64.19', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '16.97', 'groupDescription': 'Change at Week 18', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1899', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-27.0', 'ciLowerLimit': '-53.33', 'ciUpperLimit': '-0.63', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '19.80', 'groupDescription': 'Change at Week 18', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 1-18', 'description': 'WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'KPL-716: CIU Cohort', 'description': 'Participants with CIU received KPL-716 weekly for 8 weeks'}, {'id': 'OG001', 'title': 'Placebo: CIU Cohort', 'description': 'Participants with CIU received placebo weekly for 8 weeks'}, {'id': 'OG002', 'title': 'KPL-716: CIP Cohort', 'description': 'Participants with CIP received KPL-716 weekly for 8 weeks'}, {'id': 'OG003', 'title': 'Placebo: CIP Cohort', 'description': 'Participants with CIP received placebo weekly for 8 weeks'}, {'id': 'OG004', 'title': 'KPL-716: LP Cohort', 'description': 'Participants with LP received KPL-716 weekly for 8 weeks'}, {'id': 'OG005', 'title': 'Placebo: LP Cohort', 'description': 'Participants with LP received placebo weekly for 8 weeks'}, {'id': 'OG006', 'title': 'KPL-716: LSC Cohort', 'description': 'Participants with LSC received KPL-716 weekly for 8 weeks'}, {'id': 'OG007', 'title': 'Placebo: LSC Cohort', 'description': 'Participants with LSC received placebo weekly for 8 weeks'}, {'id': 'OG008', 'title': 'KPL-716: PPs Cohort', 'description': 'Participants with PPs received KPL-716 weekly for 8 weeks'}, {'id': 'OG009', 'title': 'Placebo: PPs Cohort', 'description': 'Participants with PPs received placebo weekly for 8 weeks'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '0.79', 'groupId': 'OG002'}, {'value': '-2.0', 'spread': '0.78', 'groupId': 'OG003'}, {'value': '-0.4', 'spread': '0.26', 'groupId': 'OG004'}, {'value': '-4.0', 'spread': '1.61', 'groupId': 'OG006'}, {'value': '-0.7', 'spread': 'NA', 'comment': '1 participant in this cohort', 'groupId': 'OG007'}, {'value': '-1.3', 'spread': '0.29', 'groupId': 'OG008'}, {'value': '-0.3', 'spread': '0.28', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '1.43', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '-3.0', 'spread': '0.96', 'groupId': 'OG002'}, {'value': '-2.6', 'spread': '0.62', 'groupId': 'OG003'}, {'value': '-0.4', 'spread': '0.19', 'groupId': 'OG004'}, {'value': '-4.4', 'spread': '1.80', 'groupId': 'OG006'}, {'value': '-1.0', 'spread': 'NA', 'comment': '1 participant in this cohort', 'groupId': 'OG007'}, {'value': '-2.2', 'spread': '0.55', 'groupId': 'OG008'}, {'value': '-0.7', 'spread': '0.31', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.10', 'groupId': 'OG001'}, {'value': '-3.2', 'spread': '1.09', 'groupId': 'OG002'}, {'value': '-3.4', 'spread': '0.97', 'groupId': 'OG003'}, {'value': '-2.0', 'spread': '1.36', 'groupId': 'OG004'}, {'value': '-5.2', 'spread': '1.85', 'groupId': 'OG006'}, {'value': '-2.2', 'spread': 'NA', 'comment': '1 participant in this cohort', 'groupId': 'OG007'}, {'value': '-3.4', 'spread': '0.55', 'groupId': 'OG008'}, {'value': '-0.9', 'spread': '0.81', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-4.3', 'spread': '1.67', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '-3.7', 'spread': '0.94', 'groupId': 'OG002'}, {'value': '-3.9', 'spread': '0.95', 'groupId': 'OG003'}, {'value': '-2.8', 'spread': '1.88', 'groupId': 'OG004'}, {'value': '-5.3', 'spread': '1.66', 'groupId': 'OG006'}, {'value': '-2.2', 'spread': 'NA', 'comment': '1 participant in this cohort', 'groupId': 'OG007'}, {'value': '-4.3', 'spread': '0.54', 'groupId': 'OG008'}, {'value': '-1.4', 'spread': '0.94', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-5.2', 'spread': '1.82', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '-4.5', 'spread': '1.01', 'groupId': 'OG002'}, {'value': '-4.7', 'spread': '0.88', 'groupId': 'OG003'}, {'value': '-3.0', 'spread': '1.86', 'groupId': 'OG004'}, {'value': '-5.7', 'spread': '1.67', 'groupId': 'OG006'}, {'value': '-3.7', 'spread': 'NA', 'comment': '1 participant in this cohort', 'groupId': 'OG007'}, {'value': '-4.3', 'spread': '0.51', 'groupId': 'OG008'}, {'value': '-1.6', 'spread': '0.99', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-4.4', 'spread': '1.88', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '-4.5', 'spread': '1.00', 'groupId': 'OG002'}, {'value': '-4.2', 'spread': '1.07', 'groupId': 'OG003'}, {'value': '-3.1', 'spread': '1.85', 'groupId': 'OG004'}, {'value': '-5.9', 'spread': '1.57', 'groupId': 'OG006'}, {'value': '-2.0', 'spread': 'NA', 'comment': '1 participant in this cohort', 'groupId': 'OG007'}, {'value': '-5.2', 'spread': '0.54', 'groupId': 'OG008'}, {'value': '-1.9', 'spread': '1.05', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-5.1', 'spread': '1.78', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.10', 'groupId': 'OG001'}, {'value': '-4.7', 'spread': '1.05', 'groupId': 'OG002'}, {'value': '-4.7', 'spread': '0.88', 'groupId': 'OG003'}, {'value': '-3.3', 'spread': '1.85', 'groupId': 'OG004'}, {'value': '-6.1', 'spread': '1.45', 'groupId': 'OG006'}, {'value': '-1.4', 'spread': 'NA', 'comment': '1 participant in this cohort', 'groupId': 'OG007'}, {'value': '-5.3', 'spread': '0.57', 'groupId': 'OG008'}, {'value': '-2.1', 'spread': '1.27', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-4.2', 'spread': '2.00', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '-4.4', 'spread': '1.03', 'groupId': 'OG002'}, {'value': '-4.3', 'spread': '0.95', 'groupId': 'OG003'}, {'value': '-3.3', 'spread': '1.85', 'groupId': 'OG004'}, {'value': '-6.0', 'spread': '1.42', 'groupId': 'OG006'}, {'value': '-1.8', 'spread': 'NA', 'comment': '1 participant in this cohort', 'groupId': 'OG007'}, {'value': '-5.8', 'spread': '0.61', 'groupId': 'OG008'}, {'value': '-2.2', 'spread': '1.29', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-4.8', 'spread': '1.86', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '-4.2', 'spread': '1.07', 'groupId': 'OG002'}, {'value': '-5.8', 'spread': '0.58', 'groupId': 'OG003'}, {'value': '-5.6', 'spread': '0.85', 'groupId': 'OG004'}, {'value': '-6.2', 'spread': '1.50', 'groupId': 'OG006'}, {'value': '-3.5', 'spread': 'NA', 'comment': '1 participant in this cohort', 'groupId': 'OG007'}, {'value': '-5.9', 'spread': '0.66', 'groupId': 'OG008'}, {'value': '-3.1', 'spread': '1.36', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-4.1', 'spread': '2.11', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '-4.7', 'spread': '1.10', 'groupId': 'OG002'}, {'value': '-4.8', 'spread': '1.18', 'groupId': 'OG003'}, {'value': '-5.1', 'spread': '1.30', 'groupId': 'OG004'}, {'value': '-6.3', 'spread': '1.37', 'groupId': 'OG006'}, {'value': '-3.5', 'spread': 'NA', 'comment': '1 participant in this cohort', 'groupId': 'OG007'}, {'value': '-5.6', 'spread': '0.71', 'groupId': 'OG008'}, {'value': '-3.8', 'spread': '1.26', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-3.5', 'spread': '2.19', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '-5.0', 'spread': '1.00', 'groupId': 'OG002'}, {'value': '-4.2', 'spread': '1.06', 'groupId': 'OG003'}, {'value': '-5.3', 'spread': '1.10', 'groupId': 'OG004'}, {'value': '-6.4', 'spread': '1.31', 'groupId': 'OG006'}, {'value': '-1.4', 'spread': 'NA', 'comment': '1 participant in this cohort', 'groupId': 'OG007'}, {'value': '-5.8', 'spread': '0.75', 'groupId': 'OG008'}, {'value': '-3.6', 'spread': '1.37', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-4.5', 'spread': '1.91', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '-4.2', 'spread': '1.07', 'groupId': 'OG002'}, {'value': '-4.0', 'spread': '1.13', 'groupId': 'OG003'}, {'value': '-5.6', 'spread': '0.85', 'groupId': 'OG004'}, {'value': '-6.6', 'spread': '1.12', 'groupId': 'OG006'}, {'value': '-0.8', 'spread': 'NA', 'comment': '1 participant in this cohort', 'groupId': 'OG007'}, {'value': '-5.6', 'spread': '0.79', 'groupId': 'OG008'}, {'value': '-3.5', 'spread': '1.41', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-3.9', 'spread': '2.07', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '-4.2', 'spread': '1.22', 'groupId': 'OG002'}, {'value': '-3.6', 'spread': '1.20', 'groupId': 'OG003'}, {'value': '-5.6', 'spread': '2.40', 'groupId': 'OG004'}, {'value': '-7.0', 'spread': '0.74', 'groupId': 'OG006'}, {'value': '-0.9', 'spread': 'NA', 'comment': '1 participant in this cohort', 'groupId': 'OG007'}, {'value': '-5.4', 'spread': '0.90', 'groupId': 'OG008'}, {'value': '-3.9', 'spread': '1.31', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 1-8, 10, 12, 14, 16, 18', 'description': 'Participants were asked to place a line perpendicular to the VAS line at the point that represents the intensity of their average pruritus experienced over the previous 3 days using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Pruritus VAS Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'KPL-716: CIU Cohort', 'description': 'Participants with CIU received KPL-716 weekly for 8 weeks'}, {'id': 'OG001', 'title': 'Placebo: CIU Cohort', 'description': 'Participants with CIU received placebo weekly for 8 weeks'}, {'id': 'OG002', 'title': 'KPL-716: CIP Cohort', 'description': 'Participants with CIP received KPL-716 weekly for 8 weeks'}, {'id': 'OG003', 'title': 'Placebo: CIP Cohort', 'description': 'Participants with CIP received placebo weekly for 8 weeks'}, {'id': 'OG004', 'title': 'KPL-716: LP Cohort', 'description': 'Participants with LP received KPL-716 weekly for 8 weeks'}, {'id': 'OG005', 'title': 'Placebo: LP Cohort', 'description': 'Participants with LP received placebo weekly for 8 weeks'}, {'id': 'OG006', 'title': 'KPL-716: LSC Cohort', 'description': 'Participants with LSC received KPL-716 weekly for 8 weeks'}, {'id': 'OG007', 'title': 'Placebo: LSC Cohort', 'description': 'Participants with LSC received placebo weekly for 8 weeks'}, {'id': 'OG008', 'title': 'KPL-716: PPs Cohort', 'description': 'Participants with PPs received KPL-716 weekly for 8 weeks'}, {'id': 'OG009', 'title': 'Placebo: PPs Cohort', 'description': 'Participants with PPs received placebo weekly for 8 weeks'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-23.6', 'spread': '13.76', 'groupId': 'OG000'}, {'value': '-8.3', 'spread': '19.72', 'groupId': 'OG001'}, {'value': '-15.3', 'spread': '9.17', 'groupId': 'OG002'}, {'value': '-24.8', 'spread': '11.44', 'groupId': 'OG003'}, {'value': '-5.3', 'spread': '1.80', 'groupId': 'OG004'}, {'value': '-76.1', 'spread': '27.14', 'groupId': 'OG006'}, {'value': '90.9', 'spread': '85.95', 'groupId': 'OG007'}, {'value': '-15.4', 'spread': '3.19', 'groupId': 'OG008'}, {'value': '-4.6', 'spread': '4.52', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-37.4', 'spread': '19.67', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '28.19', 'groupId': 'OG001'}, {'value': '-34.2', 'spread': '9.66', 'groupId': 'OG002'}, {'value': '-32.8', 'spread': '12.04', 'groupId': 'OG003'}, {'value': '-5.1', 'spread': '3.22', 'groupId': 'OG004'}, {'value': '-79.6', 'spread': '34.28', 'groupId': 'OG006'}, {'value': '81.3', 'spread': '108.56', 'groupId': 'OG007'}, {'value': '-24.2', 'spread': '5.50', 'groupId': 'OG008'}, {'value': '-10.1', 'spread': '7.78', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-43.3', 'spread': '19.79', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '28.36', 'groupId': 'OG001'}, {'value': '-37.4', 'spread': '12.12', 'groupId': 'OG002'}, {'value': '-44.5', 'spread': '15.12', 'groupId': 'OG003'}, {'value': '-26.2', 'spread': '8.32', 'groupId': 'OG004'}, {'value': '-97.1', 'spread': '28.92', 'groupId': 'OG006'}, {'value': '96.7', 'spread': '91.57', 'groupId': 'OG007'}, {'value': '-40.6', 'spread': '6.26', 'groupId': 'OG008'}, {'value': '-10.3', 'spread': '8.87', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-54.9', 'spread': '19.93', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '28.57', 'groupId': 'OG001'}, {'value': '-44.4', 'spread': '10.57', 'groupId': 'OG002'}, {'value': '-50.7', 'spread': '13.18', 'groupId': 'OG003'}, {'value': '-37.3', 'spread': '12.60', 'groupId': 'OG004'}, {'value': '-93.6', 'spread': '28.13', 'groupId': 'OG006'}, {'value': '74.8', 'spread': '89.08', 'groupId': 'OG007'}, {'value': '-52.7', 'spread': '6.55', 'groupId': 'OG008'}, {'value': '-16.0', 'spread': '9.27', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-66.3', 'spread': '21.37', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '30.63', 'groupId': 'OG001'}, {'value': '-54.1', 'spread': '10.84', 'groupId': 'OG002'}, {'value': '-60.4', 'spread': '13.52', 'groupId': 'OG003'}, {'value': '-40.0', 'spread': '15.97', 'groupId': 'OG004'}, {'value': '-99.4', 'spread': '26.68', 'groupId': 'OG006'}, {'value': '64.0', 'spread': '84.47', 'groupId': 'OG007'}, {'value': '-52.5', 'spread': '6.54', 'groupId': 'OG008'}, {'value': '-19.1', 'spread': '9.26', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-57.2', 'spread': '22.58', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '32.37', 'groupId': 'OG001'}, {'value': '-53.0', 'spread': '11.31', 'groupId': 'OG002'}, {'value': '-52.4', 'spread': '14.11', 'groupId': 'OG003'}, {'value': '-41.6', 'spread': '17.99', 'groupId': 'OG004'}, {'value': '-101.0', 'spread': '24.68', 'groupId': 'OG006'}, {'value': '76.3', 'spread': '78.14', 'groupId': 'OG007'}, {'value': '-63.5', 'spread': '6.90', 'groupId': 'OG008'}, {'value': '-21.5', 'spread': '9.77', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-65.7', 'spread': '18.99', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '27.22', 'groupId': 'OG001'}, {'value': '-55.7', 'spread': '10.97', 'groupId': 'OG002'}, {'value': '-60.8', 'spread': '13.68', 'groupId': 'OG003'}, {'value': '-44.3', 'spread': '21.36', 'groupId': 'OG004'}, {'value': '-101.8', 'spread': '22.55', 'groupId': 'OG006'}, {'value': '73.6', 'spread': '71.40', 'groupId': 'OG007'}, {'value': '-64.6', 'spread': '7.89', 'groupId': 'OG008'}, {'value': '-25.4', 'spread': '11.18', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-54.1', 'spread': '22.59', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '32.38', 'groupId': 'OG001'}, {'value': '-52.1', 'spread': '11.11', 'groupId': 'OG002'}, {'value': '-55.0', 'spread': '13.86', 'groupId': 'OG003'}, {'value': '-44.3', 'spread': '21.36', 'groupId': 'OG004'}, {'value': '-99.2', 'spread': '23.11', 'groupId': 'OG006'}, {'value': '63.8', 'spread': '73.18', 'groupId': 'OG007'}, {'value': '-70.9', 'spread': '8.44', 'groupId': 'OG008'}, {'value': '-25.2', 'spread': '11.96', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-61.6', 'spread': '20.31', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '29.11', 'groupId': 'OG001'}, {'value': '-50.7', 'spread': '10.73', 'groupId': 'OG002'}, {'value': '-72.2', 'spread': '12.39', 'groupId': 'OG003'}, {'value': '-76.9', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-103.9', 'spread': '22.62', 'groupId': 'OG006'}, {'value': '57.5', 'spread': '71.64', 'groupId': 'OG007'}, {'value': '-70.6', 'spread': '8.32', 'groupId': 'OG008'}, {'value': '-36.2', 'spread': '12.71', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-51.9', 'spread': '21.21', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '30.40', 'groupId': 'OG001'}, {'value': '-56.3', 'spread': '12.44', 'groupId': 'OG002'}, {'value': '-58.7', 'spread': '14.37', 'groupId': 'OG003'}, {'value': '-69.7', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-102.9', 'spread': '21.13', 'groupId': 'OG006'}, {'value': '46.3', 'spread': '66.92', 'groupId': 'OG007'}, {'value': '-67.6', 'spread': '8.32', 'groupId': 'OG008'}, {'value': '-45.5', 'spread': '12.71', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-44.2', 'spread': '20.40', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '29.24', 'groupId': 'OG001'}, {'value': '-60.8', 'spread': '11.32', 'groupId': 'OG002'}, {'value': '-51.2', 'spread': '13.07', 'groupId': 'OG003'}, {'value': '-72.9', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-103.3', 'spread': '19.74', 'groupId': 'OG006'}, {'value': '64.5', 'spread': '62.52', 'groupId': 'OG007'}, {'value': '-69.6', 'spread': '8.91', 'groupId': 'OG008'}, {'value': '-42.5', 'spread': '13.61', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-56.8', 'spread': '14.02', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '20.09', 'groupId': 'OG001'}, {'value': '-49.5', 'spread': '11.91', 'groupId': 'OG002'}, {'value': '-48.9', 'spread': '13.75', 'groupId': 'OG003'}, {'value': '-76.9', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-102.0', 'spread': '16.87', 'groupId': 'OG006'}, {'value': '57.2', 'spread': '53.41', 'groupId': 'OG007'}, {'value': '-68.1', 'spread': '9.43', 'groupId': 'OG008'}, {'value': '-41.6', 'spread': '14.40', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-47.8', 'spread': '14.97', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '21.45', 'groupId': 'OG001'}, {'value': '-49.1', 'spread': '13.66', 'groupId': 'OG002'}, {'value': '-45.0', 'spread': '15.77', 'groupId': 'OG003'}, {'value': '-74.6', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-101.3', 'spread': '9.93', 'groupId': 'OG006'}, {'value': '29.5', 'spread': '31.43', 'groupId': 'OG007'}, {'value': '-64.5', 'spread': '10.23', 'groupId': 'OG008'}, {'value': '-46.0', 'spread': '15.63', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '0.5763', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-15.3', 'ciLowerLimit': '-55.37', 'ciUpperLimit': '24.78', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '24.47', 'groupDescription': 'Change at Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5214', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '9.6', 'ciLowerLimit': '-9.86', 'ciUpperLimit': '29.01', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '14.66', 'groupDescription': 'Change at Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2536', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-167.0', 'ciLowerLimit': '-365.51', 'ciUpperLimit': '31.54', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '105.28', 'groupDescription': 'Change at Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0670', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-10.8', 'ciLowerLimit': '-18.20', 'ciUpperLimit': '-3.44', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.55', 'groupDescription': 'Change at Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4133', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-33.1', 'ciLowerLimit': '-90.43', 'ciUpperLimit': '24.15', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '34.98', 'groupDescription': 'Change at Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9305', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-1.4', 'ciLowerLimit': '-21.83', 'ciUpperLimit': '19.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '15.44', 'groupDescription': 'Change at Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3499', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-160.9', 'ciLowerLimit': '-411.65', 'ciUpperLimit': '89.86', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '132.98', 'groupDescription': 'Change at Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1588', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-14.0', 'ciLowerLimit': '-26.74', 'ciUpperLimit': '-1.33', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.55', 'groupDescription': 'Change at Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3319', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-40.6', 'ciLowerLimit': '-98.26', 'ciUpperLimit': '17.00', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '35.19', 'groupDescription': 'Change at Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7179', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '7.1', 'ciLowerLimit': '-18.59', 'ciUpperLimit': '32.80', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '19.39', 'groupDescription': 'Change at Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2261', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-193.8', 'ciLowerLimit': '-405.34', 'ciUpperLimit': '17.67', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '112.17', 'groupDescription': 'Change at Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0123', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-30.3', 'ciLowerLimit': '-44.75', 'ciUpperLimit': '-15.80', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.88', 'groupDescription': 'Change at Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2253', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-54.0', 'ciLowerLimit': '-112.02', 'ciUpperLimit': '4.09', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '35.45', 'groupDescription': 'Change at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7149', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '6.3', 'ciLowerLimit': '-16.14', 'ciUpperLimit': '28.66', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '16.90', 'groupDescription': 'Change at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2627', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-168.4', 'ciLowerLimit': '-374.16', 'ciUpperLimit': '37.36', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '109.12', 'groupDescription': 'Change at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0047', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-36.7', 'ciLowerLimit': '-51.87', 'ciUpperLimit': '-21.60', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.38', 'groupDescription': 'Change at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1803', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-66.1', 'ciLowerLimit': '-128.37', 'ciUpperLimit': '-3.88', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '38.01', 'groupDescription': 'Change at Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7174', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '6.4', 'ciLowerLimit': '-16.62', 'ciUpperLimit': '29.35', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '17.34', 'groupDescription': 'Change at Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2551', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-163.4', 'ciLowerLimit': '-358.51', 'ciUpperLimit': '31.72', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '103.47', 'groupDescription': 'Change at Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0086', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-33.5', 'ciLowerLimit': '-48.58', 'ciUpperLimit': '-18.36', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.36', 'groupDescription': 'Change at Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2576', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-56.0', 'ciLowerLimit': '-121.78', 'ciUpperLimit': '9.78', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '40.16', 'groupDescription': 'Change at Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9722', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.6', 'ciLowerLimit': '-24.62', 'ciUpperLimit': '23.34', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '18.09', 'groupDescription': 'Change at Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2051', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-177.4', 'ciLowerLimit': '-357.85', 'ciUpperLimit': '3.13', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '95.72', 'groupDescription': 'Change at Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0025', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-42.0', 'ciLowerLimit': '-57.98', 'ciUpperLimit': '-26.08', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.99', 'groupDescription': 'Change at Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1465', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-65.8', 'ciLowerLimit': '-121.14', 'ciUpperLimit': '-10.50', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '33.78', 'groupDescription': 'Change at Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7734', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '5.1', 'ciLowerLimit': '-18.13', 'ciUpperLimit': '28.37', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '17.54', 'groupDescription': 'Change at Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1826', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-175.5', 'ciLowerLimit': '-340.37', 'ciUpperLimit': '-10.56', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '87.45', 'groupDescription': 'Change at Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0105', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-39.2', 'ciLowerLimit': '-57.40', 'ciUpperLimit': '-20.93', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.71', 'groupDescription': 'Change at Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2737', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-53.7', 'ciLowerLimit': '-119.49', 'ciUpperLimit': '12.09', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '40.17', 'groupDescription': 'Change at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8692', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '3.0', 'ciLowerLimit': '-20.59', 'ciUpperLimit': '26.52', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '17.77', 'groupDescription': 'Change at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2106', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-163.0', 'ciLowerLimit': '-332.06', 'ciUpperLimit': '5.99', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '89.64', 'groupDescription': 'Change at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0060', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-45.7', 'ciLowerLimit': '-65.19', 'ciUpperLimit': '-26.14', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '14.67', 'groupDescription': 'Change at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1831', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-62.3', 'ciLowerLimit': '-121.44', 'ciUpperLimit': '-3.13', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '36.12', 'groupDescription': 'Change at Week 10', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2061', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '21.5', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '43.30', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '16.39', 'groupDescription': 'Change at Week 10', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2073', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-161.4', 'ciLowerLimit': '-326.83', 'ciUpperLimit': '4.12', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '87.75', 'groupDescription': 'Change at Week 10', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0371', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-34.4', 'ciLowerLimit': '-54.62', 'ciUpperLimit': '-14.10', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '15.19', 'groupDescription': 'Change at Week 10', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2393', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-55.2', 'ciLowerLimit': '-117.01', 'ciUpperLimit': '6.54', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '37.72', 'groupDescription': 'Change at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9019', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '2.4', 'ciLowerLimit': '-22.91', 'ciUpperLimit': '27.67', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '19.01', 'groupDescription': 'Change at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2103', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-149.2', 'ciLowerLimit': '-303.77', 'ciUpperLimit': '5.35', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '81.97', 'groupDescription': 'Change at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1634', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-22.1', 'ciLowerLimit': '-42.40', 'ciUpperLimit': '-1.88', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '15.20', 'groupDescription': 'Change at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2727', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-48.6', 'ciLowerLimit': '-108.04', 'ciUpperLimit': '10.80', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '36.28', 'groupDescription': 'Change at Week 14', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5839', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-9.6', 'ciLowerLimit': '-32.65', 'ciUpperLimit': '13.36', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '17.29', 'groupDescription': 'Change at Week 14', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1597', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-167.8', 'ciLowerLimit': '-312.25', 'ciUpperLimit': '-23.45', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '76.58', 'groupDescription': 'Change at Week 14', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1138', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-27.1', 'ciLowerLimit': '-48.81', 'ciUpperLimit': '-5.43', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '16.27', 'groupDescription': 'Change at Week 14', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0888', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-62.0', 'ciLowerLimit': '-102.78', 'ciUpperLimit': '-21.13', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '24.93', 'groupDescription': 'Change at Week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9741', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.6', 'ciLowerLimit': '-24.79', 'ciUpperLimit': '23.60', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '18.19', 'groupDescription': 'Change at Week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1354', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-159.2', 'ciLowerLimit': '-282.59', 'ciUpperLimit': '-35.87', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '65.42', 'groupDescription': 'Change at Week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1425', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-26.5', 'ciLowerLimit': '-49.41', 'ciUpperLimit': '-3.52', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '17.21', 'groupDescription': 'Change at Week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1326', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-54.6', 'ciLowerLimit': '-98.18', 'ciUpperLimit': '-11.01', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '26.61', 'groupDescription': 'Change at Week 18', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8433', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-4.2', 'ciLowerLimit': '-31.95', 'ciUpperLimit': '23.58', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '20.87', 'groupDescription': 'Change at Week 18', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0768', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-130.8', 'ciLowerLimit': '-203.39', 'ciUpperLimit': '-58.19', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '38.50', 'groupDescription': 'Change at Week 18', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3341', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-18.6', 'ciLowerLimit': '-43.49', 'ciUpperLimit': '6.34', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '18.69', 'groupDescription': 'Change at Week 18', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 1-8, 10, 12, 14, 16, 18', 'description': 'Participants were asked to place a line perpendicular to the VAS line at the point that represents the intensity of their average pruritus experienced over the previous 3 days using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 5-D Pruritus Total Score Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'KPL-716: CIU Cohort', 'description': 'Participants with CIU received KPL-716 weekly for 8 weeks'}, {'id': 'OG001', 'title': 'Placebo: CIU Cohort', 'description': 'Participants with CIU received placebo weekly for 8 weeks'}, {'id': 'OG002', 'title': 'KPL-716: CIP Cohort', 'description': 'Participants with CIP received KPL-716 weekly for 8 weeks'}, {'id': 'OG003', 'title': 'Placebo: CIP Cohort', 'description': 'Participants with CIP received placebo weekly for 8 weeks'}, {'id': 'OG004', 'title': 'KPL-716: LP Cohort', 'description': 'Participants with LP received KPL-716 weekly for 8 weeks'}, {'id': 'OG005', 'title': 'Placebo: LP Cohort', 'description': 'Participants with LP received placebo weekly for 8 weeks'}, {'id': 'OG006', 'title': 'KPL-716: LSC Cohort', 'description': 'Participants with LSC received KPL-716 weekly for 8 weeks'}, {'id': 'OG007', 'title': 'Placebo: LSC Cohort', 'description': 'Participants with LSC received placebo weekly for 8 weeks'}, {'id': 'OG008', 'title': 'KPL-716: PPs Cohort', 'description': 'Participants with PPs received KPL-716 weekly for 8 weeks'}, {'id': 'OG009', 'title': 'Placebo: PPs Cohort', 'description': 'Participants with PPs received placebo weekly for 8 weeks'}], 'classes': [{'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-6.3', 'spread': '2.78', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '-4.4', 'spread': '1.06', 'groupId': 'OG002'}, {'value': '-4.0', 'spread': '1.35', 'groupId': 'OG003'}, {'value': '-2.3', 'spread': '1.20', 'groupId': 'OG004'}, {'value': '-6.8', 'spread': '2.10', 'groupId': 'OG006'}, {'value': '-4.0', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-5.0', 'spread': '1.19', 'groupId': 'OG008'}, {'value': '-3.6', 'spread': '1.29', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-8.5', 'spread': '2.02', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '-4.5', 'spread': '1.27', 'groupId': 'OG002'}, {'value': '-5.4', 'spread': '1.65', 'groupId': 'OG003'}, {'value': '-7.3', 'spread': '4.06', 'groupId': 'OG004'}, {'value': '-7.3', 'spread': '2.78', 'groupId': 'OG006'}, {'value': '-4.0', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-7.7', 'spread': '1.05', 'groupId': 'OG008'}, {'value': '-4.1', 'spread': '1.81', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-8.3', 'spread': '2.17', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '-6.6', 'spread': '1.23', 'groupId': 'OG002'}, {'value': '-5.8', 'spread': '1.47', 'groupId': 'OG003'}, {'value': '-8.0', 'spread': '4.16', 'groupId': 'OG004'}, {'value': '-8.5', 'spread': '2.90', 'groupId': 'OG006'}, {'value': '-7.0', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-8.2', 'spread': '1.05', 'groupId': 'OG008'}, {'value': '-5.0', 'spread': '1.79', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-7.5', 'spread': '2.22', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '-6.5', 'spread': '1.32', 'groupId': 'OG002'}, {'value': '-6.8', 'spread': '1.23', 'groupId': 'OG003'}, {'value': '-8.0', 'spread': '4.16', 'groupId': 'OG004'}, {'value': '-8.8', 'spread': '2.95', 'groupId': 'OG006'}, {'value': '-7.0', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-9.4', 'spread': '1.09', 'groupId': 'OG008'}, {'value': '-5.0', 'spread': '1.75', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-8.0', 'spread': '1.68', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '1.00', 'groupId': 'OG001'}, {'value': '-6.6', 'spread': '1.50', 'groupId': 'OG002'}, {'value': '-7.9', 'spread': '0.63', 'groupId': 'OG003'}, {'value': '-12.0', 'spread': '2.00', 'groupId': 'OG004'}, {'value': '-9.5', 'spread': '2.87', 'groupId': 'OG006'}, {'value': '-7.0', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-9.4', 'spread': '1.46', 'groupId': 'OG008'}, {'value': '-6.0', 'spread': '1.81', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-7.0', 'spread': '2.42', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '-6.3', 'spread': '1.33', 'groupId': 'OG002'}, {'value': '-6.3', 'spread': '1.04', 'groupId': 'OG003'}, {'value': '-12.0', 'spread': '2.00', 'groupId': 'OG004'}, {'value': '-9.8', 'spread': '2.63', 'groupId': 'OG006'}, {'value': '-8.0', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-9.6', 'spread': '1.32', 'groupId': 'OG008'}, {'value': '-6.3', 'spread': '1.71', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-4.0', 'spread': '3.37', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '-6.7', 'spread': '1.08', 'groupId': 'OG002'}, {'value': '-6.1', 'spread': '1.17', 'groupId': 'OG003'}, {'value': '-12.0', 'spread': '2.00', 'groupId': 'OG004'}, {'value': '-9.5', 'spread': '2.87', 'groupId': 'OG006'}, {'value': '-4.0', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-9.6', 'spread': '1.53', 'groupId': 'OG008'}, {'value': '-6.5', 'spread': '1.78', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-7.8', 'spread': '2.10', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '-7.1', 'spread': '1.77', 'groupId': 'OG002'}, {'value': '-5.0', 'spread': '1.47', 'groupId': 'OG003'}, {'value': '-11.5', 'spread': '2.50', 'groupId': 'OG004'}, {'value': '-10.0', 'spread': '2.38', 'groupId': 'OG006'}, {'value': '-2.0', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-9.6', 'spread': '1.48', 'groupId': 'OG008'}, {'value': '-7.2', 'spread': '1.97', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-6.5', 'spread': '2.50', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '-6.3', 'spread': '1.82', 'groupId': 'OG002'}, {'value': '-4.6', 'spread': '1.42', 'groupId': 'OG003'}, {'value': '-13.5', 'spread': '3.50', 'groupId': 'OG004'}, {'value': '-10.0', 'spread': '2.38', 'groupId': 'OG006'}, {'value': '-2.0', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-8.9', 'spread': '1.57', 'groupId': 'OG008'}, {'value': '-7.0', 'spread': '1.65', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18', 'description': 'This tool evaluates pruritus in 5 domains: duration, degree, direction, disability and distribution. Duration, degree and direction each consist of 1 item. The disability domain contains 4 items and the distribution domain includes 16 items. The first 4 domains are measured on a 5-point Likert scale. The scores from each domain are added together to obtain a total 5-D score ranging from 5 (no pruritus) and 25 (most severe pruritus).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in 5-D Pruritus Total Score Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'KPL-716: CIU Cohort', 'description': 'Participants with CIU received KPL-716 weekly for 8 weeks'}, {'id': 'OG001', 'title': 'Placebo: CIU Cohort', 'description': 'Participants with CIU received placebo weekly for 8 weeks'}, {'id': 'OG002', 'title': 'KPL-716: CIP Cohort', 'description': 'Participants with CIP received KPL-716 weekly for 8 weeks'}, {'id': 'OG003', 'title': 'Placebo: CIP Cohort', 'description': 'Participants with CIP received placebo weekly for 8 weeks'}, {'id': 'OG004', 'title': 'KPL-716: LP Cohort', 'description': 'Participants with LP received KPL-716 weekly for 8 weeks'}, {'id': 'OG005', 'title': 'Placebo: LP Cohort', 'description': 'Participants with LP received placebo weekly for 8 weeks'}, {'id': 'OG006', 'title': 'KPL-716: LSC Cohort', 'description': 'Participants with LSC received KPL-716 weekly for 8 weeks'}, {'id': 'OG007', 'title': 'Placebo: LSC Cohort', 'description': 'Participants with LSC received placebo weekly for 8 weeks'}, {'id': 'OG008', 'title': 'KPL-716: PPs Cohort', 'description': 'Participants with PPs received KPL-716 weekly for 8 weeks'}, {'id': 'OG009', 'title': 'Placebo: PPs Cohort', 'description': 'Participants with PPs received placebo weekly for 8 weeks'}], 'classes': [{'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-31.3', 'spread': '13.40', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '18.98', 'groupId': 'OG001'}, {'value': '-24.2', 'spread': '6.00', 'groupId': 'OG002'}, {'value': '-20.6', 'spread': '7.48', 'groupId': 'OG003'}, {'value': '-11.8', 'spread': '8.46', 'groupId': 'OG004'}, {'value': '-44.0', 'spread': '3.43', 'groupId': 'OG006'}, {'value': '8.4', 'spread': '8.04', 'groupId': 'OG007'}, {'value': '-25.4', 'spread': '5.38', 'groupId': 'OG008'}, {'value': '-18.8', 'spread': '7.61', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-42.7', 'spread': '9.40', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '13.31', 'groupId': 'OG001'}, {'value': '-24.1', 'spread': '7.03', 'groupId': 'OG002'}, {'value': '-29.2', 'spread': '8.77', 'groupId': 'OG003'}, {'value': '-35.1', 'spread': '12.38', 'groupId': 'OG004'}, {'value': '-49.1', 'spread': '2.09', 'groupId': 'OG006'}, {'value': '23.0', 'spread': '4.90', 'groupId': 'OG007'}, {'value': '-40.3', 'spread': '5.55', 'groupId': 'OG008'}, {'value': '-20.8', 'spread': '7.85', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-41.4', 'spread': '10.22', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '14.48', 'groupId': 'OG001'}, {'value': '-35.9', 'spread': '6.66', 'groupId': 'OG002'}, {'value': '-31.6', 'spread': '8.31', 'groupId': 'OG003'}, {'value': '-38.8', 'spread': '17.46', 'groupId': 'OG004'}, {'value': '-56.5', 'spread': '1.49', 'groupId': 'OG006'}, {'value': '9.1', 'spread': '3.49', 'groupId': 'OG007'}, {'value': '-43.3', 'spread': '5.67', 'groupId': 'OG008'}, {'value': '-25.9', 'spread': '8.02', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-37.7', 'spread': '10.85', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '15.36', 'groupId': 'OG001'}, {'value': '-34.4', 'spread': '6.30', 'groupId': 'OG002'}, {'value': '-37.2', 'spread': '7.85', 'groupId': 'OG003'}, {'value': '-38.8', 'spread': '17.46', 'groupId': 'OG004'}, {'value': '-58.1', 'spread': '0.83', 'groupId': 'OG006'}, {'value': '10.1', 'spread': '1.95', 'groupId': 'OG007'}, {'value': '-49.1', 'spread': '5.49', 'groupId': 'OG008'}, {'value': '-25.7', 'spread': '7.77', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-40.1', 'spread': '8.46', 'groupId': 'OG000'}, {'value': '-4.5', 'spread': '11.98', 'groupId': 'OG001'}, {'value': '-35.2', 'spread': '6.47', 'groupId': 'OG002'}, {'value': '-43.1', 'spread': '7.48', 'groupId': 'OG003'}, {'value': '-58.2', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-62.1', 'spread': '3.76', 'groupId': 'OG006'}, {'value': '6.6', 'spread': '8.82', 'groupId': 'OG007'}, {'value': '-49.1', 'spread': '6.55', 'groupId': 'OG008'}, {'value': '-29.6', 'spread': '10.06', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-33.3', 'spread': '9.21', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '13.05', 'groupId': 'OG001'}, {'value': '-33.5', 'spread': '6.64', 'groupId': 'OG002'}, {'value': '-34.4', 'spread': '7.66', 'groupId': 'OG003'}, {'value': '-58.2', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-62.8', 'spread': '3.53', 'groupId': 'OG006'}, {'value': '-3.4', 'spread': '8.28', 'groupId': 'OG007'}, {'value': '-50.2', 'spread': '5.86', 'groupId': 'OG008'}, {'value': '-31.4', 'spread': '9.00', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-17.9', 'spread': '14.08', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '19.95', 'groupId': 'OG001'}, {'value': '-36.2', 'spread': '5.83', 'groupId': 'OG002'}, {'value': '-33.3', 'spread': '6.74', 'groupId': 'OG003'}, {'value': '-58.2', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-62.1', 'spread': '3.76', 'groupId': 'OG006'}, {'value': '20.2', 'spread': '8.82', 'groupId': 'OG007'}, {'value': '-49.7', 'spread': '7.04', 'groupId': 'OG008'}, {'value': '-33.1', 'spread': '10.81', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-37.7', 'spread': '8.29', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '11.74', 'groupId': 'OG001'}, {'value': '-37.0', 'spread': '8.29', 'groupId': 'OG002'}, {'value': '-27.8', 'spread': '9.57', 'groupId': 'OG003'}, {'value': '-55.4', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-63.6', 'spread': '3.33', 'groupId': 'OG006'}, {'value': '18.5', 'spread': '7.81', 'groupId': 'OG007'}, {'value': '-49.9', 'spread': '7.08', 'groupId': 'OG008'}, {'value': '-36.8', 'spread': '10.88', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-31.3', 'spread': '10.41', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '14.75', 'groupId': 'OG001'}, {'value': '-32.9', 'spread': '8.83', 'groupId': 'OG002'}, {'value': '-25.0', 'spread': '10.19', 'groupId': 'OG003'}, {'value': '-64.7', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-63.6', 'spread': '3.33', 'groupId': 'OG006'}, {'value': '18.5', 'spread': '7.81', 'groupId': 'OG007'}, {'value': '-46.6', 'spread': '7.43', 'groupId': 'OG008'}, {'value': '-35.5', 'spread': '11.41', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '0.4995', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-40.9', 'ciLowerLimit': '-166.52', 'ciUpperLimit': '84.74', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '40.82', 'groupDescription': 'Change at Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7071', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-3.7', 'ciLowerLimit': '-16.37', 'ciUpperLimit': '9.06', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.59', 'groupDescription': 'Change at Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0305', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-52.5', 'ciLowerLimit': '-70.18', 'ciUpperLimit': '-34.77', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.39', 'groupDescription': 'Change at Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4884', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-6.6', 'ciLowerLimit': '-19.01', 'ciUpperLimit': '5.81', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.33', 'groupDescription': 'Change at Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2885', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-45.3', 'ciLowerLimit': '-104.93', 'ciUpperLimit': '14.35', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '31.63', 'groupDescription': 'Change at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6505', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '5.2', 'ciLowerLimit': '-9.73', 'ciUpperLimit': '20.06', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.24', 'groupDescription': 'Change at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0062', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-72.1', 'ciLowerLimit': '-82.91', 'ciUpperLimit': '-61.34', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.72', 'groupDescription': 'Change at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0571', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-19.6', 'ciLowerLimit': '-32.34', 'ciUpperLimit': '-6.76', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.62', 'groupDescription': 'Change at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-50.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.00', 'groupDescription': 'Change at Week 6', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6927', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-4.3', 'ciLowerLimit': '-18.38', 'ciUpperLimit': '9.84', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.65', 'groupDescription': 'Change at Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0038', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-65.6', 'ciLowerLimit': '-73.33', 'ciUpperLimit': '-57.94', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.08', 'groupDescription': 'Change at Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0940', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-17.4', 'ciLowerLimit': '-30.43', 'ciUpperLimit': '-4.30', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.82', 'groupDescription': 'Change at Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1694', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-72.4', 'ciLowerLimit': '-133.10', 'ciUpperLimit': '-11.65', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '19.73', 'groupDescription': 'Change at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7811', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '2.8', 'ciLowerLimit': '-10.50', 'ciUpperLimit': '16.18', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.07', 'groupDescription': 'Change at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0011', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-68.2', 'ciLowerLimit': '-72.51', 'ciUpperLimit': '-63.91', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.28', 'groupDescription': 'Change at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0245', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-23.4', 'ciLowerLimit': '-36.02', 'ciUpperLimit': '-10.70', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.52', 'groupDescription': 'Change at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0603', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-61.8', 'ciLowerLimit': '-79.88', 'ciUpperLimit': '-43.74', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.87', 'groupDescription': 'Change at Week 10', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4365', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '7.9', 'ciLowerLimit': '-5.29', 'ciUpperLimit': '21.04', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.89', 'groupDescription': 'Change at Week 10', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0218', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-68.7', 'ciLowerLimit': '-88.11', 'ciUpperLimit': '-49.26', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.30', 'groupDescription': 'Change at Week 10', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1238', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-19.5', 'ciLowerLimit': '-35.65', 'ciUpperLimit': '-3.45', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.07', 'groupDescription': 'Change at Week 10', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1437', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-54.8', 'ciLowerLimit': '-98.88', 'ciUpperLimit': '-10.72', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '23.38', 'groupDescription': 'Change at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9279', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.9', 'ciLowerLimit': '-12.56', 'ciUpperLimit': '14.43', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.14', 'groupDescription': 'Change at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0254', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-59.5', 'ciLowerLimit': '-77.69', 'ciUpperLimit': '-41.24', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.67', 'groupDescription': 'Change at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0994', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-18.8', 'ciLowerLimit': '-33.23', 'ciUpperLimit': '-4.43', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.80', 'groupDescription': 'Change at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3656', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-45.7', 'ciLowerLimit': '-119.90', 'ciUpperLimit': '28.54', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '39.36', 'groupDescription': 'Change at Week 14', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7465', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-2.9', 'ciLowerLimit': '-14.79', 'ciUpperLimit': '8.94', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.92', 'groupDescription': 'Change at Week 14', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0153', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-82.3', 'ciLowerLimit': '-101.75', 'ciUpperLimit': '-62.90', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.30', 'groupDescription': 'Change at Week 14', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2184', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-16.6', 'ciLowerLimit': '-33.88', 'ciUpperLimit': '0.72', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.97', 'groupDescription': 'Change at Week 14', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7726', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-8.1', 'ciLowerLimit': '-50.37', 'ciUpperLimit': '34.07', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '25.78', 'groupDescription': 'Change at Week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4760', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-9.2', 'ciLowerLimit': '-26.07', 'ciUpperLimit': '7.63', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.66', 'groupDescription': 'Change at Week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0121', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-82.1', 'ciLowerLimit': '-99.26', 'ciUpperLimit': '-64.87', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.12', 'groupDescription': 'Change at Week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3329', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-13.0', 'ciLowerLimit': '-30.43', 'ciUpperLimit': '4.40', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.06', 'groupDescription': 'Change at Week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9564', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-1.7', 'ciLowerLimit': '-48.31', 'ciUpperLimit': '44.92', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '28.46', 'groupDescription': 'Change at Week 18', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5661', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-7.9', 'ciLowerLimit': '-25.84', 'ciUpperLimit': '10.06', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.49', 'groupDescription': 'Change at Week 18', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0121', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-82.1', 'ciLowerLimit': '-99.26', 'ciUpperLimit': '-64.87', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.12', 'groupDescription': 'Change at Week 18', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4275', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-11.1', 'ciLowerLimit': '-29.40', 'ciUpperLimit': '7.13', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.70', 'groupDescription': 'Change at Week 18', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18', 'description': 'This tool evaluates pruritus in 5 domains: duration, degree, direction, disability and distribution. Duration, degree and direction each consist of 1 item. The disability domain contains 4 items and the distribution domain includes 16 items. The first 4 domains are measured on a 5-point Likert scale. The scores from each domain are added together to obtain a total 5-D score ranging from 5 (no pruritus) and 25 (most severe pruritus).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'KPL-716: CIU Cohort', 'description': 'Participants with CIU received KPL-716 weekly for 8 weeks'}, {'id': 'OG001', 'title': 'Placebo: CIU Cohort', 'description': 'Participants with CIU received placebo weekly for 8 weeks'}, {'id': 'OG002', 'title': 'KPL-716: CIP Cohort', 'description': 'Participants with CIP received KPL-716 weekly for 8 weeks'}, {'id': 'OG003', 'title': 'Placebo: CIP Cohort', 'description': 'Participants with CIP received placebo weekly for 8 weeks'}, {'id': 'OG004', 'title': 'KPL-716: LP Cohort', 'description': 'Participants with LP received KPL-716 weekly for 8 weeks'}, {'id': 'OG005', 'title': 'Placebo: LP Cohort', 'description': 'Participants with LP received placebo weekly for 8 weeks'}, {'id': 'OG006', 'title': 'KPL-716: LSC Cohort', 'description': 'Participants with LSC received KPL-716 weekly for 8 weeks'}, {'id': 'OG007', 'title': 'Placebo: LSC Cohort', 'description': 'Participants with LSC received placebo weekly for 8 weeks'}, {'id': 'OG008', 'title': 'KPL-716: PPs Cohort', 'description': 'Participants with PPs received KPL-716 weekly for 8 weeks'}, {'id': 'OG009', 'title': 'Placebo: PPs Cohort', 'description': 'Participants with PPs received placebo weekly for 8 weeks'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '60.2'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '84.2'}, {'value': '21.4', 'groupId': 'OG002', 'lowerLimit': '4.7', 'upperLimit': '50.8'}, {'value': '11.1', 'groupId': 'OG003', 'lowerLimit': '0.3', 'upperLimit': '48.2'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '70.8'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '6.8', 'upperLimit': '93.2'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '97.5'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '23.2'}, {'value': '0.0', 'groupId': 'OG009', 'lowerLimit': '0.0', 'upperLimit': '41.0'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '93.2'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '84.2'}, {'value': '28.6', 'groupId': 'OG002', 'lowerLimit': '8.4', 'upperLimit': '58.1'}, {'value': '33.3', 'groupId': 'OG003', 'lowerLimit': '7.5', 'upperLimit': '70.1'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '70.8'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '6.8', 'upperLimit': '93.2'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '97.5'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '23.2'}, {'value': '0.0', 'groupId': 'OG009', 'lowerLimit': '0.0', 'upperLimit': '41.0'}]}]}, {'title': 'Change at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '93.2'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '84.2'}, {'value': '42.9', 'groupId': 'OG002', 'lowerLimit': '17.7', 'upperLimit': '71.1'}, {'value': '33.3', 'groupId': 'OG003', 'lowerLimit': '7.5', 'upperLimit': '70.1'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '70.8'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '6.8', 'upperLimit': '93.2'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '97.5'}, {'value': '21.4', 'groupId': 'OG008', 'lowerLimit': '4.7', 'upperLimit': '50.8'}, {'value': '0.0', 'groupId': 'OG009', 'lowerLimit': '0.0', 'upperLimit': '41.0'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '93.2'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '84.2'}, {'value': '42.9', 'groupId': 'OG002', 'lowerLimit': '17.7', 'upperLimit': '71.1'}, {'value': '44.4', 'groupId': 'OG003', 'lowerLimit': '13.7', 'upperLimit': '78.8'}, {'value': '33.3', 'groupId': 'OG004', 'lowerLimit': '0.8', 'upperLimit': '90.6'}, {'value': '75.0', 'groupId': 'OG006', 'lowerLimit': '19.4', 'upperLimit': '99.4'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '97.5'}, {'value': '42.9', 'groupId': 'OG008', 'lowerLimit': '17.7', 'upperLimit': '71.1'}, {'value': '14.3', 'groupId': 'OG009', 'lowerLimit': '0.4', 'upperLimit': '57.9'}]}]}, {'title': 'Change at Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '93.2'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '84.2'}, {'value': '50.0', 'groupId': 'OG002', 'lowerLimit': '23.0', 'upperLimit': '77.0'}, {'value': '44.4', 'groupId': 'OG003', 'lowerLimit': '13.7', 'upperLimit': '78.8'}, {'value': '33.3', 'groupId': 'OG004', 'lowerLimit': '0.8', 'upperLimit': '90.6'}, {'value': '75.0', 'groupId': 'OG006', 'lowerLimit': '19.4', 'upperLimit': '99.4'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '97.5'}, {'value': '50.0', 'groupId': 'OG008', 'lowerLimit': '23.0', 'upperLimit': '77.0'}, {'value': '14.3', 'groupId': 'OG009', 'lowerLimit': '0.4', 'upperLimit': '57.9'}]}]}, {'title': 'Change at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '93.2'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '84.2'}, {'value': '57.1', 'groupId': 'OG002', 'lowerLimit': '28.9', 'upperLimit': '82.3'}, {'value': '66.7', 'groupId': 'OG003', 'lowerLimit': '29.9', 'upperLimit': '92.5'}, {'value': '33.3', 'groupId': 'OG004', 'lowerLimit': '0.8', 'upperLimit': '90.6'}, {'value': '75.0', 'groupId': 'OG006', 'lowerLimit': '19.4', 'upperLimit': '99.4'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '97.5'}, {'value': '57.1', 'groupId': 'OG008', 'lowerLimit': '28.9', 'upperLimit': '82.3'}, {'value': '14.3', 'groupId': 'OG009', 'lowerLimit': '0.4', 'upperLimit': '57.9'}]}]}, {'title': 'Change at Week 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '93.2'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '57.1', 'groupId': 'OG002', 'lowerLimit': '28.9', 'upperLimit': '82.3'}, {'value': '55.6', 'groupId': 'OG003', 'lowerLimit': '21.2', 'upperLimit': '86.3'}, {'value': '66.7', 'groupId': 'OG004', 'lowerLimit': '9.4', 'upperLimit': '99.2'}, {'value': '75.0', 'groupId': 'OG006', 'lowerLimit': '19.4', 'upperLimit': '99.4'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '97.5'}, {'value': '64.3', 'groupId': 'OG008', 'lowerLimit': '35.1', 'upperLimit': '87.2'}, {'value': '14.3', 'groupId': 'OG009', 'lowerLimit': '0.4', 'upperLimit': '57.9'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '93.2'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '84.2'}, {'value': '57.1', 'groupId': 'OG002', 'lowerLimit': '28.9', 'upperLimit': '82.3'}, {'value': '66.7', 'groupId': 'OG003', 'lowerLimit': '29.9', 'upperLimit': '92.5'}, {'value': '66.7', 'groupId': 'OG004', 'lowerLimit': '9.4', 'upperLimit': '99.2'}, {'value': '75.0', 'groupId': 'OG006', 'lowerLimit': '19.4', 'upperLimit': '99.4'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '97.5'}, {'value': '71.4', 'groupId': 'OG008', 'lowerLimit': '41.9', 'upperLimit': '91.6'}, {'value': '28.6', 'groupId': 'OG009', 'lowerLimit': '3.7', 'upperLimit': '71.0'}]}]}, {'title': 'Change at Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '93.2'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '84.2'}, {'value': '58.3', 'groupId': 'OG002', 'lowerLimit': '27.7', 'upperLimit': '84.8'}, {'value': '55.6', 'groupId': 'OG003', 'lowerLimit': '21.2', 'upperLimit': '86.3'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '15.8', 'upperLimit': '100.0'}, {'value': '75.0', 'groupId': 'OG006', 'lowerLimit': '19.4', 'upperLimit': '99.4'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '97.5'}, {'value': '78.6', 'groupId': 'OG008', 'lowerLimit': '49.2', 'upperLimit': '95.3'}, {'value': '28.6', 'groupId': 'OG009', 'lowerLimit': '3.7', 'upperLimit': '71.0'}]}]}, {'title': 'Change at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '80.6'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '50.0', 'groupId': 'OG002', 'lowerLimit': '21.1', 'upperLimit': '78.9'}, {'value': '77.8', 'groupId': 'OG003', 'lowerLimit': '40.0', 'upperLimit': '97.2'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '15.8', 'upperLimit': '100.0'}, {'value': '75.0', 'groupId': 'OG006', 'lowerLimit': '19.4', 'upperLimit': '99.4'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '97.5'}, {'value': '78.6', 'groupId': 'OG008', 'lowerLimit': '49.2', 'upperLimit': '95.3'}, {'value': '14.3', 'groupId': 'OG009', 'lowerLimit': '0.4', 'upperLimit': '57.9'}]}]}, {'title': 'Change at Week 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '93.2'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '58.3', 'groupId': 'OG002', 'lowerLimit': '27.7', 'upperLimit': '84.8'}, {'value': '77.8', 'groupId': 'OG003', 'lowerLimit': '40.0', 'upperLimit': '97.2'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '15.8', 'upperLimit': '100.0'}, {'value': '75.0', 'groupId': 'OG006', 'lowerLimit': '19.4', 'upperLimit': '99.4'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '97.5'}, {'value': '64.3', 'groupId': 'OG008', 'lowerLimit': '35.1', 'upperLimit': '87.2'}, {'value': '14.3', 'groupId': 'OG009', 'lowerLimit': '0.4', 'upperLimit': '57.9'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '93.2'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '58.3', 'groupId': 'OG002', 'lowerLimit': '27.7', 'upperLimit': '84.8'}, {'value': '66.7', 'groupId': 'OG003', 'lowerLimit': '29.9', 'upperLimit': '92.5'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '15.8', 'upperLimit': '100.0'}, {'value': '75.0', 'groupId': 'OG006', 'lowerLimit': '19.4', 'upperLimit': '99.4'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '97.5'}, {'value': '64.3', 'groupId': 'OG008', 'lowerLimit': '35.1', 'upperLimit': '87.2'}, {'value': '14.3', 'groupId': 'OG009', 'lowerLimit': '0.4', 'upperLimit': '57.9'}]}]}, {'title': 'Change at Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '80.6'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '58.3', 'groupId': 'OG002', 'lowerLimit': '27.7', 'upperLimit': '84.8'}, {'value': '55.6', 'groupId': 'OG003', 'lowerLimit': '21.2', 'upperLimit': '86.3'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '15.8', 'upperLimit': '100.0'}, {'value': '75.0', 'groupId': 'OG006', 'lowerLimit': '19.4', 'upperLimit': '99.4'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '97.5'}, {'value': '71.4', 'groupId': 'OG008', 'lowerLimit': '41.9', 'upperLimit': '91.6'}, {'value': '14.3', 'groupId': 'OG009', 'lowerLimit': '0.4', 'upperLimit': '57.9'}]}]}, {'title': 'Change at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '80.6'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '58.3', 'groupId': 'OG002', 'lowerLimit': '27.7', 'upperLimit': '84.8'}, {'value': '55.6', 'groupId': 'OG003', 'lowerLimit': '21.2', 'upperLimit': '86.3'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '15.8', 'upperLimit': '100.0'}, {'value': '75.0', 'groupId': 'OG006', 'lowerLimit': '19.4', 'upperLimit': '99.4'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '97.5'}, {'value': '71.4', 'groupId': 'OG008', 'lowerLimit': '41.9', 'upperLimit': '91.6'}, {'value': '14.3', 'groupId': 'OG009', 'lowerLimit': '0.4', 'upperLimit': '57.9'}]}]}, {'title': 'Change at Week 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '93.2'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '50.0', 'groupId': 'OG002', 'lowerLimit': '21.1', 'upperLimit': '78.9'}, {'value': '44.4', 'groupId': 'OG003', 'lowerLimit': '13.7', 'upperLimit': '78.8'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '15.8', 'upperLimit': '100.0'}, {'value': '75.0', 'groupId': 'OG006', 'lowerLimit': '19.4', 'upperLimit': '99.4'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '97.5'}, {'value': '71.4', 'groupId': 'OG008', 'lowerLimit': '41.9', 'upperLimit': '91.6'}, {'value': '28.6', 'groupId': 'OG009', 'lowerLimit': '3.7', 'upperLimit': '71.0'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '80.6'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '58.3', 'groupId': 'OG002', 'lowerLimit': '27.7', 'upperLimit': '84.8'}, {'value': '44.4', 'groupId': 'OG003', 'lowerLimit': '13.7', 'upperLimit': '78.8'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '15.8', 'upperLimit': '100.0'}, {'value': '75.0', 'groupId': 'OG006', 'lowerLimit': '19.4', 'upperLimit': '99.4'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '97.5'}, {'value': '71.4', 'groupId': 'OG008', 'lowerLimit': '41.9', 'upperLimit': '91.6'}, {'value': '28.6', 'groupId': 'OG009', 'lowerLimit': '3.7', 'upperLimit': '71.0'}]}]}, {'title': 'Change at Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '19.4', 'upperLimit': '99.4'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '50.0', 'groupId': 'OG002', 'lowerLimit': '21.1', 'upperLimit': '78.9'}, {'value': '44.4', 'groupId': 'OG003', 'lowerLimit': '13.7', 'upperLimit': '78.8'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '15.8', 'upperLimit': '100.0'}, {'value': '75.0', 'groupId': 'OG006', 'lowerLimit': '19.4', 'upperLimit': '99.4'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '97.5'}, {'value': '71.4', 'groupId': 'OG008', 'lowerLimit': '41.9', 'upperLimit': '91.6'}, {'value': '28.6', 'groupId': 'OG009', 'lowerLimit': '3.7', 'upperLimit': '71.0'}]}]}, {'title': 'Change at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '19.4', 'upperLimit': '99.4'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '58.3', 'groupId': 'OG002', 'lowerLimit': '27.7', 'upperLimit': '84.8'}, {'value': '44.4', 'groupId': 'OG003', 'lowerLimit': '13.7', 'upperLimit': '78.8'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '15.8', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG006', 'lowerLimit': '39.8', 'upperLimit': '100.0'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '97.5'}, {'value': '71.4', 'groupId': 'OG008', 'lowerLimit': '41.9', 'upperLimit': '91.6'}, {'value': '28.6', 'groupId': 'OG009', 'lowerLimit': '3.7', 'upperLimit': '71.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 1-18', 'description': 'WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'KPL-716: CIU Cohort', 'description': 'Participants with CIU received KPL-716 weekly for 8 weeks'}, {'id': 'OG001', 'title': 'Placebo: CIU Cohort', 'description': 'Participants with CIU received placebo weekly for 8 weeks'}], 'classes': [{'title': 'Change at Week 1', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.29', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.21', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 3', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.36', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.21', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 5', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.21', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 7', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.43', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 9', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 10', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.50', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 11', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.57', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.57', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 13', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.57', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 14', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.57', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 15', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.57', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 16', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.57', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 17', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.57', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 18', 'categories': [{'measurements': [{'value': '-1.3', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 1-18', 'description': 'Participants were asked daily to self-assess the intensity of their pruritus on a Weekly Average Itch Severity Score, which is a Component of Urticaria Activity Score 7 (UAS7). The score for pruritis was graded from 0 (none) to 3 (intense), which was averaged over 7 consecutive days. The greater the severity of the disease the higher the score. Per protocol, the UAS7 tool was completed only by participants in the CIU Cohort.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'KPL-716: CIU Cohort', 'description': 'Participants with CIU received KPL-716 weekly for 8 weeks'}, {'id': 'OG001', 'title': 'Placebo: CIU Cohort', 'description': 'Participants with CIU received placebo weekly for 8 weeks'}], 'classes': [{'title': 'Change at Week 1', 'categories': [{'measurements': [{'value': '-26.6', 'spread': '5.36', 'groupId': 'OG000'}, {'value': '-13.3', 'spread': '13.33', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2', 'categories': [{'measurements': [{'value': '-36.4', 'spread': '4.94', 'groupId': 'OG000'}, {'value': '-10.0', 'spread': '10.00', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 3', 'categories': [{'measurements': [{'value': '-40.8', 'spread': '11.29', 'groupId': 'OG000'}, {'value': '-16.7', 'spread': '16.67', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '-45.5', 'spread': '8.82', 'groupId': 'OG000'}, {'value': '-10.0', 'spread': '10.00', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 5', 'categories': [{'measurements': [{'value': '-48.7', 'spread': '8.76', 'groupId': 'OG000'}, {'value': '-10.0', 'spread': '10.00', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6', 'categories': [{'measurements': [{'value': '-54.6', 'spread': '5.27', 'groupId': 'OG000'}, {'value': '-6.7', 'spread': '6.67', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 7', 'categories': [{'measurements': [{'value': '-43.8', 'spread': '8.48', 'groupId': 'OG000'}, {'value': '-20.0', 'spread': '20.00', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '-31.5', 'spread': '12.83', 'groupId': 'OG000'}, {'value': '-6.7', 'spread': '6.67', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 9', 'categories': [{'measurements': [{'value': '-48.3', 'spread': '6.99', 'groupId': 'OG000'}, {'value': '-6.7', 'spread': '6.67', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 10', 'categories': [{'measurements': [{'value': '-41.5', 'spread': '11.05', 'groupId': 'OG000'}, {'value': '-23.3', 'spread': '23.33', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 11', 'categories': [{'measurements': [{'value': '-36.9', 'spread': '12.65', 'groupId': 'OG000'}, {'value': '-26.7', 'spread': '26.67', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '-38.4', 'spread': '13.06', 'groupId': 'OG000'}, {'value': '-26.7', 'spread': '26.67', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 13', 'categories': [{'measurements': [{'value': '-26.4', 'spread': '14.24', 'groupId': 'OG000'}, {'value': '-26.7', 'spread': '26.67', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 14', 'categories': [{'measurements': [{'value': '-33.7', 'spread': '13.07', 'groupId': 'OG000'}, {'value': '-26.7', 'spread': '26.67', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 15', 'categories': [{'measurements': [{'value': '-41.4', 'spread': '12.71', 'groupId': 'OG000'}, {'value': '-26.7', 'spread': '26.67', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 16', 'categories': [{'measurements': [{'value': '-33.8', 'spread': '12.37', 'groupId': 'OG000'}, {'value': '-26.7', 'spread': '26.67', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 17', 'categories': [{'measurements': [{'value': '-44.0', 'spread': '11.58', 'groupId': 'OG000'}, {'value': '-26.7', 'spread': '26.67', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 18', 'categories': [{'measurements': [{'value': '-51.5', 'spread': '5.65', 'groupId': 'OG000'}, {'value': '-26.7', 'spread': '26.67', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 1-18', 'description': 'Participants were asked daily to self-assess the intensity of their pruritus on a Weekly Average Itch Severity Score, which is a Component of Urticaria Activity Score 7 (UAS7). The score for pruritis was graded from 0 (none) to 3 (intense), which was averaged over 7 consecutive days. The greater the severity of the disease the higher the score. Per protocol, the UAS7 tool was completed only by participants in the CIU Cohort', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sleep Loss VAS Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'KPL-716: CIU Cohort', 'description': 'Participants with CIU received KPL-716 weekly for 8 weeks'}, {'id': 'OG001', 'title': 'Placebo: CIU Cohort', 'description': 'Participants with CIU received placebo weekly for 8 weeks'}, {'id': 'OG002', 'title': 'KPL-716: CIP Cohort', 'description': 'Participants with CIP received KPL-716 weekly for 8 weeks'}, {'id': 'OG003', 'title': 'Placebo: CIP Cohort', 'description': 'Participants with CIP received placebo weekly for 8 weeks'}, {'id': 'OG004', 'title': 'KPL-716: LP Cohort', 'description': 'Participants with LP received KPL-716 weekly for 8 weeks'}, {'id': 'OG005', 'title': 'Placebo: LP Cohort', 'description': 'Participants with LP received placebo weekly for 8 weeks'}, {'id': 'OG006', 'title': 'KPL-716: LSC Cohort', 'description': 'Participants with LSC received KPL-716 weekly for 8 weeks'}, {'id': 'OG007', 'title': 'Placebo: LSC Cohort', 'description': 'Participants with LSC received placebo weekly for 8 weeks'}, {'id': 'OG008', 'title': 'KPL-716: PPs Cohort', 'description': 'Participants with PPs received KPL-716 weekly for 8 weeks'}, {'id': 'OG009', 'title': 'Placebo: PPs Cohort', 'description': 'Participants with PPs received placebo weekly for 8 weeks'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-1.6', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.10', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '0.78', 'groupId': 'OG002'}, {'value': '-2.1', 'spread': '1.17', 'groupId': 'OG003'}, {'value': '-0.4', 'spread': '0.31', 'groupId': 'OG004'}, {'value': '-2.8', 'spread': '1.81', 'groupId': 'OG006'}, {'value': '0.1', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-1.2', 'spread': '0.25', 'groupId': 'OG008'}, {'value': '-0.1', 'spread': '0.35', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'spread': '1.46', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.10', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '0.60', 'groupId': 'OG002'}, {'value': '-2.6', 'spread': '0.71', 'groupId': 'OG003'}, {'value': '-0.3', 'spread': '0.15', 'groupId': 'OG004'}, {'value': '-3.4', 'spread': '1.98', 'groupId': 'OG006'}, {'value': '0.0', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-2.1', 'spread': '0.48', 'groupId': 'OG008'}, {'value': '-0.4', 'spread': '0.58', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '1.86', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.10', 'groupId': 'OG001'}, {'value': '-1.6', 'spread': '0.70', 'groupId': 'OG002'}, {'value': '-3.6', 'spread': '0.95', 'groupId': 'OG003'}, {'value': '-2.1', 'spread': '1.49', 'groupId': 'OG004'}, {'value': '-4.1', 'spread': '1.97', 'groupId': 'OG006'}, {'value': '-0.1', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-3.0', 'spread': '0.62', 'groupId': 'OG008'}, {'value': '-1.0', 'spread': '0.75', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '2.30', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.10', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '0.80', 'groupId': 'OG002'}, {'value': '-3.4', 'spread': '0.86', 'groupId': 'OG003'}, {'value': '-2.9', 'spread': '1.87', 'groupId': 'OG004'}, {'value': '-4.2', 'spread': '1.81', 'groupId': 'OG006'}, {'value': '-0.1', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-3.7', 'spread': '0.62', 'groupId': 'OG008'}, {'value': '-0.3', 'spread': '1.30', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-3.5', 'spread': '2.34', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.10', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': '0.72', 'groupId': 'OG002'}, {'value': '-3.9', 'spread': '0.96', 'groupId': 'OG003'}, {'value': '-3.1', 'spread': '1.85', 'groupId': 'OG004'}, {'value': '-4.4', 'spread': '1.75', 'groupId': 'OG006'}, {'value': '-2.6', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-4.0', 'spread': '0.59', 'groupId': 'OG008'}, {'value': '-1.2', 'spread': '1.14', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '2.69', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.10', 'groupId': 'OG001'}, {'value': '-2.3', 'spread': '0.74', 'groupId': 'OG002'}, {'value': '-3.6', 'spread': '0.83', 'groupId': 'OG003'}, {'value': '-3.1', 'spread': '1.85', 'groupId': 'OG004'}, {'value': '-5.0', 'spread': '1.46', 'groupId': 'OG006'}, {'value': '-1.3', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-4.6', 'spread': '0.56', 'groupId': 'OG008'}, {'value': '-1.6', 'spread': '1.20', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-3.7', 'spread': '2.16', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '-2.1', 'spread': '0.67', 'groupId': 'OG002'}, {'value': '-3.9', 'spread': '0.79', 'groupId': 'OG003'}, {'value': '-3.4', 'spread': '1.86', 'groupId': 'OG004'}, {'value': '-5.2', 'spread': '1.33', 'groupId': 'OG006'}, {'value': '-1.0', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-4.9', 'spread': '0.58', 'groupId': 'OG008'}, {'value': '-1.8', 'spread': '1.34', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '2.48', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '-2.1', 'spread': '0.67', 'groupId': 'OG002'}, {'value': '-3.8', 'spread': '0.91', 'groupId': 'OG003'}, {'value': '-3.4', 'spread': '1.86', 'groupId': 'OG004'}, {'value': '-5.3', 'spread': '1.27', 'groupId': 'OG006'}, {'value': '-1.0', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-5.4', 'spread': '0.59', 'groupId': 'OG008'}, {'value': '-2.1', 'spread': '1.29', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-3.8', 'spread': '2.20', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.10', 'groupId': 'OG001'}, {'value': '-1.7', 'spread': '0.66', 'groupId': 'OG002'}, {'value': '-5.4', 'spread': '0.80', 'groupId': 'OG003'}, {'value': '-5.5', 'spread': '0.90', 'groupId': 'OG004'}, {'value': '-5.3', 'spread': '1.29', 'groupId': 'OG006'}, {'value': '-2.4', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-5.4', 'spread': '0.63', 'groupId': 'OG008'}, {'value': '-3.1', 'spread': '1.36', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '2.14', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '-1.6', 'spread': '0.73', 'groupId': 'OG002'}, {'value': '-4.3', 'spread': '0.88', 'groupId': 'OG003'}, {'value': '-5.3', 'spread': '1.15', 'groupId': 'OG004'}, {'value': '-5.2', 'spread': '1.32', 'groupId': 'OG006'}, {'value': '-2.3', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-5.2', 'spread': '0.68', 'groupId': 'OG008'}, {'value': '-3.2', 'spread': '1.41', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '2.36', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.10', 'groupId': 'OG001'}, {'value': '-1.7', 'spread': '0.67', 'groupId': 'OG002'}, {'value': '-4.9', 'spread': '0.72', 'groupId': 'OG003'}, {'value': '-5.3', 'spread': '1.15', 'groupId': 'OG004'}, {'value': '-5.2', 'spread': '1.33', 'groupId': 'OG006'}, {'value': '-0.1', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-5.3', 'spread': '0.70', 'groupId': 'OG008'}, {'value': '-3.0', 'spread': '1.49', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-3.5', 'spread': '2.14', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.10', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '0.78', 'groupId': 'OG002'}, {'value': '-4.0', 'spread': '1.02', 'groupId': 'OG003'}, {'value': '-5.6', 'spread': '0.85', 'groupId': 'OG004'}, {'value': '-5.4', 'spread': '1.23', 'groupId': 'OG006'}, {'value': '-0.4', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-5.1', 'spread': '0.75', 'groupId': 'OG008'}, {'value': '-2.8', 'spread': '1.51', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '2.28', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '0.84', 'groupId': 'OG002'}, {'value': '-3.1', 'spread': '1.03', 'groupId': 'OG003'}, {'value': '-5.7', 'spread': '2.25', 'groupId': 'OG004'}, {'value': '-5.6', 'spread': '1.11', 'groupId': 'OG006'}, {'value': '-0.6', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-4.9', 'spread': '0.90', 'groupId': 'OG008'}, {'value': '-3.3', 'spread': '1.42', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 1-8, 10, 12, 14, 16, 18', 'description': 'Participants were asked to place a line perpendicular to the VAS line at the point that represents the intensity of their average sleeplessness experienced over the previous 3 nights using a scale from 0 to 10, with 0 indicating no sleeplessness and 10 indicating the worst imaginable sleeplessness at every visit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Sleep Loss VAS Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'KPL-716: CIU Cohort', 'description': 'Participants with CIU received KPL-716 weekly for 8 weeks'}, {'id': 'OG001', 'title': 'Placebo: CIU Cohort', 'description': 'Participants with CIU received placebo weekly for 8 weeks'}, {'id': 'OG002', 'title': 'KPL-716: CIP Cohort', 'description': 'Participants with CIP received KPL-716 weekly for 8 weeks'}, {'id': 'OG003', 'title': 'Placebo: CIP Cohort', 'description': 'Participants with CIP received placebo weekly for 8 weeks'}, {'id': 'OG004', 'title': 'KPL-716: LP Cohort', 'description': 'Participants with LP received KPL-716 weekly for 8 weeks'}, {'id': 'OG005', 'title': 'Placebo: LP Cohort', 'description': 'Participants with LP received placebo weekly for 8 weeks'}, {'id': 'OG006', 'title': 'KPL-716: LSC Cohort', 'description': 'Participants with LSC received KPL-716 weekly for 8 weeks'}, {'id': 'OG007', 'title': 'Placebo: LSC Cohort', 'description': 'Participants with LSC received placebo weekly for 8 weeks'}, {'id': 'OG008', 'title': 'KPL-716: PPs Cohort', 'description': 'Participants with PPs received KPL-716 weekly for 8 weeks'}, {'id': 'OG009', 'title': 'Placebo: PPs Cohort', 'description': 'Participants with PPs received placebo weekly for 8 weeks'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-25.1', 'spread': '20.89', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '31.37', 'groupId': 'OG001'}, {'value': '484.2', 'spread': '401.19', 'groupId': 'OG002'}, {'value': '108.2', 'spread': '483.26', 'groupId': 'OG003'}, {'value': '-5.1', 'spread': '1.04', 'groupId': 'OG004'}, {'value': '-45.5', 'spread': '27.70', 'groupId': 'OG006'}, {'value': '22.2', 'spread': '62.96', 'groupId': 'OG007'}, {'value': '-12.7', 'spread': '5.20', 'groupId': 'OG008'}, {'value': '-0.3', 'spread': '7.56', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-49.5', 'spread': '20.04', 'groupId': 'OG000'}, {'value': '9.9', 'spread': '30.10', 'groupId': 'OG001'}, {'value': '12.4', 'spread': '30.69', 'groupId': 'OG002'}, {'value': '-27.1', 'spread': '36.97', 'groupId': 'OG003'}, {'value': '-4.1', 'spread': '2.48', 'groupId': 'OG004'}, {'value': '-55.1', 'spread': '29.83', 'groupId': 'OG006'}, {'value': '22.1', 'spread': '67.80', 'groupId': 'OG007'}, {'value': '-23.9', 'spread': '8.20', 'groupId': 'OG008'}, {'value': '-5.1', 'spread': '11.91', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-38.1', 'spread': '25.21', 'groupId': 'OG000'}, {'value': '17.1', 'spread': '37.85', 'groupId': 'OG001'}, {'value': '9.9', 'spread': '44.29', 'groupId': 'OG002'}, {'value': '-47.7', 'spread': '53.35', 'groupId': 'OG003'}, {'value': '-27.6', 'spread': '7.82', 'groupId': 'OG004'}, {'value': '-66.1', 'spread': '33.17', 'groupId': 'OG006'}, {'value': '0.8', 'spread': '75.41', 'groupId': 'OG007'}, {'value': '-34.7', 'spread': '7.29', 'groupId': 'OG008'}, {'value': '-16.9', 'spread': '10.59', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-46.8', 'spread': '28.92', 'groupId': 'OG000'}, {'value': '22.4', 'spread': '43.43', 'groupId': 'OG001'}, {'value': '244.8', 'spread': '239.53', 'groupId': 'OG002'}, {'value': '15.4', 'spread': '288.53', 'groupId': 'OG003'}, {'value': '-38.5', 'spread': '13.99', 'groupId': 'OG004'}, {'value': '-67.0', 'spread': '28.94', 'groupId': 'OG006'}, {'value': '4.2', 'spread': '65.78', 'groupId': 'OG007'}, {'value': '-37.9', 'spread': '11.30', 'groupId': 'OG008'}, {'value': '2.4', 'spread': '16.42', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-56.5', 'spread': '27.85', 'groupId': 'OG000'}, {'value': '22.2', 'spread': '41.82', 'groupId': 'OG001'}, {'value': '8.2', 'spread': '50.36', 'groupId': 'OG002'}, {'value': '-52.6', 'spread': '60.66', 'groupId': 'OG003'}, {'value': '-41.1', 'spread': '17.26', 'groupId': 'OG004'}, {'value': '-70.4', 'spread': '28.63', 'groupId': 'OG006'}, {'value': '-28.9', 'spread': '65.09', 'groupId': 'OG007'}, {'value': '-47.2', 'spread': '9.43', 'groupId': 'OG008'}, {'value': '-15.7', 'spread': '13.70', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-47.6', 'spread': '34.25', 'groupId': 'OG000'}, {'value': '27.1', 'spread': '51.43', 'groupId': 'OG001'}, {'value': '-39.8', 'spread': '14.56', 'groupId': 'OG002'}, {'value': '-61.6', 'spread': '17.54', 'groupId': 'OG003'}, {'value': '-41.6', 'spread': '17.91', 'groupId': 'OG004'}, {'value': '-79.2', 'spread': '21.45', 'groupId': 'OG006'}, {'value': '-15.2', 'spread': '48.76', 'groupId': 'OG007'}, {'value': '-59.4', 'spread': '8.54', 'groupId': 'OG008'}, {'value': '-21.7', 'spread': '12.42', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-60.0', 'spread': '22.57', 'groupId': 'OG000'}, {'value': '19.5', 'spread': '33.89', 'groupId': 'OG001'}, {'value': '-17.8', 'spread': '29.08', 'groupId': 'OG002'}, {'value': '-61.5', 'spread': '35.03', 'groupId': 'OG003'}, {'value': '-45.3', 'spread': '22.49', 'groupId': 'OG004'}, {'value': '-83.1', 'spread': '18.68', 'groupId': 'OG006'}, {'value': '-14.4', 'spread': '42.45', 'groupId': 'OG007'}, {'value': '-62.3', 'spread': '10.19', 'groupId': 'OG008'}, {'value': '-24.3', 'spread': '14.80', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-54.0', 'spread': '29.23', 'groupId': 'OG000'}, {'value': '24.2', 'spread': '43.90', 'groupId': 'OG001'}, {'value': '-26.8', 'spread': '24.06', 'groupId': 'OG002'}, {'value': '-58.4', 'spread': '28.98', 'groupId': 'OG003'}, {'value': '-45.3', 'spread': '22.49', 'groupId': 'OG004'}, {'value': '-83.9', 'spread': '17.07', 'groupId': 'OG006'}, {'value': '-14.3', 'spread': '38.81', 'groupId': 'OG007'}, {'value': '-69.3', 'spread': '9.15', 'groupId': 'OG008'}, {'value': '-29.0', 'spread': '13.29', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-60.3', 'spread': '23.36', 'groupId': 'OG000'}, {'value': '20.9', 'spread': '35.07', 'groupId': 'OG001'}, {'value': '-43.8', 'spread': '8.58', 'groupId': 'OG002'}, {'value': '-86.7', 'spread': '9.51', 'groupId': 'OG003'}, {'value': '-75.0', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-84.2', 'spread': '17.92', 'groupId': 'OG006'}, {'value': '-31.1', 'spread': '40.73', 'groupId': 'OG007'}, {'value': '-68.2', 'spread': '8.29', 'groupId': 'OG008'}, {'value': '-39.9', 'spread': '12.85', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-53.6', 'spread': '13.58', 'groupId': 'OG000'}, {'value': '23.7', 'spread': '20.39', 'groupId': 'OG001'}, {'value': '45.6', 'spread': '82.52', 'groupId': 'OG002'}, {'value': '-43.2', 'spread': '91.47', 'groupId': 'OG003'}, {'value': '-71.1', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-83.4', 'spread': '18.87', 'groupId': 'OG006'}, {'value': '-30.2', 'spread': '42.89', 'groupId': 'OG007'}, {'value': '-66.1', 'spread': '8.84', 'groupId': 'OG008'}, {'value': '-41.9', 'spread': '13.71', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-49.5', 'spread': '19.46', 'groupId': 'OG000'}, {'value': '27.2', 'spread': '29.21', 'groupId': 'OG001'}, {'value': '-30.1', 'spread': '14.43', 'groupId': 'OG002'}, {'value': '-75.6', 'spread': '15.99', 'groupId': 'OG003'}, {'value': '-71.1', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-83.0', 'spread': '19.35', 'groupId': 'OG006'}, {'value': '-6.5', 'spread': '43.97', 'groupId': 'OG007'}, {'value': '-68.6', 'spread': '9.28', 'groupId': 'OG008'}, {'value': '-38.0', 'spread': '14.39', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-57.0', 'spread': '17.00', 'groupId': 'OG000'}, {'value': '22.9', 'spread': '25.53', 'groupId': 'OG001'}, {'value': '-34.4', 'spread': '15.61', 'groupId': 'OG002'}, {'value': '-69.0', 'spread': '17.30', 'groupId': 'OG003'}, {'value': '-75.7', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-85.9', 'spread': '16.02', 'groupId': 'OG006'}, {'value': '-8.9', 'spread': '36.40', 'groupId': 'OG007'}, {'value': '-66.0', 'spread': '9.77', 'groupId': 'OG008'}, {'value': '-36.7', 'spread': '15.16', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-47.3', 'spread': '11.94', 'groupId': 'OG000'}, {'value': '27.7', 'spread': '17.93', 'groupId': 'OG001'}, {'value': '-23.3', 'spread': '15.15', 'groupId': 'OG002'}, {'value': '-56.1', 'spread': '16.79', 'groupId': 'OG003'}, {'value': '-74.7', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-89.9', 'spread': '11.26', 'groupId': 'OG006'}, {'value': '-9.8', 'spread': '25.59', 'groupId': 'OG007'}, {'value': '-61.6', 'spread': '11.11', 'groupId': 'OG008'}, {'value': '-43.6', 'spread': '17.22', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '0.5403', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-27.9', 'ciLowerLimit': '-94.32', 'ciUpperLimit': '38.46', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '40.54', 'groupDescription': 'Change at Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5587', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '376.1', 'ciLowerLimit': '-462.83', 'ciUpperLimit': '1214.97', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '631.83', 'groupDescription': 'Change at Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4516', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-67.7', 'ciLowerLimit': '-205.33', 'ciUpperLimit': '69.93', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '72.99', 'groupDescription': 'Change at Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2052', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-12.5', 'ciLowerLimit': '-25.13', 'ciUpperLimit': '0.15', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.50', 'groupDescription': 'Change at Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2240', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-59.4', 'ciLowerLimit': '-123.09', 'ciUpperLimit': '4.28', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '38.89', 'groupDescription': 'Change at Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4242', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '39.5', 'ciLowerLimit': '-24.70', 'ciUpperLimit': '103.65', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '48.33', 'groupDescription': 'Change at Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4295', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-77.2', 'ciLowerLimit': '-225.44', 'ciUpperLimit': '71.01', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '78.61', 'groupDescription': 'Change at Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2272', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-18.7', 'ciLowerLimit': '-38.64', 'ciUpperLimit': '1.20', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '14.97', 'groupDescription': 'Change at Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3416', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-55.1', 'ciLowerLimit': '-135.23', 'ciUpperLimit': '24.95', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '48.90', 'groupDescription': 'Change at Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4192', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '57.6', 'ciLowerLimit': '-35.02', 'ciUpperLimit': '150.19', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '69.75', 'groupDescription': 'Change at Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5245', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-66.8', 'ciLowerLimit': '-231.66', 'ciUpperLimit': '98.02', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '87.42', 'groupDescription': 'Change at Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1988', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-17.8', 'ciLowerLimit': '-35.47', 'ciUpperLimit': '-0.05', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.31', 'groupDescription': 'Change at Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3054', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-69.2', 'ciLowerLimit': '-161.08', 'ciUpperLimit': '22.72', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '56.11', 'groupDescription': 'Change at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5504', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '229.4', 'ciLowerLimit': '-271.51', 'ciUpperLimit': '730.22', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '377.23', 'groupDescription': 'Change at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4493', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-71.2', 'ciLowerLimit': '-214.96', 'ciUpperLimit': '72.65', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '76.27', 'groupDescription': 'Change at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0665', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-40.3', 'ciLowerLimit': '-67.74', 'ciUpperLimit': '-12.85', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '20.63', 'groupDescription': 'Change at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2411', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-78.7', 'ciLowerLimit': '-167.25', 'ciUpperLimit': '9.75', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '54.04', 'groupDescription': 'Change at Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4528', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '60.8', 'ciLowerLimit': '-44.51', 'ciUpperLimit': '166.08', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '79.30', 'groupDescription': 'Change at Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6381', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-41.4', 'ciLowerLimit': '-183.72', 'ciUpperLimit': '100.85', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '75.46', 'groupDescription': 'Change at Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0837', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-31.5', 'ciLowerLimit': '-54.44', 'ciUpperLimit': '-8.62', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '17.22', 'groupDescription': 'Change at Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3428', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-74.7', 'ciLowerLimit': '-183.53', 'ciUpperLimit': '34.13', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '66.45', 'groupDescription': 'Change at Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3533', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '21.8', 'ciLowerLimit': '-8.63', 'ciUpperLimit': '52.27', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '22.93', 'groupDescription': 'Change at Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3755', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-63.9', 'ciLowerLimit': '-170.51', 'ciUpperLimit': '42.66', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '56.53', 'groupDescription': 'Change at Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0268', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-37.6', 'ciLowerLimit': '-58.39', 'ciUpperLimit': '-16.87', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '15.60', 'groupDescription': 'Change at Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1672', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-79.5', 'ciLowerLimit': '-151.20', 'ciUpperLimit': '-7.75', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '43.79', 'groupDescription': 'Change at Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3518', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '43.7', 'ciLowerLimit': '-17.09', 'ciUpperLimit': '104.55', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '45.81', 'groupDescription': 'Change at Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2974', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-68.7', 'ciLowerLimit': '-161.52', 'ciUpperLimit': '24.09', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '49.22', 'groupDescription': 'Change at Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0555', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-38.1', 'ciLowerLimit': '-62.83', 'ciUpperLimit': '-13.33', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '18.60', 'groupDescription': 'Change at Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2614', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-78.3', 'ciLowerLimit': '-171.17', 'ciUpperLimit': '14.62', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '56.72', 'groupDescription': 'Change at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4134', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '31.7', 'ciLowerLimit': '-18.62', 'ciUpperLimit': '81.98', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '37.89', 'groupDescription': 'Change at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2620', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-69.6', 'ciLowerLimit': '-154.44', 'ciUpperLimit': '15.24', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '44.99', 'groupDescription': 'Change at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0269', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-40.2', 'ciLowerLimit': '-62.46', 'ciUpperLimit': '-18.02', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '16.70', 'groupDescription': 'Change at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1709', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-81.2', 'ciLowerLimit': '-155.46', 'ciUpperLimit': '-7.02', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '45.32', 'groupDescription': 'Change at Week 10', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0042', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '42.9', 'ciLowerLimit': '25.61', 'ciUpperLimit': '60.22', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.98', 'groupDescription': 'Change at Week 10', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3772', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-53.2', 'ciLowerLimit': '-142.19', 'ciUpperLimit': '35.88', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '47.22', 'groupDescription': 'Change at Week 10', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0857', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-28.3', 'ciLowerLimit': '-49.06', 'ciUpperLimit': '-7.63', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '15.54', 'groupDescription': 'Change at Week 10', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0607', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-77.3', 'ciLowerLimit': '-120.48', 'ciUpperLimit': '-34.20', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '26.34', 'groupDescription': 'Change at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4862', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '88.8', 'ciLowerLimit': '-77.57', 'ciUpperLimit': '255.22', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '124.79', 'groupDescription': 'Change at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3968', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-53.2', 'ciLowerLimit': '-146.96', 'ciUpperLimit': '40.58', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '49.73', 'groupDescription': 'Change at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1624', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-24.2', 'ciLowerLimit': '-46.31', 'ciUpperLimit': '-2.11', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '16.57', 'groupDescription': 'Change at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1349', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-76.8', 'ciLowerLimit': '-138.58', 'ciUpperLimit': '-14.93', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '37.75', 'groupDescription': 'Change at Week 14', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0525', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '45.5', 'ciLowerLimit': '16.38', 'ciUpperLimit': '74.56', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '21.81', 'groupDescription': 'Change at Week 14', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2719', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-76.6', 'ciLowerLimit': '-172.71', 'ciUpperLimit': '19.55', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '50.98', 'groupDescription': 'Change at Week 14', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0957', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-30.7', 'ciLowerLimit': '-53.86', 'ciUpperLimit': '-7.49', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '17.39', 'groupDescription': 'Change at Week 14', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0942', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-79.8', 'ciLowerLimit': '-133.83', 'ciUpperLimit': '-25.78', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '32.98', 'groupDescription': 'Change at Week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1606', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '34.6', 'ciLowerLimit': '3.16', 'ciUpperLimit': '66.09', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '23.60', 'groupDescription': 'Change at Week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2096', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-77.0', 'ciLowerLimit': '-156.58', 'ciUpperLimit': '2.58', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '42.20', 'groupDescription': 'Change at Week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1279', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-29.3', 'ciLowerLimit': '-53.74', 'ciUpperLimit': '-4.89', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '18.32', 'groupDescription': 'Change at Week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0479', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-75.0', 'ciLowerLimit': '-112.96', 'ciUpperLimit': '-37.08', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '23.17', 'groupDescription': 'Change at Week 18', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1700', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '32.8', 'ciLowerLimit': '2.28', 'ciUpperLimit': '63.37', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '22.91', 'groupDescription': 'Change at Week 18', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1142', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-80.1', 'ciLowerLimit': '-136.03', 'ciUpperLimit': '-24.15', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '29.67', 'groupDescription': 'Change at Week 18', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3980', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-18.0', 'ciLowerLimit': '-45.80', 'ciUpperLimit': '9.71', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '20.82', 'groupDescription': 'Change at Week 18', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 1-8, 10, 12, 14, 16, 18', 'description': 'Participants were asked to place a line perpendicular to the VAS line at the point that represents the intensity of their average sleeplessness experienced over the previous 3 nights using a scale from 0 to 10, with 0 indicating no sleeplessness and 10 indicating the worst imaginable sleeplessness at every visit.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'KPL-716: CIU Cohort', 'description': 'Participants with CIU received KPL-716 weekly for 8 weeks'}, {'id': 'OG001', 'title': 'Placebo: CIU Cohort', 'description': 'Participants with CIU received placebo weekly for 8 weeks'}, {'id': 'OG002', 'title': 'KPL-716: CIP Cohort', 'description': 'Participants with CIP received KPL-716 weekly for 8 weeks'}, {'id': 'OG003', 'title': 'Placebo: CIP Cohort', 'description': 'Participants with CIP received placebo weekly for 8 weeks'}, {'id': 'OG004', 'title': 'KPL-716: LP Cohort', 'description': 'Participants with LP received KPL-716 weekly for 8 weeks'}, {'id': 'OG005', 'title': 'Placebo: LP Cohort', 'description': 'Participants with LP received placebo weekly for 8 weeks'}, {'id': 'OG006', 'title': 'KPL-716: LSC Cohort', 'description': 'Participants with LSC received KPL-716 weekly for 8 weeks'}, {'id': 'OG007', 'title': 'Placebo: LSC Cohort', 'description': 'Participants with LSC received placebo weekly for 8 weeks'}, {'id': 'OG008', 'title': 'KPL-716: PPs Cohort', 'description': 'Participants with PPs received KPL-716 weekly for 8 weeks'}, {'id': 'OG009', 'title': 'Placebo: PPs Cohort', 'description': 'Participants with PPs received placebo weekly for 8 weeks'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.29', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '0.44', 'groupId': 'OG002'}, {'value': '-1.7', 'spread': '0.40', 'groupId': 'OG003'}, {'value': '-0.3', 'spread': '0.08', 'groupId': 'OG004'}, {'value': '-3.0', 'spread': '1.31', 'groupId': 'OG006'}, {'value': '-1.0', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-0.7', 'spread': '0.16', 'groupId': 'OG008'}, {'value': '0.0', 'spread': '0.24', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.43', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': '0.52', 'groupId': 'OG002'}, {'value': '-3.1', 'spread': '0.57', 'groupId': 'OG003'}, {'value': '-0.9', 'spread': '0.30', 'groupId': 'OG004'}, {'value': '-4.3', 'spread': '1.96', 'groupId': 'OG006'}, {'value': '-1.0', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-1.3', 'spread': '0.26', 'groupId': 'OG008'}, {'value': '-0.6', 'spread': '0.35', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-4.2', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '-2.6', 'spread': '0.59', 'groupId': 'OG002'}, {'value': '-2.9', 'spread': '0.70', 'groupId': 'OG003'}, {'value': '-1.6', 'spread': '0.87', 'groupId': 'OG004'}, {'value': '-4.6', 'spread': '2.10', 'groupId': 'OG006'}, {'value': '-1.6', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-2.4', 'spread': '0.56', 'groupId': 'OG008'}, {'value': '-0.8', 'spread': '0.42', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-4.5', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '-2.7', 'spread': '0.72', 'groupId': 'OG002'}, {'value': '-2.9', 'spread': '0.82', 'groupId': 'OG003'}, {'value': '-2.5', 'spread': '1.57', 'groupId': 'OG004'}, {'value': '-4.8', 'spread': '1.91', 'groupId': 'OG006'}, {'value': '-2.1', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-3.1', 'spread': '0.55', 'groupId': 'OG008'}, {'value': '-1.0', 'spread': '0.70', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-5.0', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.43', 'groupId': 'OG001'}, {'value': '-3.0', 'spread': '0.76', 'groupId': 'OG002'}, {'value': '-3.0', 'spread': '0.71', 'groupId': 'OG003'}, {'value': '-2.9', 'spread': '1.64', 'groupId': 'OG004'}, {'value': '-5.2', 'spread': '1.95', 'groupId': 'OG006'}, {'value': '-2.0', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-4.1', 'spread': '0.72', 'groupId': 'OG008'}, {'value': '-1.5', 'spread': '0.89', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-5.0', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '-3.0', 'spread': '0.69', 'groupId': 'OG002'}, {'value': '-3.8', 'spread': '0.71', 'groupId': 'OG003'}, {'value': '-3.1', 'spread': '1.61', 'groupId': 'OG004'}, {'value': '-5.5', 'spread': '1.82', 'groupId': 'OG006'}, {'value': '-2.6', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-4.4', 'spread': '0.69', 'groupId': 'OG008'}, {'value': '-1.4', 'spread': '0.90', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-4.5', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.21', 'groupId': 'OG001'}, {'value': '-3.0', 'spread': '0.65', 'groupId': 'OG002'}, {'value': '-3.7', 'spread': '0.75', 'groupId': 'OG003'}, {'value': '-3.6', 'spread': '1.65', 'groupId': 'OG004'}, {'value': '-5.6', 'spread': '1.76', 'groupId': 'OG006'}, {'value': '-2.6', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-4.8', 'spread': '0.72', 'groupId': 'OG008'}, {'value': '-1.8', 'spread': '1.08', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-3.8', 'spread': '1.66', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.29', 'groupId': 'OG001'}, {'value': '-3.2', 'spread': '0.64', 'groupId': 'OG002'}, {'value': '-2.9', 'spread': '0.81', 'groupId': 'OG003'}, {'value': '-3.6', 'spread': '1.65', 'groupId': 'OG004'}, {'value': '-5.4', 'spread': '1.94', 'groupId': 'OG006'}, {'value': '-3.3', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-5.2', 'spread': '0.70', 'groupId': 'OG008'}, {'value': '-2.1', 'spread': '1.21', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-4.4', 'spread': '1.46', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.71', 'groupId': 'OG001'}, {'value': '-2.9', 'spread': '0.69', 'groupId': 'OG002'}, {'value': '-3.7', 'spread': '0.65', 'groupId': 'OG003'}, {'value': '-5.1', 'spread': '0.86', 'groupId': 'OG004'}, {'value': '-5.4', 'spread': '1.88', 'groupId': 'OG006'}, {'value': '-3.4', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-5.3', 'spread': '0.70', 'groupId': 'OG008'}, {'value': '-2.4', 'spread': '1.27', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-4.4', 'spread': '1.64', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '-2.6', 'spread': '0.65', 'groupId': 'OG002'}, {'value': '-4.5', 'spread': '0.55', 'groupId': 'OG003'}, {'value': '-5.1', 'spread': '0.86', 'groupId': 'OG004'}, {'value': '-5.6', 'spread': '1.69', 'groupId': 'OG006'}, {'value': '-3.0', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-5.2', 'spread': '0.77', 'groupId': 'OG008'}, {'value': '-2.4', 'spread': '1.21', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-4.7', 'spread': '1.78', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '-2.6', 'spread': '0.76', 'groupId': 'OG002'}, {'value': '-4.6', 'spread': '0.69', 'groupId': 'OG003'}, {'value': '-5.1', 'spread': '0.86', 'groupId': 'OG004'}, {'value': '-5.7', 'spread': '1.61', 'groupId': 'OG006'}, {'value': '-3.1', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-5.0', 'spread': '0.77', 'groupId': 'OG008'}, {'value': '-2.4', 'spread': '1.20', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-4.7', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '-2.5', 'spread': '0.73', 'groupId': 'OG002'}, {'value': '-4.1', 'spread': '0.71', 'groupId': 'OG003'}, {'value': '-5.1', 'spread': '0.86', 'groupId': 'OG004'}, {'value': '-5.9', 'spread': '1.50', 'groupId': 'OG006'}, {'value': '-2.6', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-4.9', 'spread': '0.78', 'groupId': 'OG008'}, {'value': '-2.5', 'spread': '1.17', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-4.1', 'spread': '1.90', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '-2.5', 'spread': '0.65', 'groupId': 'OG002'}, {'value': '-4.3', 'spread': '0.73', 'groupId': 'OG003'}, {'value': '-5.6', 'spread': '0.43', 'groupId': 'OG004'}, {'value': '-5.9', 'spread': '1.53', 'groupId': 'OG006'}, {'value': '-1.9', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-5.0', 'spread': '0.80', 'groupId': 'OG008'}, {'value': '-2.5', 'spread': '1.18', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-3.6', 'spread': '1.92', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '-2.8', 'spread': '0.65', 'groupId': 'OG002'}, {'value': '-4.3', 'spread': '0.78', 'groupId': 'OG003'}, {'value': '-5.6', 'spread': '0.36', 'groupId': 'OG004'}, {'value': '-5.8', 'spread': '1.58', 'groupId': 'OG006'}, {'value': '-2.1', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-5.1', 'spread': '0.78', 'groupId': 'OG008'}, {'value': '-2.6', 'spread': '1.20', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-4.4', 'spread': '1.77', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '-2.6', 'spread': '0.61', 'groupId': 'OG002'}, {'value': '-4.1', 'spread': '0.73', 'groupId': 'OG003'}, {'value': '-5.6', 'spread': '0.36', 'groupId': 'OG004'}, {'value': '-6.0', 'spread': '1.45', 'groupId': 'OG006'}, {'value': '-2.4', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-5.0', 'spread': '0.83', 'groupId': 'OG008'}, {'value': '-2.8', 'spread': '1.35', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-4.1', 'spread': '1.86', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '-2.8', 'spread': '0.68', 'groupId': 'OG002'}, {'value': '-3.8', 'spread': '0.91', 'groupId': 'OG003'}, {'value': '-5.6', 'spread': '0.36', 'groupId': 'OG004'}, {'value': '-6.0', 'spread': '1.43', 'groupId': 'OG006'}, {'value': '-1.9', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-4.9', 'spread': '0.81', 'groupId': 'OG008'}, {'value': '-2.7', 'spread': '1.32', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-4.2', 'spread': '1.91', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '-2.7', 'spread': '0.64', 'groupId': 'OG002'}, {'value': '-3.5', 'spread': '0.85', 'groupId': 'OG003'}, {'value': '-5.6', 'spread': '0.36', 'groupId': 'OG004'}, {'value': '-6.2', 'spread': '1.32', 'groupId': 'OG006'}, {'value': '-1.4', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-4.6', 'spread': '0.97', 'groupId': 'OG008'}, {'value': '-3.0', 'spread': '1.37', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-4.4', 'spread': '1.79', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '-2.8', 'spread': '0.72', 'groupId': 'OG002'}, {'value': '-3.6', 'spread': '0.92', 'groupId': 'OG003'}, {'value': '-5.7', 'spread': '0.43', 'groupId': 'OG004'}, {'value': '-6.2', 'spread': '1.32', 'groupId': 'OG006'}, {'value': '-1.3', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-4.6', 'spread': '0.98', 'groupId': 'OG008'}, {'value': '-3.0', 'spread': '1.36', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 1-18', 'description': 'Participants were asked daily to assign a numerical score to the intensity of their difficulty falling asleep last night due to itch using a scale from 0 to 10, with 0 indicating not difficult at all and 10 indicating extremely difficult.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'KPL-716: CIU Cohort', 'description': 'Participants with CIU received KPL-716 weekly for 8 weeks'}, {'id': 'OG001', 'title': 'Placebo: CIU Cohort', 'description': 'Participants with CIU received placebo weekly for 8 weeks'}, {'id': 'OG002', 'title': 'KPL-716: CIP Cohort', 'description': 'Participants with CIP received KPL-716 weekly for 8 weeks'}, {'id': 'OG003', 'title': 'Placebo: CIP Cohort', 'description': 'Participants with CIP received placebo weekly for 8 weeks'}, {'id': 'OG004', 'title': 'KPL-716: LP Cohort', 'description': 'Participants with LP received KPL-716 weekly for 8 weeks'}, {'id': 'OG005', 'title': 'Placebo: LP Cohort', 'description': 'Participants with LP received placebo weekly for 8 weeks'}, {'id': 'OG006', 'title': 'KPL-716: LSC Cohort', 'description': 'Participants with LSC received KPL-716 weekly for 8 weeks'}, {'id': 'OG007', 'title': 'Placebo: LSC Cohort', 'description': 'Participants with LSC received placebo weekly for 8 weeks'}, {'id': 'OG008', 'title': 'KPL-716: PPs Cohort', 'description': 'Participants with PPs received KPL-716 weekly for 8 weeks'}, {'id': 'OG009', 'title': 'Placebo: PPs Cohort', 'description': 'Participants with PPs received placebo weekly for 8 weeks'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-35.3', 'spread': '9.68', 'groupId': 'OG000'}, {'value': '-22.2', 'spread': '13.83', 'groupId': 'OG001'}, {'value': '-4.9', 'spread': '8.21', 'groupId': 'OG002'}, {'value': '-26.6', 'spread': '9.88', 'groupId': 'OG003'}, {'value': '-3.6', 'spread': '1.17', 'groupId': 'OG004'}, {'value': '-42.9', 'spread': '17.69', 'groupId': 'OG006'}, {'value': '-7.4', 'spread': '36.83', 'groupId': 'OG007'}, {'value': '-9.3', 'spread': '2.32', 'groupId': 'OG008'}, {'value': '1.2', 'spread': '3.33', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-51.1', 'spread': '13.32', 'groupId': 'OG000'}, {'value': '-34.9', 'spread': '19.03', 'groupId': 'OG001'}, {'value': '-31.2', 'spread': '7.80', 'groupId': 'OG002'}, {'value': '-48.7', 'spread': '9.38', 'groupId': 'OG003'}, {'value': '-10.9', 'spread': '5.13', 'groupId': 'OG004'}, {'value': '-59.3', 'spread': '23.10', 'groupId': 'OG006'}, {'value': '-0.5', 'spread': '48.09', 'groupId': 'OG007'}, {'value': '-15.0', 'spread': '3.50', 'groupId': 'OG008'}, {'value': '-9.3', 'spread': '5.03', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-63.9', 'spread': '20.16', 'groupId': 'OG000'}, {'value': '-40.9', 'spread': '28.80', 'groupId': 'OG001'}, {'value': '-42.1', 'spread': '8.81', 'groupId': 'OG002'}, {'value': '-48.7', 'spread': '10.60', 'groupId': 'OG003'}, {'value': '-20.0', 'spread': '15.28', 'groupId': 'OG004'}, {'value': '-64.8', 'spread': '24.87', 'groupId': 'OG006'}, {'value': '-6.2', 'spread': '51.77', 'groupId': 'OG007'}, {'value': '-27.6', 'spread': '6.38', 'groupId': 'OG008'}, {'value': '-11.2', 'spread': '9.16', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-61.0', 'spread': '15.91', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '22.72', 'groupId': 'OG001'}, {'value': '-43.3', 'spread': '10.71', 'groupId': 'OG002'}, {'value': '-50.3', 'spread': '12.88', 'groupId': 'OG003'}, {'value': '-31.4', 'spread': '27.58', 'groupId': 'OG004'}, {'value': '-67.6', 'spread': '21.14', 'groupId': 'OG006'}, {'value': '-14.2', 'spread': '44.00', 'groupId': 'OG007'}, {'value': '-36.3', 'spread': '6.64', 'groupId': 'OG008'}, {'value': '-12.2', 'spread': '9.53', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-71.7', 'spread': '22.82', 'groupId': 'OG000'}, {'value': '-36.4', 'spread': '32.59', 'groupId': 'OG001'}, {'value': '-46.0', 'spread': '11.47', 'groupId': 'OG002'}, {'value': '-50.4', 'spread': '13.80', 'groupId': 'OG003'}, {'value': '-37.2', 'spread': '28.02', 'groupId': 'OG004'}, {'value': '-73.1', 'spread': '23.65', 'groupId': 'OG006'}, {'value': '-15.4', 'spread': '49.24', 'groupId': 'OG007'}, {'value': '-48.4', 'spread': '7.51', 'groupId': 'OG008'}, {'value': '-20.8', 'spread': '10.78', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-73.1', 'spread': '21.37', 'groupId': 'OG000'}, {'value': '-42.1', 'spread': '30.52', 'groupId': 'OG001'}, {'value': '-47.5', 'spread': '9.49', 'groupId': 'OG002'}, {'value': '-60.6', 'spread': '11.42', 'groupId': 'OG003'}, {'value': '-39.8', 'spread': '26.65', 'groupId': 'OG004'}, {'value': '-79.0', 'spread': '25.98', 'groupId': 'OG006'}, {'value': '-30.3', 'spread': '54.08', 'groupId': 'OG007'}, {'value': '-52.7', 'spread': '7.40', 'groupId': 'OG008'}, {'value': '-19.0', 'spread': '10.63', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-62.2', 'spread': '19.51', 'groupId': 'OG000'}, {'value': '-19.4', 'spread': '27.88', 'groupId': 'OG001'}, {'value': '-50.5', 'spread': '8.27', 'groupId': 'OG002'}, {'value': '-61.5', 'spread': '9.95', 'groupId': 'OG003'}, {'value': '-46.3', 'spread': '23.22', 'groupId': 'OG004'}, {'value': '-80.0', 'spread': '24.71', 'groupId': 'OG006'}, {'value': '-30.3', 'spread': '51.45', 'groupId': 'OG007'}, {'value': '-57.2', 'spread': '8.21', 'groupId': 'OG008'}, {'value': '-24.5', 'spread': '11.79', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-51.9', 'spread': '21.00', 'groupId': 'OG000'}, {'value': '-25.8', 'spread': '30.00', 'groupId': 'OG001'}, {'value': '-54.1', 'spread': '8.75', 'groupId': 'OG002'}, {'value': '-47.9', 'spread': '10.52', 'groupId': 'OG003'}, {'value': '-46.3', 'spread': '23.22', 'groupId': 'OG004'}, {'value': '-77.0', 'spread': '28.52', 'groupId': 'OG006'}, {'value': '-38.6', 'spread': '59.36', 'groupId': 'OG007'}, {'value': '-63.2', 'spread': '8.55', 'groupId': 'OG008'}, {'value': '-27.5', 'spread': '12.29', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-52.4', 'spread': '10.60', 'groupId': 'OG000'}, {'value': '55.9', 'spread': '15.15', 'groupId': 'OG001'}, {'value': '-50.6', 'spread': '8.32', 'groupId': 'OG002'}, {'value': '-60.6', 'spread': '9.20', 'groupId': 'OG003'}, {'value': '-66.9', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-78.0', 'spread': '27.25', 'groupId': 'OG006'}, {'value': '-40.3', 'spread': '56.72', 'groupId': 'OG007'}, {'value': '-64.3', 'spread': '8.48', 'groupId': 'OG008'}, {'value': '-32.3', 'spread': '12.17', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-62.3', 'spread': '22.58', 'groupId': 'OG000'}, {'value': '-43.1', 'spread': '32.26', 'groupId': 'OG001'}, {'value': '-45.5', 'spread': '7.86', 'groupId': 'OG002'}, {'value': '-69.4', 'spread': '8.70', 'groupId': 'OG003'}, {'value': '-66.9', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-80.6', 'spread': '23.28', 'groupId': 'OG006'}, {'value': '-35.5', 'spread': '48.46', 'groupId': 'OG007'}, {'value': '-62.0', 'spread': '8.70', 'groupId': 'OG008'}, {'value': '-31.5', 'spread': '12.50', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-66.4', 'spread': '24.89', 'groupId': 'OG000'}, {'value': '-43.1', 'spread': '35.55', 'groupId': 'OG001'}, {'value': '-43.2', 'spread': '9.82', 'groupId': 'OG002'}, {'value': '-69.8', 'spread': '10.86', 'groupId': 'OG003'}, {'value': '-66.9', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-82.1', 'spread': '21.38', 'groupId': 'OG006'}, {'value': '-37.1', 'spread': '44.50', 'groupId': 'OG007'}, {'value': '-58.9', 'spread': '8.47', 'groupId': 'OG008'}, {'value': '-33.2', 'spread': '12.17', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-66.4', 'spread': '23.94', 'groupId': 'OG000'}, {'value': '-43.1', 'spread': '34.20', 'groupId': 'OG001'}, {'value': '-43.4', 'spread': '10.02', 'groupId': 'OG002'}, {'value': '-64.0', 'spread': '11.08', 'groupId': 'OG003'}, {'value': '-66.9', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-85.2', 'spread': '18.38', 'groupId': 'OG006'}, {'value': '-30.2', 'spread': '38.26', 'groupId': 'OG007'}, {'value': '-58.5', 'spread': '8.78', 'groupId': 'OG008'}, {'value': '-33.7', 'spread': '12.60', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-55.7', 'spread': '26.31', 'groupId': 'OG000'}, {'value': '-43.7', 'spread': '37.59', 'groupId': 'OG001'}, {'value': '-43.5', 'spread': '9.52', 'groupId': 'OG002'}, {'value': '-68.2', 'spread': '10.53', 'groupId': 'OG003'}, {'value': '-72.8', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-84.6', 'spread': '19.01', 'groupId': 'OG006'}, {'value': '-21.9', 'spread': '39.57', 'groupId': 'OG007'}, {'value': '-60.6', 'spread': '9.18', 'groupId': 'OG008'}, {'value': '-34.1', 'spread': '13.19', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-48.5', 'spread': '25.78', 'groupId': 'OG000'}, {'value': '-44.0', 'spread': '36.83', 'groupId': 'OG001'}, {'value': '-49.4', 'spread': '9.01', 'groupId': 'OG002'}, {'value': '-68.9', 'spread': '9.97', 'groupId': 'OG003'}, {'value': '-73.8', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-83.6', 'spread': '20.28', 'groupId': 'OG006'}, {'value': '-25.2', 'spread': '42.21', 'groupId': 'OG007'}, {'value': '-61.7', 'spread': '9.25', 'groupId': 'OG008'}, {'value': '-34.1', 'spread': '13.28', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-62.3', 'spread': '24.47', 'groupId': 'OG000'}, {'value': '-43.3', 'spread': '34.96', 'groupId': 'OG001'}, {'value': '-44.1', 'spread': '8.74', 'groupId': 'OG002'}, {'value': '-67.0', 'spread': '9.67', 'groupId': 'OG003'}, {'value': '-73.8', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-86.2', 'spread': '17.11', 'groupId': 'OG006'}, {'value': '-28.5', 'spread': '35.62', 'groupId': 'OG007'}, {'value': '-60.2', 'spread': '9.90', 'groupId': 'OG008'}, {'value': '-38.3', 'spread': '14.22', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-56.4', 'spread': '25.57', 'groupId': 'OG000'}, {'value': '-43.7', 'spread': '36.52', 'groupId': 'OG001'}, {'value': '-47.8', 'spread': '10.02', 'groupId': 'OG002'}, {'value': '-64.3', 'spread': '11.08', 'groupId': 'OG003'}, {'value': '-73.8', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-86.7', 'spread': '16.48', 'groupId': 'OG006'}, {'value': '-21.8', 'spread': '34.30', 'groupId': 'OG007'}, {'value': '-58.9', 'spread': '9.71', 'groupId': 'OG008'}, {'value': '-37.0', 'spread': '13.95', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-58.5', 'spread': '26.89', 'groupId': 'OG000'}, {'value': '-43.6', 'spread': '38.41', 'groupId': 'OG001'}, {'value': '-45.1', 'spread': '9.46', 'groupId': 'OG002'}, {'value': '-60.3', 'spread': '10.47', 'groupId': 'OG003'}, {'value': '-73.8', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-89.3', 'spread': '13.31', 'groupId': 'OG006'}, {'value': '-16.8', 'spread': '27.70', 'groupId': 'OG007'}, {'value': '-53.7', 'spread': '11.52', 'groupId': 'OG008'}, {'value': '-41.2', 'spread': '16.54', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-61.1', 'spread': '24.70', 'groupId': 'OG000'}, {'value': '-43.4', 'spread': '35.29', 'groupId': 'OG001'}, {'value': '-48.1', 'spread': '10.22', 'groupId': 'OG002'}, {'value': '-61.9', 'spread': '11.30', 'groupId': 'OG003'}, {'value': '-74.7', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-89.3', 'spread': '13.31', 'groupId': 'OG006'}, {'value': '-15.1', 'spread': '27.70', 'groupId': 'OG007'}, {'value': '-53.4', 'spread': '11.61', 'groupId': 'OG008'}, {'value': '-41.8', 'spread': '16.68', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '0.4979', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-13.2', 'ciLowerLimit': '-41.17', 'ciUpperLimit': '14.86', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '17.11', 'groupDescription': 'Change at Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1079', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '21.7', 'ciLowerLimit': '4.63', 'ciUpperLimit': '38.83', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.88', 'groupDescription': 'Change at Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4837', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-35.6', 'ciLowerLimit': '-114.19', 'ciUpperLimit': '43.07', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '41.70', 'groupDescription': 'Change at Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0208', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-10.5', 'ciLowerLimit': '-15.99', 'ciUpperLimit': '-4.98', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.14', 'groupDescription': 'Change at Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5413', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-16.2', 'ciLowerLimit': '-54.74', 'ciUpperLimit': '22.38', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '23.54', 'groupDescription': 'Change at Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1683', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '17.5', 'ciLowerLimit': '1.28', 'ciUpperLimit': '33.74', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.22', 'groupDescription': 'Change at Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3933', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-58.8', 'ciLowerLimit': '-161.43', 'ciUpperLimit': '43.89', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '54.45', 'groupDescription': 'Change at Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3705', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-5.7', 'ciLowerLimit': '-14.06', 'ciUpperLimit': '2.58', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.25', 'groupDescription': 'Change at Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5644', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-23.0', 'ciLowerLimit': '-81.36', 'ciUpperLimit': '35.34', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '35.63', 'groupDescription': 'Change at Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6384', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '6.6', 'ciLowerLimit': '-11.75', 'ciUpperLimit': '24.94', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.82', 'groupDescription': 'Change at Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4229', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-58.6', 'ciLowerLimit': '-169.13', 'ciUpperLimit': '51.95', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '58.62', 'groupDescription': 'Change at Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1688', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-16.3', 'ciLowerLimit': '-31.47', 'ciUpperLimit': '-1.18', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.38', 'groupDescription': 'Change at Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1243', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-59.6', 'ciLowerLimit': '-105.59', 'ciUpperLimit': '-13.53', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '28.11', 'groupDescription': 'Change at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6841', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '6.9', 'ciLowerLimit': '-15.35', 'ciUpperLimit': '29.22', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '16.79', 'groupDescription': 'Change at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3963', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-53.4', 'ciLowerLimit': '-147.31', 'ciUpperLimit': '40.59', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '49.83', 'groupDescription': 'Change at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0571', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-24.1', 'ciLowerLimit': '-39.85', 'ciUpperLimit': '-8.32', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.85', 'groupDescription': 'Change at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4457', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-35.3', 'ciLowerLimit': '-101.32', 'ciUpperLimit': '30.73', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '40.32', 'groupDescription': 'Change at Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8075', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '4.4', 'ciLowerLimit': '-19.44', 'ciUpperLimit': '28.32', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '17.99', 'groupDescription': 'Change at Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4093', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-57.7', 'ciLowerLimit': '-162.84', 'ciUpperLimit': '47.40', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '55.75', 'groupDescription': 'Change at Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0543', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-27.6', 'ciLowerLimit': '-45.42', 'ciUpperLimit': '-9.76', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.40', 'groupDescription': 'Change at Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4711', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-31.0', 'ciLowerLimit': '-92.88', 'ciUpperLimit': '30.78', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '37.75', 'groupDescription': 'Change at Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3925', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '13.0', 'ciLowerLimit': '-6.74', 'ciUpperLimit': '32.79', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '14.89', 'groupDescription': 'Change at Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5095', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-48.7', 'ciLowerLimit': '-164.22', 'ciUpperLimit': '66.72', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '61.24', 'groupDescription': 'Change at Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0199', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-33.8', 'ciLowerLimit': '-51.35', 'ciUpperLimit': '-16.18', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.22', 'groupDescription': 'Change at Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3029', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-42.8', 'ciLowerLimit': '-99.26', 'ciUpperLimit': '13.69', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '34.48', 'groupDescription': 'Change at Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4094', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '10.9', 'ciLowerLimit': '-6.28', 'ciUpperLimit': '28.16', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.97', 'groupDescription': 'Change at Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4828', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-49.8', 'ciLowerLimit': '-159.63', 'ciUpperLimit': '60.05', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '58.25', 'groupDescription': 'Change at Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0383', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-32.8', 'ciLowerLimit': '-52.26', 'ciUpperLimit': '-13.26', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '14.66', 'groupDescription': 'Change at Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5322', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-26.1', 'ciLowerLimit': '-86.66', 'ciUpperLimit': '34.65', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '37.10', 'groupDescription': 'Change at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6577', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-6.2', 'ciLowerLimit': '-24.38', 'ciUpperLimit': '12.03', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.71', 'groupDescription': 'Change at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6259', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-38.3', 'ciLowerLimit': '-165.08', 'ciUpperLimit': '88.40', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '67.21', 'groupDescription': 'Change at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0312', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-35.7', 'ciLowerLimit': '-56.01', 'ciUpperLimit': '-15.38', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '15.27', 'groupDescription': 'Change at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0103', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-108.3', 'ciLowerLimit': '-138.97', 'ciUpperLimit': '-77.61', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '18.73', 'groupDescription': 'Change at Week 9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4330', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '10.0', 'ciLowerLimit': '-6.59', 'ciUpperLimit': '26.56', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.43', 'groupDescription': 'Change at Week 9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6165', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-37.7', 'ciLowerLimit': '-158.82', 'ciUpperLimit': '83.39', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '64.23', 'groupDescription': 'Change at Week 9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0488', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-32.0', 'ciLowerLimit': '-52.11', 'ciUpperLimit': '-11.84', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '15.13', 'groupDescription': 'Change at Week 9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6636', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-19.2', 'ciLowerLimit': '-84.53', 'ciUpperLimit': '46.16', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '39.90', 'groupDescription': 'Change at Week 10', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0583', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '23.9', 'ciLowerLimit': '8.18', 'ciUpperLimit': '39.52', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.75', 'groupDescription': 'Change at Week 10', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4975', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-45.1', 'ciLowerLimit': '-148.55', 'ciUpperLimit': '58.36', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '54.87', 'groupDescription': 'Change at Week 10', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0653', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-30.5', 'ciLowerLimit': '-51.17', 'ciUpperLimit': '-9.82', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '15.54', 'groupDescription': 'Change at Week 10', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6316', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-23.4', 'ciLowerLimit': '-95.42', 'ciUpperLimit': '48.62', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '43.98', 'groupDescription': 'Change at Week 11', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0874', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '26.6', 'ciLowerLimit': '7.05', 'ciUpperLimit': '46.18', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '14.68', 'groupDescription': 'Change at Week 11', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4662', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-45.0', 'ciLowerLimit': '-139.99', 'ciUpperLimit': '50.03', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '50.39', 'groupDescription': 'Change at Week 11', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1073', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-25.6', 'ciLowerLimit': '-45.76', 'ciUpperLimit': '-5.51', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '15.12', 'groupDescription': 'Change at Week 11', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6197', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-23.3', 'ciLowerLimit': '-92.62', 'ciUpperLimit': '45.96', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '42.31', 'groupDescription': 'Change at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1868', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '20.6', 'ciLowerLimit': '0.63', 'ciUpperLimit': '40.55', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '14.97', 'groupDescription': 'Change at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3321', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-55.0', 'ciLowerLimit': '-136.65', 'ciUpperLimit': '26.71', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '43.32', 'groupDescription': 'Change at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1310', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-24.8', 'ciLowerLimit': '-45.64', 'ciUpperLimit': '-3.95', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '15.67', 'groupDescription': 'Change at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8128', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-12.0', 'ciLowerLimit': '-88.15', 'ciUpperLimit': '64.13', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '46.49', 'groupDescription': 'Change at Week 13', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1004', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '24.7', 'ciLowerLimit': '5.75', 'ciUpperLimit': '43.69', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '14.23', 'groupDescription': 'Change at Week 13', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2962', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-62.8', 'ciLowerLimit': '-147.28', 'ciUpperLimit': '21.71', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '44.81', 'groupDescription': 'Change at Week 13', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1236', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-26.5', 'ciLowerLimit': '-48.31', 'ciUpperLimit': '-4.67', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '16.40', 'groupDescription': 'Change at Week 13', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9276', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-4.5', 'ciLowerLimit': '-79.10', 'ciUpperLimit': '70.11', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '45.55', 'groupDescription': 'Change at Week 14', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1657', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '19.5', 'ciLowerLimit': '1.55', 'ciUpperLimit': '37.45', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.46', 'groupDescription': 'Change at Week 14', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3461', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-58.4', 'ciLowerLimit': '-148.54', 'ciUpperLimit': '31.71', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '47.80', 'groupDescription': 'Change at Week 14', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1118', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-27.6', 'ciLowerLimit': '-49.58', 'ciUpperLimit': '-5.64', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '16.51', 'groupDescription': 'Change at Week 14', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6912', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-18.9', 'ciLowerLimit': '-89.75', 'ciUpperLimit': '51.89', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '43.24', 'groupDescription': 'Change at Week 15', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0973', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '22.9', 'ciLowerLimit': '5.50', 'ciUpperLimit': '40.35', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.07', 'groupDescription': 'Change at Week 15', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2890', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-57.7', 'ciLowerLimit': '-133.72', 'ciUpperLimit': '18.37', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '40.33', 'groupDescription': 'Change at Week 15', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2310', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-21.9', 'ciLowerLimit': '-45.43', 'ciUpperLimit': '1.60', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '17.68', 'groupDescription': 'Change at Week 15', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7967', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-12.7', 'ciLowerLimit': '-86.69', 'ciUpperLimit': '61.28', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '45.17', 'groupDescription': 'Change at Week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2868', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '16.5', 'ciLowerLimit': '-3.50', 'ciUpperLimit': '36.44', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '14.98', 'groupDescription': 'Change at Week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2369', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-64.9', 'ciLowerLimit': '-138.08', 'ciUpperLimit': '8.37', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '38.83', 'groupDescription': 'Change at Week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2228', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-21.9', 'ciLowerLimit': '-44.97', 'ciUpperLimit': '1.17', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '17.34', 'groupDescription': 'Change at Week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7740', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-14.9', 'ciLowerLimit': '-92.74', 'ciUpperLimit': '62.89', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '47.51', 'groupDescription': 'Change at Week 17', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3000', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '15.1', 'ciLowerLimit': '-3.74', 'ciUpperLimit': '33.98', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '14.14', 'groupDescription': 'Change at Week 17', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1472', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-72.4', 'ciLowerLimit': '-131.59', 'ciUpperLimit': '-13.30', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '31.37', 'groupDescription': 'Change at Week 17', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5536', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-12.4', 'ciLowerLimit': '-39.77', 'ciUpperLimit': '14.94', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '20.56', 'groupDescription': 'Change at Week 17', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7131', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-17.6', 'ciLowerLimit': '-89.13', 'ciUpperLimit': '53.84', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '43.65', 'groupDescription': 'Change at Week 18', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3762', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '13.9', 'ciLowerLimit': '-6.49', 'ciUpperLimit': '34.24', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '15.27', 'groupDescription': 'Change at Week 18', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1419', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-74.1', 'ciLowerLimit': '-133.26', 'ciUpperLimit': '-14.97', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '31.37', 'groupDescription': 'Change at Week 18', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5817', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-11.6', 'ciLowerLimit': '-39.22', 'ciUpperLimit': '15.95', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '20.74', 'groupDescription': 'Change at Week 18', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 1-18', 'description': 'Participants were asked daily to assign a numerical score to the intensity of their difficulty falling asleep last night due to itch using a scale from 0 to 10, with 0 indicating not difficult at all and 10 indicating extremely difficult.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Weekly Average of Sleep Quality NRS Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'KPL-716: CIU Cohort', 'description': 'Participants with CIU received KPL-716 weekly for 8 weeks'}, {'id': 'OG001', 'title': 'Placebo: CIU Cohort', 'description': 'Participants with CIU received placebo weekly for 8 weeks'}, {'id': 'OG002', 'title': 'KPL-716: CIP Cohort', 'description': 'Participants with CIP received KPL-716 weekly for 8 weeks'}, {'id': 'OG003', 'title': 'Placebo: CIP Cohort', 'description': 'Participants with CIP received placebo weekly for 8 weeks'}, {'id': 'OG004', 'title': 'KPL-716: LP Cohort', 'description': 'Participants with LP received KPL-716 weekly for 8 weeks'}, {'id': 'OG005', 'title': 'Placebo: LP Cohort', 'description': 'Participants with LP received placebo weekly for 8 weeks'}, {'id': 'OG006', 'title': 'KPL-716: LSC Cohort', 'description': 'Participants with LSC received KPL-716 weekly for 8 weeks'}, {'id': 'OG007', 'title': 'Placebo: LSC Cohort', 'description': 'Participants with LSC received placebo weekly for 8 weeks'}, {'id': 'OG008', 'title': 'KPL-716: PPs Cohort', 'description': 'Participants with PPs received KPL-716 weekly for 8 weeks'}, {'id': 'OG009', 'title': 'Placebo: PPs Cohort', 'description': 'Participants with PPs received placebo weekly for 8 weeks'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.29', 'groupId': 'OG001'}, {'value': '-0.2', 'spread': '0.33', 'groupId': 'OG002'}, {'value': '-1.6', 'spread': '0.43', 'groupId': 'OG003'}, {'value': '-0.2', 'spread': '0.17', 'groupId': 'OG004'}, {'value': '-2.6', 'spread': '1.26', 'groupId': 'OG006'}, {'value': '-1.0', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-0.6', 'spread': '0.20', 'groupId': 'OG008'}, {'value': '-0.3', 'spread': '0.19', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.63', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.43', 'groupId': 'OG001'}, {'value': '-1.7', 'spread': '0.56', 'groupId': 'OG002'}, {'value': '-2.7', 'spread': '0.60', 'groupId': 'OG003'}, {'value': '-0.7', 'spread': '0.41', 'groupId': 'OG004'}, {'value': '-3.7', 'spread': '1.75', 'groupId': 'OG006'}, {'value': '-0.7', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-1.1', 'spread': '0.30', 'groupId': 'OG008'}, {'value': '-0.4', 'spread': '0.29', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '1.86', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '-1.9', 'spread': '0.54', 'groupId': 'OG002'}, {'value': '-2.7', 'spread': '0.62', 'groupId': 'OG003'}, {'value': '-1.5', 'spread': '1.02', 'groupId': 'OG004'}, {'value': '-4.2', 'spread': '1.98', 'groupId': 'OG006'}, {'value': '-1.0', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-2.0', 'spread': '0.52', 'groupId': 'OG008'}, {'value': '-0.5', 'spread': '0.42', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '2.12', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': '0.65', 'groupId': 'OG002'}, {'value': '-2.7', 'spread': '0.93', 'groupId': 'OG003'}, {'value': '-2.3', 'spread': '1.67', 'groupId': 'OG004'}, {'value': '-4.4', 'spread': '1.78', 'groupId': 'OG006'}, {'value': '-2.0', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-2.8', 'spread': '0.59', 'groupId': 'OG008'}, {'value': '-0.9', 'spread': '0.64', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '2.35', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.43', 'groupId': 'OG001'}, {'value': '-2.3', 'spread': '0.68', 'groupId': 'OG002'}, {'value': '-2.8', 'spread': '0.73', 'groupId': 'OG003'}, {'value': '-2.8', 'spread': '1.75', 'groupId': 'OG004'}, {'value': '-4.4', 'spread': '1.61', 'groupId': 'OG006'}, {'value': '-1.9', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-3.5', 'spread': '0.75', 'groupId': 'OG008'}, {'value': '-1.2', 'spread': '0.91', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '2.45', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '-2.4', 'spread': '0.69', 'groupId': 'OG002'}, {'value': '-3.7', 'spread': '0.64', 'groupId': 'OG003'}, {'value': '-3.0', 'spread': '1.73', 'groupId': 'OG004'}, {'value': '-5.2', 'spread': '1.53', 'groupId': 'OG006'}, {'value': '-2.4', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-3.8', 'spread': '0.70', 'groupId': 'OG008'}, {'value': '-1.1', 'spread': '0.95', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '2.31', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.21', 'groupId': 'OG001'}, {'value': '-2.4', 'spread': '0.65', 'groupId': 'OG002'}, {'value': '-3.6', 'spread': '0.79', 'groupId': 'OG003'}, {'value': '-3.4', 'spread': '1.78', 'groupId': 'OG004'}, {'value': '-5.3', 'spread': '1.43', 'groupId': 'OG006'}, {'value': '-2.0', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-4.2', 'spread': '0.71', 'groupId': 'OG008'}, {'value': '-1.5', 'spread': '1.10', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '2.38', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.29', 'groupId': 'OG001'}, {'value': '-2.5', 'spread': '0.67', 'groupId': 'OG002'}, {'value': '-3.6', 'spread': '0.89', 'groupId': 'OG003'}, {'value': '-3.4', 'spread': '1.78', 'groupId': 'OG004'}, {'value': '-5.6', 'spread': '1.24', 'groupId': 'OG006'}, {'value': '-3.0', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-4.7', 'spread': '0.72', 'groupId': 'OG008'}, {'value': '-1.8', 'spread': '1.23', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '2.12', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.71', 'groupId': 'OG001'}, {'value': '-2.3', 'spread': '0.69', 'groupId': 'OG002'}, {'value': '-4.1', 'spread': '0.78', 'groupId': 'OG003'}, {'value': '-5.1', 'spread': '0.86', 'groupId': 'OG004'}, {'value': '-5.6', 'spread': '1.28', 'groupId': 'OG006'}, {'value': '-3.0', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-5.0', 'spread': '0.70', 'groupId': 'OG008'}, {'value': '-2.0', 'spread': '1.35', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '2.23', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '-1.9', 'spread': '0.65', 'groupId': 'OG002'}, {'value': '-4.9', 'spread': '0.71', 'groupId': 'OG003'}, {'value': '-5.1', 'spread': '0.86', 'groupId': 'OG004'}, {'value': '-5.7', 'spread': '1.21', 'groupId': 'OG006'}, {'value': '-2.6', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-5.2', 'spread': '0.74', 'groupId': 'OG008'}, {'value': '-1.9', 'spread': '1.29', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '1.93', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': '0.72', 'groupId': 'OG002'}, {'value': '-4.9', 'spread': '0.77', 'groupId': 'OG003'}, {'value': '-5.1', 'spread': '0.86', 'groupId': 'OG004'}, {'value': '-5.7', 'spread': '1.21', 'groupId': 'OG006'}, {'value': '-2.9', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-4.9', 'spread': '0.78', 'groupId': 'OG008'}, {'value': '-2.0', 'spread': '1.25', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-2.7', 'spread': '2.04', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '-1.6', 'spread': '0.80', 'groupId': 'OG002'}, {'value': '-4.4', 'spread': '0.83', 'groupId': 'OG003'}, {'value': '-5.1', 'spread': '0.86', 'groupId': 'OG004'}, {'value': '-5.7', 'spread': '1.21', 'groupId': 'OG006'}, {'value': '-2.7', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-4.8', 'spread': '0.80', 'groupId': 'OG008'}, {'value': '-2.0', 'spread': '1.24', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '2.11', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '-1.9', 'spread': '0.72', 'groupId': 'OG002'}, {'value': '-4.6', 'spread': '0.85', 'groupId': 'OG003'}, {'value': '-5.6', 'spread': '0.43', 'groupId': 'OG004'}, {'value': '-5.6', 'spread': '1.24', 'groupId': 'OG006'}, {'value': '-1.7', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-5.0', 'spread': '0.80', 'groupId': 'OG008'}, {'value': '-2.1', 'spread': '1.24', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '2.43', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': '0.62', 'groupId': 'OG002'}, {'value': '-4.3', 'spread': '0.94', 'groupId': 'OG003'}, {'value': '-5.6', 'spread': '0.36', 'groupId': 'OG004'}, {'value': '-5.5', 'spread': '1.30', 'groupId': 'OG006'}, {'value': '-1.9', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-5.0', 'spread': '0.77', 'groupId': 'OG008'}, {'value': '-5.0', 'spread': '0.81', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '2.31', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '-2.1', 'spread': '0.62', 'groupId': 'OG002'}, {'value': '-4.1', 'spread': '0.89', 'groupId': 'OG003'}, {'value': '-5.6', 'spread': '0.36', 'groupId': 'OG004'}, {'value': '-5.7', 'spread': '1.22', 'groupId': 'OG006'}, {'value': '-2.1', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-5.0', 'spread': '0.81', 'groupId': 'OG008'}, {'value': '-2.3', 'spread': '1.27', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '2.23', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '-2.5', 'spread': '0.70', 'groupId': 'OG002'}, {'value': '-3.6', 'spread': '1.01', 'groupId': 'OG003'}, {'value': '-5.6', 'spread': '0.36', 'groupId': 'OG004'}, {'value': '-5.8', 'spread': '1.19', 'groupId': 'OG006'}, {'value': '-1.4', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-4.9', 'spread': '0.80', 'groupId': 'OG008'}, {'value': '-2.2', 'spread': '1.25', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-3.5', 'spread': '2.03', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '-2.3', 'spread': '0.66', 'groupId': 'OG002'}, {'value': '-3.7', 'spread': '0.98', 'groupId': 'OG003'}, {'value': '-5.6', 'spread': '0.36', 'groupId': 'OG004'}, {'value': '-5.7', 'spread': '1.21', 'groupId': 'OG006'}, {'value': '-1.4', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-4.6', 'spread': '0.95', 'groupId': 'OG008'}, {'value': '-2.5', 'spread': '1.29', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '2.12', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '-2.3', 'spread': '0.74', 'groupId': 'OG002'}, {'value': '-3.6', 'spread': '1.00', 'groupId': 'OG003'}, {'value': '-5.7', 'spread': '0.43', 'groupId': 'OG004'}, {'value': '-5.7', 'spread': '1.21', 'groupId': 'OG006'}, {'value': '-1.3', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-4.6', 'spread': '0.96', 'groupId': 'OG008'}, {'value': '-2.5', 'spread': '1.29', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 1-18', 'description': 'Participants were asked daily to assign a numerical score to the quality of their sleep in the previous night using a scale from 0 to 10, with 0 indicating best possible sleep and 10 indicating worst possible sleep.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'KPL-716: CIU Cohort', 'description': 'Participants with CIU received KPL-716 weekly for 8 weeks'}, {'id': 'OG001', 'title': 'Placebo: CIU Cohort', 'description': 'Participants with CIU received placebo weekly for 8 weeks'}, {'id': 'OG002', 'title': 'KPL-716: CIP Cohort', 'description': 'Participants with CIP received KPL-716 weekly for 8 weeks'}, {'id': 'OG003', 'title': 'Placebo: CIP Cohort', 'description': 'Participants with CIP received placebo weekly for 8 weeks'}, {'id': 'OG004', 'title': 'KPL-716: LP Cohort', 'description': 'Participants with LP received KPL-716 weekly for 8 weeks'}, {'id': 'OG005', 'title': 'Placebo: LP Cohort', 'description': 'Participants with LP received placebo weekly for 8 weeks'}, {'id': 'OG006', 'title': 'KPL-716: LSC Cohort', 'description': 'Participants with LSC received KPL-716 weekly for 8 weeks'}, {'id': 'OG007', 'title': 'Placebo: LSC Cohort', 'description': 'Participants with LSC received placebo weekly for 8 weeks'}, {'id': 'OG008', 'title': 'KPL-716: PPs Cohort', 'description': 'Participants with PPs received KPL-716 weekly for 8 weeks'}, {'id': 'OG009', 'title': 'Placebo: PPs Cohort', 'description': 'Participants with PPs received placebo weekly for 8 weeks'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '32.15', 'groupId': 'OG000'}, {'value': '-28.7', 'spread': '45.50', 'groupId': 'OG001'}, {'value': '-2.6', 'spread': '5.75', 'groupId': 'OG002'}, {'value': '-26.3', 'spread': '7.18', 'groupId': 'OG003'}, {'value': '-3.0', 'spread': '2.92', 'groupId': 'OG004'}, {'value': '-40.7', 'spread': '17.63', 'groupId': 'OG006'}, {'value': '-1.4', 'spread': '38.74', 'groupId': 'OG007'}, {'value': '-6.7', 'spread': '2.75', 'groupId': 'OG008'}, {'value': '-4.9', 'spread': '3.91', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-20.2', 'spread': '34.79', 'groupId': 'OG000'}, {'value': '-42.6', 'spread': '49.24', 'groupId': 'OG001'}, {'value': '-28.7', 'spread': '8.26', 'groupId': 'OG002'}, {'value': '-45.6', 'spread': '10.32', 'groupId': 'OG003'}, {'value': '-9.2', 'spread': '7.29', 'groupId': 'OG004'}, {'value': '-56.7', 'spread': '24.07', 'groupId': 'OG006'}, {'value': '6.8', 'spread': '52.89', 'groupId': 'OG007'}, {'value': '-12.4', 'spread': '3.67', 'groupId': 'OG008'}, {'value': '-6.0', 'spread': '5.22', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-15.5', 'spread': '39.26', 'groupId': 'OG000'}, {'value': '-49.7', 'spread': '55.57', 'groupId': 'OG001'}, {'value': '-33.4', 'spread': '7.94', 'groupId': 'OG002'}, {'value': '-47.2', 'spread': '9.92', 'groupId': 'OG003'}, {'value': '-18.9', 'spread': '17.50', 'groupId': 'OG004'}, {'value': '-64.4', 'spread': '26.92', 'groupId': 'OG006'}, {'value': '6.3', 'spread': '59.14', 'groupId': 'OG007'}, {'value': '-22.7', 'spread': '6.03', 'groupId': 'OG008'}, {'value': '-7.1', 'spread': '8.58', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-25.0', 'spread': '31.15', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '44.09', 'groupId': 'OG001'}, {'value': '-34.6', 'spread': '10.18', 'groupId': 'OG002'}, {'value': '-47.9', 'spread': '12.72', 'groupId': 'OG003'}, {'value': '-29.8', 'spread': '28.43', 'groupId': 'OG004'}, {'value': '-67.2', 'spread': '22.95', 'groupId': 'OG006'}, {'value': '-6.6', 'spread': '50.42', 'groupId': 'OG007'}, {'value': '-34.4', 'spread': '6.75', 'groupId': 'OG008'}, {'value': '-11.7', 'spread': '9.60', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-25.7', 'spread': '42.76', 'groupId': 'OG000'}, {'value': '-43.4', 'spread': '60.51', 'groupId': 'OG001'}, {'value': '-38.4', 'spread': '9.11', 'groupId': 'OG002'}, {'value': '-50.7', 'spread': '11.38', 'groupId': 'OG003'}, {'value': '-35.5', 'spread': '30.62', 'groupId': 'OG004'}, {'value': '-67.3', 'spread': '23.31', 'groupId': 'OG006'}, {'value': '-16.9', 'spread': '51.21', 'groupId': 'OG007'}, {'value': '-43.0', 'spread': '7.95', 'groupId': 'OG008'}, {'value': '-15.9', 'spread': '11.31', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-20.9', 'spread': '47.36', 'groupId': 'OG000'}, {'value': '-50.4', 'spread': '67.03', 'groupId': 'OG001'}, {'value': '-40.9', 'spread': '8.43', 'groupId': 'OG002'}, {'value': '-62.7', 'spread': '10.54', 'groupId': 'OG003'}, {'value': '-38.1', 'spread': '30.62', 'groupId': 'OG004'}, {'value': '-80.2', 'spread': '22.99', 'groupId': 'OG006'}, {'value': '-32.7', 'spread': '50.51', 'groupId': 'OG007'}, {'value': '-46.7', 'spread': '7.82', 'groupId': 'OG008'}, {'value': '-13.0', 'spread': '11.12', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-23.2', 'spread': '37.03', 'groupId': 'OG000'}, {'value': '-22.9', 'spread': '52.41', 'groupId': 'OG001'}, {'value': '-42.4', 'spread': '8.45', 'groupId': 'OG002'}, {'value': '-61.6', 'spread': '10.55', 'groupId': 'OG003'}, {'value': '-44.6', 'spread': '30.62', 'groupId': 'OG004'}, {'value': '-82.4', 'spread': '20.44', 'groupId': 'OG006'}, {'value': '-27.3', 'spread': '44.90', 'groupId': 'OG007'}, {'value': '-52.0', 'spread': '8.41', 'groupId': 'OG008'}, {'value': '-19.4', 'spread': '11.96', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-19.5', 'spread': '40.74', 'groupId': 'OG000'}, {'value': '-29.9', 'spread': '57.65', 'groupId': 'OG001'}, {'value': '-43.4', 'spread': '8.98', 'groupId': 'OG002'}, {'value': '-60.7', 'spread': '11.22', 'groupId': 'OG003'}, {'value': '-44.6', 'spread': '30.62', 'groupId': 'OG004'}, {'value': '-87.3', 'spread': '14.69', 'groupId': 'OG006'}, {'value': '-37.0', 'spread': '32.27', 'groupId': 'OG007'}, {'value': '-59.5', 'spread': '8.96', 'groupId': 'OG008'}, {'value': '-23.1', 'spread': '12.75', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-28.7', 'spread': '15.95', 'groupId': 'OG000'}, {'value': '66.0', 'spread': '22.57', 'groupId': 'OG001'}, {'value': '-42.2', 'spread': '8.76', 'groupId': 'OG002'}, {'value': '-66.6', 'spread': '10.13', 'groupId': 'OG003'}, {'value': '-66.9', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-86.2', 'spread': '15.97', 'groupId': 'OG006'}, {'value': '-37.3', 'spread': '35.08', 'groupId': 'OG007'}, {'value': '-63.6', 'spread': '9.13', 'groupId': 'OG008'}, {'value': '-25.5', 'spread': '12.99', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-21.5', 'spread': '41.87', 'groupId': 'OG000'}, {'value': '-50.1', 'spread': '59.26', 'groupId': 'OG001'}, {'value': '-37.4', 'spread': '8.65', 'groupId': 'OG002'}, {'value': '-76.4', 'spread': '10.00', 'groupId': 'OG003'}, {'value': '-66.9', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-88.4', 'spread': '13.41', 'groupId': 'OG006'}, {'value': '-31.9', 'spread': '29.47', 'groupId': 'OG007'}, {'value': '-65.9', 'spread': '9.22', 'groupId': 'OG008'}, {'value': '-25.1', 'spread': '13.11', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-29.0', 'spread': '31.17', 'groupId': 'OG000'}, {'value': '-49.4', 'spread': '44.11', 'groupId': 'OG001'}, {'value': '-37.1', 'spread': '9.54', 'groupId': 'OG002'}, {'value': '-76.5', 'spread': '11.03', 'groupId': 'OG003'}, {'value': '-66.9', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-88.4', 'spread': '13.41', 'groupId': 'OG006'}, {'value': '-35.1', 'spread': '29.47', 'groupId': 'OG007'}, {'value': '-61.1', 'spread': '9.12', 'groupId': 'OG008'}, {'value': '-26.1', 'spread': '12.97', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-29.3', 'spread': '34.97', 'groupId': 'OG000'}, {'value': '-49.7', 'spread': '49.49', 'groupId': 'OG001'}, {'value': '-30.9', 'spread': '11.35', 'groupId': 'OG002'}, {'value': '-70.1', 'spread': '13.12', 'groupId': 'OG003'}, {'value': '-66.9', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-88.4', 'spread': '13.41', 'groupId': 'OG006'}, {'value': '-33.5', 'spread': '29.47', 'groupId': 'OG007'}, {'value': '-60.2', 'spread': '9.58', 'groupId': 'OG008'}, {'value': '-27.0', 'spread': '13.63', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-24.0', 'spread': '35.58', 'groupId': 'OG000'}, {'value': '-49.7', 'spread': '50.36', 'groupId': 'OG001'}, {'value': '-35.9', 'spread': '10.59', 'groupId': 'OG002'}, {'value': '-74.7', 'spread': '12.24', 'groupId': 'OG003'}, {'value': '-72.8', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-87.3', 'spread': '14.69', 'groupId': 'OG006'}, {'value': '-22.7', 'spread': '32.27', 'groupId': 'OG007'}, {'value': '-63.9', 'spread': '9.92', 'groupId': 'OG008'}, {'value': '-28.4', 'spread': '14.11', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-20.4', 'spread': '42.00', 'groupId': 'OG000'}, {'value': '-50.3', 'spread': '59.44', 'groupId': 'OG001'}, {'value': '-38.2', 'spread': '9.62', 'groupId': 'OG002'}, {'value': '-71.9', 'spread': '11.12', 'groupId': 'OG003'}, {'value': '-73.8', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-85.7', 'spread': '16.60', 'groupId': 'OG006'}, {'value': '-24.8', 'spread': '36.48', 'groupId': 'OG007'}, {'value': '-64.9', 'spread': '9.77', 'groupId': 'OG008'}, {'value': '-29.3', 'spread': '13.90', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-25.9', 'spread': '37.20', 'groupId': 'OG000'}, {'value': '-49.9', 'spread': '52.64', 'groupId': 'OG001'}, {'value': '-38.6', 'spread': '9.08', 'groupId': 'OG002'}, {'value': '-69.7', 'spread': '10.50', 'groupId': 'OG003'}, {'value': '-73.8', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-87.9', 'spread': '14.05', 'groupId': 'OG006'}, {'value': '-27.3', 'spread': '30.87', 'groupId': 'OG007'}, {'value': '-63.9', 'spread': '10.34', 'groupId': 'OG008'}, {'value': '-31.3', 'spread': '14.70', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-33.5', 'spread': '35.42', 'groupId': 'OG000'}, {'value': '-49.7', 'spread': '50.13', 'groupId': 'OG001'}, {'value': '-44.1', 'spread': '10.40', 'groupId': 'OG002'}, {'value': '-64.0', 'spread': '12.02', 'groupId': 'OG003'}, {'value': '-73.8', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-89.0', 'spread': '12.77', 'groupId': 'OG006'}, {'value': '-19.1', 'spread': '28.06', 'groupId': 'OG007'}, {'value': '-63.6', 'spread': '10.16', 'groupId': 'OG008'}, {'value': '-29.4', 'spread': '14.45', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-48.6', 'spread': '28.92', 'groupId': 'OG000'}, {'value': '-49.0', 'spread': '40.94', 'groupId': 'OG001'}, {'value': '-41.3', 'spread': '9.88', 'groupId': 'OG002'}, {'value': '-65.1', 'spread': '11.42', 'groupId': 'OG003'}, {'value': '-73.8', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-88.4', 'spread': '13.41', 'groupId': 'OG006'}, {'value': '-19.2', 'spread': '29.47', 'groupId': 'OG007'}, {'value': '-58.7', 'spread': '12.22', 'groupId': 'OG008'}, {'value': '-34.8', 'spread': '17.38', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-41.8', 'spread': '31.93', 'groupId': 'OG000'}, {'value': '-49.4', 'spread': '45.20', 'groupId': 'OG001'}, {'value': '-42.8', 'spread': '10.42', 'groupId': 'OG002'}, {'value': '-64.7', 'spread': '12.04', 'groupId': 'OG003'}, {'value': '-74.7', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-88.4', 'spread': '13.41', 'groupId': 'OG006'}, {'value': '-17.6', 'spread': '29.47', 'groupId': 'OG007'}, {'value': '-58.7', 'spread': '12.25', 'groupId': 'OG008'}, {'value': '-34.7', 'spread': '17.43', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '0.6532', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '27.7', 'ciLowerLimit': '-63.60', 'ciUpperLimit': '119.06', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '55.77', 'groupDescription': 'Change at Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0187', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '23.6', 'ciLowerLimit': '11.38', 'ciUpperLimit': '35.85', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.23', 'groupDescription': 'Change at Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4707', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-39.3', 'ciLowerLimit': '-123.27', 'ciUpperLimit': '44.68', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '44.53', 'groupDescription': 'Change at Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7108', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-1.8', 'ciLowerLimit': '-8.22', 'ciUpperLimit': '4.59', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.81', 'groupDescription': 'Change at Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7355', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '22.4', 'ciLowerLimit': '-76.47', 'ciUpperLimit': '121.23', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '60.36', 'groupDescription': 'Change at Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2167', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '16.9', 'ciLowerLimit': '-0.66', 'ciUpperLimit': '34.52', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.27', 'groupDescription': 'Change at Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4058', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-63.5', 'ciLowerLimit': '-178.16', 'ciUpperLimit': '51.13', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '60.80', 'groupDescription': 'Change at Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3323', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-6.4', 'ciLowerLimit': '-14.95', 'ciUpperLimit': '2.15', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.43', 'groupDescription': 'Change at Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6496', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '34.3', 'ciLowerLimit': '-77.29', 'ciUpperLimit': '145.80', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '68.11', 'groupDescription': 'Change at Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2925', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '13.8', 'ciLowerLimit': '-3.12', 'ciUpperLimit': '30.70', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.76', 'groupDescription': 'Change at Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4074', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-70.7', 'ciLowerLimit': '-198.92', 'ciUpperLimit': '57.46', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '67.98', 'groupDescription': 'Change at Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1584', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-15.5', 'ciLowerLimit': '-29.60', 'ciUpperLimit': '-1.49', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.56', 'groupDescription': 'Change at Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.7013', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-22.8', 'ciLowerLimit': '-111.31', 'ciUpperLimit': '65.69', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '54.04', 'groupDescription': 'Change at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4230', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '13.4', 'ciLowerLimit': '-8.30', 'ciUpperLimit': '35.05', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '16.35', 'groupDescription': 'Change at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4055', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-60.6', 'ciLowerLimit': '-169.90', 'ciUpperLimit': '48.69', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '57.96', 'groupDescription': 'Change at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0709', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-22.7', 'ciLowerLimit': '-38.41', 'ciUpperLimit': '-6.96', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.82', 'groupDescription': 'Change at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8268', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '17.7', 'ciLowerLimit': '-103.77', 'ciUpperLimit': '139.17', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '74.17', 'groupDescription': 'Change at Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4082', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '12.4', 'ciLowerLimit': '-7.03', 'ciUpperLimit': '31.75', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '14.63', 'groupDescription': 'Change at Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4818', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-50.4', 'ciLowerLimit': '-161.43', 'ciUpperLimit': '60.56', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '58.86', 'groupDescription': 'Change at Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0673', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-27.1', 'ciLowerLimit': '-45.64', 'ciUpperLimit': '-8.58', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.93', 'groupDescription': 'Change at Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7429', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '29.6', 'ciLowerLimit': '-105.00', 'ciUpperLimit': '164.10', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '82.15', 'groupDescription': 'Change at Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1227', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '21.8', 'ciLowerLimit': '3.88', 'ciUpperLimit': '39.79', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.55', 'groupDescription': 'Change at Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4996', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-47.5', 'ciLowerLimit': '-156.95', 'ciUpperLimit': '62.02', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '58.06', 'groupDescription': 'Change at Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0244', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-33.6', 'ciLowerLimit': '-51.87', 'ciUpperLimit': '-15.43', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.69', 'groupDescription': 'Change at Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9967', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.3', 'ciLowerLimit': '-105.50', 'ciUpperLimit': '104.92', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '64.24', 'groupDescription': 'Change at Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1739', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '19.1', 'ciLowerLimit': '1.15', 'ciUpperLimit': '37.12', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.57', 'groupDescription': 'Change at Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3978', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-55.1', 'ciLowerLimit': '-152.39', 'ciUpperLimit': '42.26', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '51.61', 'groupDescription': 'Change at Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0397', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-32.7', 'ciLowerLimit': '-52.26', 'ciUpperLimit': '-13.07', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '14.73', 'groupDescription': 'Change at Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8922', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '10.4', 'ciLowerLimit': '-105.32', 'ciUpperLimit': '126.14', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '70.66', 'groupDescription': 'Change at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2439', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '17.3', 'ciLowerLimit': '-1.80', 'ciUpperLimit': '36.45', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '14.43', 'groupDescription': 'Change at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3076', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-50.3', 'ciLowerLimit': '-120.29', 'ciUpperLimit': '19.61', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '37.10', 'groupDescription': 'Change at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0322', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-36.4', 'ciLowerLimit': '-57.32', 'ciUpperLimit': '-15.55', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '15.70', 'groupDescription': 'Change at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0418', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-94.7', 'ciLowerLimit': '-139.98', 'ciUpperLimit': '-49.36', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '27.67', 'groupDescription': 'Change at Week 9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0865', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '24.4', 'ciLowerLimit': '6.49', 'ciUpperLimit': '42.26', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.44', 'groupDescription': 'Change at Week 9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3489', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-48.9', 'ciLowerLimit': '-124.96', 'ciUpperLimit': '27.11', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '40.32', 'groupDescription': 'Change at Week 9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0286', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-38.1', 'ciLowerLimit': '-59.34', 'ciUpperLimit': '-16.79', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '15.99', 'groupDescription': 'Change at Week 9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7198', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '28.6', 'ciLowerLimit': '-90.32', 'ciUpperLimit': '147.59', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '72.63', 'groupDescription': 'Change at Week 10', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0088', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '39.0', 'ciLowerLimit': '21.32', 'ciUpperLimit': '56.63', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.27', 'groupDescription': 'Change at Week 10', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2371', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-56.5', 'ciLowerLimit': '-120.39', 'ciUpperLimit': '7.34', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '33.87', 'groupDescription': 'Change at Week 10', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0210', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-40.8', 'ciLowerLimit': '-62.30', 'ciUpperLimit': '-19.35', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '16.14', 'groupDescription': 'Change at Week 10', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7312', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '20.4', 'ciLowerLimit': '-68.17', 'ciUpperLimit': '108.94', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '54.07', 'groupDescription': 'Change at Week 11', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0150', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '39.4', 'ciLowerLimit': '19.88', 'ciUpperLimit': '58.83', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '14.64', 'groupDescription': 'Change at Week 11', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2559', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-53.3', 'ciLowerLimit': '-117.22', 'ciUpperLimit': '10.52', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '33.87', 'groupDescription': 'Change at Week 11', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0419', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-35.0', 'ciLowerLimit': '-56.21', 'ciUpperLimit': '-13.72', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '15.97', 'groupDescription': 'Change at Week 11', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7589', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '20.4', 'ciLowerLimit': '-78.95', 'ciUpperLimit': '119.74', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '60.66', 'groupDescription': 'Change at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0374', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '39.1', 'ciLowerLimit': '15.97', 'ciUpperLimit': '62.31', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '17.42', 'groupDescription': 'Change at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2463', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-54.9', 'ciLowerLimit': '-118.80', 'ciUpperLimit': '8.93', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '33.87', 'groupDescription': 'Change at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0632', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-33.2', 'ciLowerLimit': '-55.56', 'ciUpperLimit': '-10.90', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '16.78', 'groupDescription': 'Change at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7053', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '25.7', 'ciLowerLimit': '-75.41', 'ciUpperLimit': '126.78', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '61.73', 'groupDescription': 'Change at Week 13', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0285', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '38.7', 'ciLowerLimit': '17.09', 'ciUpperLimit': '60.34', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '16.25', 'groupDescription': 'Change at Week 13', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2236', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-64.6', 'ciLowerLimit': '-134.58', 'ciUpperLimit': '5.32', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '37.10', 'groupDescription': 'Change at Week 13', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0558', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-35.5', 'ciLowerLimit': '-58.65', 'ciUpperLimit': '-12.41', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '17.38', 'groupDescription': 'Change at Week 13', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.7089', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '29.9', 'ciLowerLimit': '-89.41', 'ciUpperLimit': '149.24', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '72.86', 'groupDescription': 'Change at Week 14', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0347', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '33.7', 'ciLowerLimit': '14.08', 'ciUpperLimit': '53.35', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '14.76', 'groupDescription': 'Change at Week 14', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2835', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-60.9', 'ciLowerLimit': '-139.99', 'ciUpperLimit': '18.16', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '41.94', 'groupDescription': 'Change at Week 14', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0525', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-35.5', 'ciLowerLimit': '-58.31', 'ciUpperLimit': '-12.77', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '17.11', 'groupDescription': 'Change at Week 14', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7347', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '24.0', 'ciLowerLimit': '-81.68', 'ciUpperLimit': '129.66', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '64.52', 'groupDescription': 'Change at Week 15', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0390', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '31.0', 'ciLowerLimit': '12.50', 'ciUpperLimit': '49.60', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.94', 'groupDescription': 'Change at Week 15', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2299', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-60.6', 'ciLowerLimit': '-127.49', 'ciUpperLimit': '6.33', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '35.48', 'groupDescription': 'Change at Week 15', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0884', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-32.6', 'ciLowerLimit': '-56.70', 'ciUpperLimit': '-8.53', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '18.11', 'groupDescription': 'Change at Week 15', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8085', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '16.3', 'ciLowerLimit': '-84.37', 'ciUpperLimit': '116.87', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '61.44', 'groupDescription': 'Change at Week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2283', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '19.9', 'ciLowerLimit': '-1.33', 'ciUpperLimit': '41.14', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '15.96', 'groupDescription': 'Change at Week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1625', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-69.9', 'ciLowerLimit': '-130.76', 'ciUpperLimit': '-9.11', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '32.26', 'groupDescription': 'Change at Week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0707', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-34.2', 'ciLowerLimit': '-57.87', 'ciUpperLimit': '-10.52', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '17.80', 'groupDescription': 'Change at Week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9944', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.4', 'ciLowerLimit': '-81.79', 'ciUpperLimit': '82.55', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '50.17', 'groupDescription': 'Change at Week 17', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1327', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '23.9', 'ciLowerLimit': '3.71', 'ciUpperLimit': '44.05', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '15.16', 'groupDescription': 'Change at Week 17', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1777', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-69.2', 'ciLowerLimit': '-133.09', 'ciUpperLimit': '-5.35', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '33.87', 'groupDescription': 'Change at Week 17', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2796', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-23.9', 'ciLowerLimit': '-52.34', 'ciUpperLimit': '4.61', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '21.40', 'groupDescription': 'Change at Week 17', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8999', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '7.6', 'ciLowerLimit': '-83.15', 'ciUpperLimit': '98.30', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '55.40', 'groupDescription': 'Change at Week 18', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1867', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '22.0', 'ciLowerLimit': '0.68', 'ciUpperLimit': '43.23', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '15.99', 'groupDescription': 'Change at Week 18', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1717', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-70.8', 'ciLowerLimit': '-134.68', 'ciUpperLimit': '-6.94', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '33.87', 'groupDescription': 'Change at Week 18', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2792', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-23.9', 'ciLowerLimit': '-52.50', 'ciUpperLimit': '4.61', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '21.46', 'groupDescription': 'Change at Week 18', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 1-18', 'description': 'Participants were asked daily to assign a numerical score to the quality of their sleep in the previous night using a scale from 0 to 10, with 0 indicating best possible sleep and 10 indicating worst possible sleep.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'KPL-716: CIU Cohort', 'description': 'Participants with CIU received KPL-716 weekly for 8 weeks'}, {'id': 'OG001', 'title': 'Placebo: CIU Cohort', 'description': 'Participants with CIU received placebo weekly for 8 weeks'}, {'id': 'OG002', 'title': 'KPL-716: CIP Cohort', 'description': 'Participants with CIP received KPL-716 weekly for 8 weeks'}, {'id': 'OG003', 'title': 'Placebo: CIP Cohort', 'description': 'Participants with CIP received placebo weekly for 8 weeks'}, {'id': 'OG004', 'title': 'KPL-716: LP Cohort', 'description': 'Participants with LP received KPL-716 weekly for 8 weeks'}, {'id': 'OG005', 'title': 'Placebo: LP Cohort', 'description': 'Participants with LP received placebo weekly for 8 weeks'}, {'id': 'OG006', 'title': 'KPL-716: LSC Cohort', 'description': 'Participants with LSC received KPL-716 weekly for 8 weeks'}, {'id': 'OG007', 'title': 'Placebo: LSC Cohort', 'description': 'Participants with LSC received placebo weekly for 8 weeks'}, {'id': 'OG008', 'title': 'KPL-716: PPs Cohort', 'description': 'Participants with PPs received KPL-716 weekly for 8 weeks'}, {'id': 'OG009', 'title': 'Placebo: PPs Cohort', 'description': 'Participants with PPs received placebo weekly for 8 weeks'}], 'classes': [{'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-5.8', 'spread': '1.49', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '-3.4', 'spread': '0.86', 'groupId': 'OG002'}, {'value': '-8.0', 'spread': '1.96', 'groupId': 'OG003'}, {'value': '-4.7', 'spread': '2.60', 'groupId': 'OG004'}, {'value': '-4.5', 'spread': '2.99', 'groupId': 'OG006'}, {'value': '0.0', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-10.0', 'spread': '1.83', 'groupId': 'OG008'}, {'value': '-0.6', 'spread': '3.12', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-6.5', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '-3.6', 'spread': '1.37', 'groupId': 'OG002'}, {'value': '-8.3', 'spread': '2.01', 'groupId': 'OG003'}, {'value': '-4.7', 'spread': '2.60', 'groupId': 'OG004'}, {'value': '-3.0', 'spread': '4.55', 'groupId': 'OG006'}, {'value': '-12.0', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-11.2', 'spread': '1.75', 'groupId': 'OG008'}, {'value': '-1.4', 'spread': '3.33', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-6.5', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '-4.3', 'spread': '1.53', 'groupId': 'OG002'}, {'value': '-8.3', 'spread': '2.01', 'groupId': 'OG003'}, {'value': '-7.0', 'spread': '2.00', 'groupId': 'OG004'}, {'value': '-3.0', 'spread': '4.55', 'groupId': 'OG006'}, {'value': '-12.0', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-10.7', 'spread': '1.69', 'groupId': 'OG008'}, {'value': '-1.5', 'spread': '3.76', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-7.3', 'spread': '1.55', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '-4.8', 'spread': '1.83', 'groupId': 'OG002'}, {'value': '-7.9', 'spread': '2.25', 'groupId': 'OG003'}, {'value': '-10.0', 'spread': '1.00', 'groupId': 'OG004'}, {'value': '-6.3', 'spread': '2.29', 'groupId': 'OG006'}, {'value': '-5.0', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-10.0', 'spread': '1.82', 'groupId': 'OG008'}, {'value': '-9.5', 'spread': '2.46', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-6.0', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '-4.4', 'spread': '2.02', 'groupId': 'OG002'}, {'value': '-8.7', 'spread': '2.28', 'groupId': 'OG003'}, {'value': '-17.5', 'spread': '5.50', 'groupId': 'OG004'}, {'value': '-6.5', 'spread': '2.18', 'groupId': 'OG006'}, {'value': '-8.0', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-9.9', 'spread': '2.01', 'groupId': 'OG008'}, {'value': '-9.2', 'spread': '2.04', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 18', 'description': 'The DLQI is a 10-question questionnaire that considers symptoms and feelings, daily activities, leisure, school, personal relationships, and treatment. Each question, except question 7, is answered on a scale of 0 to 3 (0 for not at all, 1 for a little, 2 for a lot, and 3 for very much), taking into account the previous week. For question 7: participants were asked "Over the last week, has your skin prevented you from working or studying?" If answered yes, score=3; If no, a second question will be asked: "Over the last week how much has your skin been a problem at work or studying?" If further answered a lot, score=2; if a little, score=1; if not at all or not relevant, score=0. The DLQI total score is defined as the sum of all 10-question scores with minimum of 0 meaning no effect on quality of life and 30 meaning extremely large effect.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in DLQI Total Score Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'KPL-716: CIU Cohort', 'description': 'Participants with CIU received KPL-716 weekly for 8 weeks'}, {'id': 'OG001', 'title': 'Placebo: CIU Cohort', 'description': 'Participants with CIU received placebo weekly for 8 weeks'}, {'id': 'OG002', 'title': 'KPL-716: CIP Cohort', 'description': 'Participants with CIP received KPL-716 weekly for 8 weeks'}, {'id': 'OG003', 'title': 'Placebo: CIP Cohort', 'description': 'Participants with CIP received placebo weekly for 8 weeks'}, {'id': 'OG004', 'title': 'KPL-716: LP Cohort', 'description': 'Participants with LP received KPL-716 weekly for 8 weeks'}, {'id': 'OG005', 'title': 'Placebo: LP Cohort', 'description': 'Participants with LP received placebo weekly for 8 weeks'}, {'id': 'OG006', 'title': 'KPL-716: LSC Cohort', 'description': 'Participants with LSC received KPL-716 weekly for 8 weeks'}, {'id': 'OG007', 'title': 'Placebo: LSC Cohort', 'description': 'Participants with LSC received placebo weekly for 8 weeks'}, {'id': 'OG008', 'title': 'KPL-716: PPs Cohort', 'description': 'Participants with PPs received KPL-716 weekly for 8 weeks'}, {'id': 'OG009', 'title': 'Placebo: PPs Cohort', 'description': 'Participants with PPs received placebo weekly for 8 weeks'}], 'classes': [{'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-51.0', 'spread': '17.71', 'groupId': 'OG000'}, {'value': '-3.7', 'spread': '25.35', 'groupId': 'OG001'}, {'value': '-32.8', 'spread': '8.77', 'groupId': 'OG002'}, {'value': '-52.4', 'spread': '10.95', 'groupId': 'OG003'}, {'value': '-24.2', 'spread': '17.01', 'groupId': 'OG004'}, {'value': '-53.5', 'spread': '33.55', 'groupId': 'OG006'}, {'value': '6.1', 'spread': '94.72', 'groupId': 'OG007'}, {'value': '-68.2', 'spread': '11.77', 'groupId': 'OG008'}, {'value': '4.1', 'spread': '16.65', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-54.5', 'spread': '12.95', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '18.53', 'groupId': 'OG001'}, {'value': '-41.1', 'spread': '13.32', 'groupId': 'OG002'}, {'value': '-56.0', 'spread': '16.63', 'groupId': 'OG003'}, {'value': '-24.2', 'spread': '17.01', 'groupId': 'OG004'}, {'value': '-32.5', 'spread': '64.55', 'groupId': 'OG006'}, {'value': '-85.7', 'spread': '182.21', 'groupId': 'OG007'}, {'value': '-72.2', 'spread': '10.71', 'groupId': 'OG008'}, {'value': '-2.3', 'spread': '15.15', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-54.5', 'spread': '12.95', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '18.53', 'groupId': 'OG001'}, {'value': '-48.1', 'spread': '14.36', 'groupId': 'OG002'}, {'value': '-55.7', 'spread': '16.59', 'groupId': 'OG003'}, {'value': '-36.4', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-32.5', 'spread': '64.55', 'groupId': 'OG006'}, {'value': '-85.7', 'spread': '182.21', 'groupId': 'OG007'}, {'value': '-72.9', 'spread': '11.58', 'groupId': 'OG008'}, {'value': '-5.4', 'spread': '17.75', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-60.5', 'spread': '15.08', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '21.57', 'groupId': 'OG001'}, {'value': '-51.0', 'spread': '11.94', 'groupId': 'OG002'}, {'value': '-54.0', 'spread': '13.79', 'groupId': 'OG003'}, {'value': '-61.4', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-71.9', 'spread': '23.07', 'groupId': 'OG006'}, {'value': '-41.5', 'spread': '65.13', 'groupId': 'OG007'}, {'value': '-69.6', 'spread': '8.18', 'groupId': 'OG008'}, {'value': '-60.7', 'spread': '12.54', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-52.5', 'spread': '18.16', 'groupId': 'OG000'}, {'value': '-3.4', 'spread': '25.99', 'groupId': 'OG001'}, {'value': '-44.0', 'spread': '12.37', 'groupId': 'OG002'}, {'value': '-61.3', 'spread': '14.29', 'groupId': 'OG003'}, {'value': '-89.7', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-75.0', 'spread': '19.53', 'groupId': 'OG006'}, {'value': '-52.4', 'spread': '55.14', 'groupId': 'OG007'}, {'value': '-68.7', 'spread': '9.18', 'groupId': 'OG008'}, {'value': '-62.6', 'spread': '14.08', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '0.2289', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-47.3', 'ciLowerLimit': '-98.77', 'ciUpperLimit': '4.10', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '31.41', 'groupDescription': 'Change at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1788', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '19.6', 'ciLowerLimit': '0.96', 'ciUpperLimit': '38.27', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '14.08', 'groupDescription': 'Change at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6544', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-59.6', 'ciLowerLimit': '-275.19', 'ciUpperLimit': '156.06', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '114.35', 'groupDescription': 'Change at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0023', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-72.2', 'ciLowerLimit': '-99.39', 'ciUpperLimit': '-45.09', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '20.40', 'groupDescription': 'Change at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1081', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-52.1', 'ciLowerLimit': '-89.68', 'ciUpperLimit': '-14.47', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '22.96', 'groupDescription': 'Change at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4926', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '14.9', 'ciLowerLimit': '-13.39', 'ciUpperLimit': '43.26', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '21.37', 'groupDescription': 'Change at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8315', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '53.2', 'ciLowerLimit': '-361.63', 'ciUpperLimit': '467.98', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '219.98', 'groupDescription': 'Change at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0014', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-69.9', 'ciLowerLimit': '-94.61', 'ciUpperLimit': '-45.22', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '18.56', 'groupDescription': 'Change at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1081', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-52.1', 'ciLowerLimit': '-89.68', 'ciUpperLimit': '-14.47', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '22.96', 'groupDescription': 'Change at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7339', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '7.6', 'ciLowerLimit': '-21.65', 'ciUpperLimit': '36.82', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '21.97', 'groupDescription': 'Change at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8315', 'groupIds': ['OG007', 'OG008'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '53.2', 'ciLowerLimit': '-361.63', 'ciUpperLimit': '467.98', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '219.98', 'groupDescription': 'Change at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0055', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-67.6', 'ciLowerLimit': '-95.92', 'ciUpperLimit': '-39.22', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '21.26', 'groupDescription': 'Change at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1188', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-57.9', 'ciLowerLimit': '-101.70', 'ciUpperLimit': '-14.15', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '26.73', 'groupDescription': 'Change at Week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8697', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '3.0', 'ciLowerLimit': '-21.26', 'ciUpperLimit': '27.35', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '18.27', 'groupDescription': 'Change at Week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7368', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-30.3', 'ciLowerLimit': '-178.62', 'ciUpperLimit': '117.94', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '78.64', 'groupDescription': 'Change at Week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5571', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-9.0', 'ciLowerLimit': '-29.03', 'ciUpperLimit': '11.03', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '15.02', 'groupDescription': 'Change at Week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2251', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-49.1', 'ciLowerLimit': '-101.80', 'ciUpperLimit': '3.69', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '32.21', 'groupDescription': 'Change at Week 18', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3733', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '17.3', 'ciLowerLimit': '-7.90', 'ciUpperLimit': '42.48', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '18.93', 'groupDescription': 'Change at Week 18', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7662', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-22.6', 'ciLowerLimit': '-148.16', 'ciUpperLimit': '102.89', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '66.57', 'groupDescription': 'Change at Week 18', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7241', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-6.1', 'ciLowerLimit': '-28.54', 'ciUpperLimit': '16.44', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '16.87', 'groupDescription': 'Change at Week 18', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 18', 'description': 'The DLQI is a 10-question questionnaire that considers symptoms and feelings, daily activities, leisure, school, personal relationships, and treatment. Each question, except question 7, is answered on a scale of 0 to 3 (0 for not at all, 1 for a little, 2 for a lot, and 3 for very much), taking into account the previous week. For question 7: participants were asked "Over the last week, has your skin prevented you from working or studying?" If answered yes, score=3; If no, a second question will be asked: "Over the last week how much has your skin been a problem at work or studying?" If further answered a lot, score=2; if a little, score=1; if not at all or not relevant, score=0. The DLQI total score is defined as the sum of all 10-question scores with minimum of 0 meaning no effect on quality of life and 30 meaning extremely large effect.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in ItchyQoL Total Score Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'KPL-716: CIU Cohort', 'description': 'Participants with CIU received KPL-716 weekly for 8 weeks'}, {'id': 'OG001', 'title': 'Placebo: CIU Cohort', 'description': 'Participants with CIU received placebo weekly for 8 weeks'}, {'id': 'OG002', 'title': 'KPL-716: CIP Cohort', 'description': 'Participants with CIP received KPL-716 weekly for 8 weeks'}, {'id': 'OG003', 'title': 'Placebo: CIP Cohort', 'description': 'Participants with CIP received placebo weekly for 8 weeks'}, {'id': 'OG004', 'title': 'KPL-716: LP Cohort', 'description': 'Participants with LP received KPL-716 weekly for 8 weeks'}, {'id': 'OG005', 'title': 'Placebo: LP Cohort', 'description': 'Participants with LP received placebo weekly for 8 weeks'}, {'id': 'OG006', 'title': 'KPL-716: LSC Cohort', 'description': 'Participants with LSC received KPL-716 weekly for 8 weeks'}, {'id': 'OG007', 'title': 'Placebo: LSC Cohort', 'description': 'Participants with LSC received placebo weekly for 8 weeks'}, {'id': 'OG008', 'title': 'KPL-716: PPs Cohort', 'description': 'Participants with PPs received KPL-716 weekly for 8 weeks'}, {'id': 'OG009', 'title': 'Placebo: PPs Cohort', 'description': 'Participants with PPs received placebo weekly for 8 weeks'}], 'classes': [{'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-17.0', 'spread': '13.07', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '-10.9', 'spread': '3.63', 'groupId': 'OG002'}, {'value': '-18.9', 'spread': '6.25', 'groupId': 'OG003'}, {'value': '-27.3', 'spread': '15.32', 'groupId': 'OG004'}, {'value': '-31.5', 'spread': '13.91', 'groupId': 'OG006'}, {'value': '0.0', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-29.0', 'spread': '5.61', 'groupId': 'OG008'}, {'value': '-16.9', 'spread': '7.04', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-23.3', 'spread': '9.08', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '-17.8', 'spread': '4.61', 'groupId': 'OG002'}, {'value': '-20.8', 'spread': '8.66', 'groupId': 'OG003'}, {'value': '-27.3', 'spread': '15.32', 'groupId': 'OG004'}, {'value': '-38.8', 'spread': '15.84', 'groupId': 'OG006'}, {'value': '-10.0', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-35.8', 'spread': '5.88', 'groupId': 'OG008'}, {'value': '-23.1', 'spread': '7.31', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-22.8', 'spread': '11.74', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '-22.0', 'spread': '5.96', 'groupId': 'OG002'}, {'value': '-19.2', 'spread': '5.78', 'groupId': 'OG003'}, {'value': '-47.0', 'spread': '6.00', 'groupId': 'OG004'}, {'value': '-41.5', 'spread': '11.99', 'groupId': 'OG006'}, {'value': '-18.0', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-35.5', 'spread': '6.54', 'groupId': 'OG008'}, {'value': '-27.3', 'spread': '4.62', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-33.3', 'spread': '11.46', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '-19.9', 'spread': '5.18', 'groupId': 'OG002'}, {'value': '-18.1', 'spread': '6.93', 'groupId': 'OG003'}, {'value': '-50.0', 'spread': '3.00', 'groupId': 'OG004'}, {'value': '-41.5', 'spread': '11.89', 'groupId': 'OG006'}, {'value': '-18.0', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-38.1', 'spread': '5.66', 'groupId': 'OG008'}, {'value': '-29.2', 'spread': '8.15', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-29.3', 'spread': '9.68', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '-25.1', 'spread': '7.18', 'groupId': 'OG002'}, {'value': '-21.4', 'spread': '6.82', 'groupId': 'OG003'}, {'value': '-64.5', 'spread': '14.50', 'groupId': 'OG004'}, {'value': '-46.8', 'spread': '8.62', 'groupId': 'OG006'}, {'value': '-15.0', 'spread': 'NA', 'comment': '1 participant in this cohort.', 'groupId': 'OG007'}, {'value': '-32.9', 'spread': '6.40', 'groupId': 'OG008'}, {'value': '-31.8', 'spread': '8.46', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 18', 'description': 'ItchyQoL focuses on impact of pruritus on daily activities and on the level of psychological stress. It contains 22 items. The frequency items are scored using a 5-point Likert scale ranging from "never" to "all the time". The bother items are scored from 1 (not bothered) to 5 (severely bothered). The recall period in ItchyQoL is the past week. The ItchyQoL total score is defined as the sum of all 22-items scores. Total scores can be classified as little (0-30), mild (31-50), moderate (51-80), and severe (81-110).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in ItchyQoL Total Score Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'KPL-716: CIU Cohort', 'description': 'Participants with CIU received KPL-716 weekly for 8 weeks'}, {'id': 'OG001', 'title': 'Placebo: CIU Cohort', 'description': 'Participants with CIU received placebo weekly for 8 weeks'}, {'id': 'OG002', 'title': 'KPL-716: CIP Cohort', 'description': 'Participants with CIP received KPL-716 weekly for 8 weeks'}, {'id': 'OG003', 'title': 'Placebo: CIP Cohort', 'description': 'Participants with CIP received placebo weekly for 8 weeks'}, {'id': 'OG004', 'title': 'KPL-716: LP Cohort', 'description': 'Participants with LP received KPL-716 weekly for 8 weeks'}, {'id': 'OG005', 'title': 'Placebo: LP Cohort', 'description': 'Participants with LP received placebo weekly for 8 weeks'}, {'id': 'OG006', 'title': 'KPL-716: LSC Cohort', 'description': 'Participants with LSC received KPL-716 weekly for 8 weeks'}, {'id': 'OG007', 'title': 'Placebo: LSC Cohort', 'description': 'Participants with LSC received placebo weekly for 8 weeks'}, {'id': 'OG008', 'title': 'KPL-716: PPs Cohort', 'description': 'Participants with PPs received KPL-716 weekly for 8 weeks'}, {'id': 'OG009', 'title': 'Placebo: PPs Cohort', 'description': 'Participants with PPs received placebo weekly for 8 weeks'}], 'classes': [{'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-21.4', 'spread': '16.56', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '23.57', 'groupId': 'OG001'}, {'value': '-13.0', 'spread': '5.15', 'groupId': 'OG002'}, {'value': '-24.3', 'spread': '6.43', 'groupId': 'OG003'}, {'value': '-29.1', 'spread': '7.02', 'groupId': 'OG004'}, {'value': '-47.8', 'spread': '17.37', 'groupId': 'OG006'}, {'value': '39.7', 'spread': '46.22', 'groupId': 'OG007'}, {'value': '-34.8', 'spread': '5.84', 'groupId': 'OG008'}, {'value': '-14.6', 'spread': '8.32', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-29.2', 'spread': '11.47', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '16.32', 'groupId': 'OG001'}, {'value': '-23.7', 'spread': '7.21', 'groupId': 'OG002'}, {'value': '-26.0', 'spread': '9.01', 'groupId': 'OG003'}, {'value': '-29.1', 'spread': '7.02', 'groupId': 'OG004'}, {'value': '-56.3', 'spread': '23.23', 'groupId': 'OG006'}, {'value': '27.3', 'spread': '61.79', 'groupId': 'OG007'}, {'value': '-42.7', 'spread': '6.29', 'groupId': 'OG008'}, {'value': '-21.9', 'spread': '8.97', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-28.3', 'spread': '14.70', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '20.91', 'groupId': 'OG001'}, {'value': '-29.4', 'spread': '6.30', 'groupId': 'OG002'}, {'value': '-25.0', 'spread': '7.29', 'groupId': 'OG003'}, {'value': '-50.9', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-58.2', 'spread': '15.85', 'groupId': 'OG006'}, {'value': '12.0', 'spread': '42.18', 'groupId': 'OG007'}, {'value': '-42.7', 'spread': '6.58', 'groupId': 'OG008'}, {'value': '-26.0', 'spread': '10.25', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-41.7', 'spread': '14.66', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '20.86', 'groupId': 'OG001'}, {'value': '-26.5', 'spread': '6.61', 'groupId': 'OG002'}, {'value': '-23.2', 'spread': '7.65', 'groupId': 'OG003'}, {'value': '-54.6', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-59.8', 'spread': '12.34', 'groupId': 'OG006'}, {'value': '19.8', 'spread': '32.82', 'groupId': 'OG007'}, {'value': '-45.8', 'spread': '6.06', 'groupId': 'OG008'}, {'value': '-29.4', 'spread': '9.44', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-36.6', 'spread': '12.16', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '17.30', 'groupId': 'OG001'}, {'value': '-32.5', 'spread': '7.93', 'groupId': 'OG002'}, {'value': '-27.6', 'spread': '9.17', 'groupId': 'OG003'}, {'value': '-69.2', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '-63.8', 'spread': '7.49', 'groupId': 'OG006'}, {'value': '10.2', 'spread': '19.94', 'groupId': 'OG007'}, {'value': '-39.6', 'spread': '7.06', 'groupId': 'OG008'}, {'value': '-31.7', 'spread': '11.00', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '0.5195', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-21.1', 'ciLowerLimit': '-68.69', 'ciUpperLimit': '26.43', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '29.04', 'groupDescription': 'Change at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1869', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '11.3', 'ciLowerLimit': '0.34', 'ciUpperLimit': '22.26', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.27', 'groupDescription': 'Change at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2545', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-87.5', 'ciLowerLimit': '-191.75', 'ciUpperLimit': '16.79', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '55.30', 'groupDescription': 'Change at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0643', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-20.2', 'ciLowerLimit': '-33.88', 'ciUpperLimit': '-6.57', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.26', 'groupDescription': 'Change at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2503', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-28.6', 'ciLowerLimit': '-61.52', 'ciUpperLimit': '4.35', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '20.11', 'groupDescription': 'Change at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8468', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '2.3', 'ciLowerLimit': '-13.08', 'ciUpperLimit': '17.62', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.58', 'groupDescription': 'Change at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3755', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-83.6', 'ciLowerLimit': '-222.98', 'ciUpperLimit': '55.18', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '73.93', 'groupDescription': 'Change at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0755', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-20.9', 'ciLowerLimit': '-35.58', 'ciUpperLimit': '-6.15', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.06', 'groupDescription': 'Change at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3486', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-28.6', 'ciLowerLimit': '-70.76', 'ciUpperLimit': '13.65', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '25.77', 'groupDescription': 'Change at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6559', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-4.4', 'ciLowerLimit': '-17.28', 'ciUpperLimit': '8.50', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.69', 'groupDescription': 'Change at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2987', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-70.2', 'ciLowerLimit': '-165.35', 'ciUpperLimit': '24.94', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '50.46', 'groupDescription': 'Change at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1966', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-16.7', 'ciLowerLimit': '-33.29', 'ciUpperLimit': '-0.13', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.43', 'groupDescription': 'Change at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2051', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-41.5', 'ciLowerLimit': '-83.56', 'ciUpperLimit': '0.62', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '25.70', 'groupDescription': 'Change at Week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7511', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-3.3', 'ciLowerLimit': '-16.79', 'ciUpperLimit': '10.25', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.16', 'groupDescription': 'Change at Week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1797', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-79.6', 'ciLowerLimit': '-153.68', 'ciUpperLimit': '-5.59', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '39.27', 'groupDescription': 'Change at Week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1715', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-16.3', 'ciLowerLimit': '-31.61', 'ciUpperLimit': '-1.08', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.45', 'groupDescription': 'Change at Week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1850', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-36.5', 'ciLowerLimit': '-71.47', 'ciUpperLimit': '-1.63', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '21.32', 'groupDescription': 'Change at Week 18', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6907', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-4.9', 'ciLowerLimit': '-21.15', 'ciUpperLimit': '11.29', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.19', 'groupDescription': 'Change at Week 18', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0901', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-74.0', 'ciLowerLimit': '-118.97', 'ciUpperLimit': '-29.02', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '23.85', 'groupDescription': 'Change at Week 18', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5640', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-7.8', 'ciLowerLimit': '-25.64', 'ciUpperLimit': '9.94', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.34', 'groupDescription': 'Change at Week 18', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 18', 'description': 'ItchyQoL focuses on impact of pruritus on daily activities and on the level of psychological stress. It contains 22 items. The frequency items are scored using a 5-point Likert scale ranging from "never" to "all the time". The bother items are scored from 1 (not bothered) to 5 (severely bothered). The recall period in ItchyQoL is the past week. The ItchyQoL total score is defined as the sum of all 22-items scores. Total scores can be classified as little (0-30), mild (31-50), moderate (51-80), and severe (81-110).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed.'}, {'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Weekly Average WI-NRS at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'KPL-716: CIU Cohort', 'description': 'Participants with CIU received KPL-716 weekly for 8 weeks'}, {'id': 'OG001', 'title': 'Placebo: CIU Cohort', 'description': 'Participants with CIU received placebo weekly for 8 weeks'}, {'id': 'OG002', 'title': 'KPL-716: CIP Cohort', 'description': 'Participants with CIP received KPL-716 weekly for 8 weeks'}, {'id': 'OG003', 'title': 'Placebo: CIP Cohort', 'description': 'Participants with CIP received placebo weekly for 8 weeks'}, {'id': 'OG004', 'title': 'KPL-716: LP Cohort', 'description': 'Participants with LP received KPL-716 weekly for 8 weeks'}, {'id': 'OG005', 'title': 'Placebo: LP Cohort', 'description': 'Participants with LP received placebo weekly for 8 weeks'}, {'id': 'OG006', 'title': 'KPL-716: LSC Cohort', 'description': 'Participants with LSC received KPL-716 weekly for 8 weeks'}, {'id': 'OG007', 'title': 'Placebo: LSC Cohort', 'description': 'Participants with LSC received placebo weekly for 8 weeks'}, {'id': 'OG008', 'title': 'KPL-716: PPs Cohort', 'description': 'Participants with PPs received KPL-716 weekly for 8 weeks'}, {'id': 'OG009', 'title': 'Placebo: PPs Cohort', 'description': 'Participants with PPs received placebo weekly for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-50.7', 'spread': '21.56', 'groupId': 'OG000'}, {'value': '-19.0', 'spread': '31.07', 'groupId': 'OG001'}, {'value': '-52.4', 'spread': '9.32', 'groupId': 'OG002'}, {'value': '-48.8', 'spread': '11.63', 'groupId': 'OG003'}, {'value': '-39.4', 'spread': '10.21', 'groupId': 'OG004'}, {'value': '-85.0', 'spread': '11.76', 'groupId': 'OG006'}, {'value': '7.0', 'spread': '26.80', 'groupId': 'OG007'}, {'value': '-66.5', 'spread': '7.78', 'groupId': 'OG008'}, {'value': '-29.0', 'spread': '11.00', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '0.4734', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-31.7', 'ciLowerLimit': '-95.11', 'ciUpperLimit': '31.76', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '38.73', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8130', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-3.6', 'ciLowerLimit': '-23.33', 'ciUpperLimit': '16.18', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '14.91', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0979', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-92.0', 'ciLowerLimit': '-150.60', 'ciUpperLimit': '-33.32', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '31.10', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0122', 'groupIds': ['OG008', 'OG009'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-37.5', 'ciLowerLimit': '-55.48', 'ciUpperLimit': '-19.61', 'pValueComment': 'Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.48', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 8', 'description': 'WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'KPL-716', 'description': 'KPL-716 weekly for 8 weeks'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo weekly for 8 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'Participants With Chronic Idiopathic Urticaria (CIU)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Participants With Chronic Idiopathic Pruritus (CIP)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Participants With Lichen Planus (LP)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Participants With Lichen Simplex Chronicus (LSC)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Participants With Plaque Psoriasis (PPs)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other, Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'This study assigned participants to active treatment or placebo in 5 individual disease-specific cohorts: chronic idiopathic urticaria (CIU), chronic idiopathic pruritus (CIP), lichen planus (LP), lichen simplex chronicus (LSC) and plaque psoriasis (PPs). The participant flow data are presented by combined cohorts for public reporting purposes because the low numbers of participants in the individual disease-specific cohorts may cause re-identification concerns if presented separately.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'KPL-716', 'description': 'KPL-716 weekly for 8 weeks'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo weekly for 8 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.1', 'spread': '11.51', 'groupId': 'BG000'}, {'value': '53.3', 'spread': '13.94', 'groupId': 'BG001'}, {'value': '53.2', 'spread': '12.24', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weekly Average of Daily Worst Itch-Numeric Rating Scale (WI-NRS)', 'classes': [{'categories': [{'measurements': [{'value': '8.1', 'spread': '0.93', 'groupId': 'BG000'}, {'value': '8.3', 'spread': '1.14', 'groupId': 'BG001'}, {'value': '8.2', 'spread': '1.00', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores of Day -6 to Day 1 were averaged.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The baseline characteristics data are presented by combined cohorts for public reporting purposes because the low numbers of participants in the individual disease-specific cohorts may cause re-identification concerns if presented separately.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-28', 'size': 4858000, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-10-14T13:40', 'hasProtocol': True}, {'date': '2020-04-13', 'size': 1175066, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-10-14T13:41', 'hasProtocol': False}]}}, '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': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2020-06-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-04', 'studyFirstSubmitDate': '2019-02-27', 'resultsFirstSubmitDate': '2021-10-14', 'studyFirstSubmitQcDate': '2019-02-27', 'lastUpdatePostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-11-29', 'studyFirstPostDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Weekly Average WI-NRS at Week 8', 'timeFrame': 'Baseline, Week 8', 'description': 'WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.'}, {'measure': 'Percent Change From Baseline in Weekly Average WI-NRS at Week 8', 'timeFrame': 'Baseline, Week 8', 'description': 'WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Weekly Average WI-NRS Over Time', 'timeFrame': 'Baseline, Weeks 1-18', 'description': 'WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.'}, {'measure': 'Percent Change From Baseline in Weekly Average WI-NRS Over Time', 'timeFrame': 'Baseline, Weeks 1-18', 'description': 'WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time', 'timeFrame': 'Baseline, Weeks 1-8, 10, 12, 14, 16, 18', 'description': 'Participants were asked to place a line perpendicular to the VAS line at the point that represents the intensity of their average pruritus experienced over the previous 3 days using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus.'}, {'measure': 'Percent Change From Baseline in Pruritus VAS Over Time', 'timeFrame': 'Baseline, Weeks 1-8, 10, 12, 14, 16, 18', 'description': 'Participants were asked to place a line perpendicular to the VAS line at the point that represents the intensity of their average pruritus experienced over the previous 3 days using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus.'}, {'measure': 'Change From Baseline in 5-D Pruritus Total Score Over Time', 'timeFrame': 'Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18', 'description': 'This tool evaluates pruritus in 5 domains: duration, degree, direction, disability and distribution. Duration, degree and direction each consist of 1 item. The disability domain contains 4 items and the distribution domain includes 16 items. The first 4 domains are measured on a 5-point Likert scale. The scores from each domain are added together to obtain a total 5-D score ranging from 5 (no pruritus) and 25 (most severe pruritus).'}, {'measure': 'Percent Change From Baseline in 5-D Pruritus Total Score Over Time', 'timeFrame': 'Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18', 'description': 'This tool evaluates pruritus in 5 domains: duration, degree, direction, disability and distribution. Duration, degree and direction each consist of 1 item. The disability domain contains 4 items and the distribution domain includes 16 items. The first 4 domains are measured on a 5-point Likert scale. The scores from each domain are added together to obtain a total 5-D score ranging from 5 (no pruritus) and 25 (most severe pruritus).'}, {'measure': 'Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time', 'timeFrame': 'Baseline, Weeks 1-18', 'description': 'WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only', 'timeFrame': 'Baseline, Weeks 1-18', 'description': 'Participants were asked daily to self-assess the intensity of their pruritus on a Weekly Average Itch Severity Score, which is a Component of Urticaria Activity Score 7 (UAS7). The score for pruritis was graded from 0 (none) to 3 (intense), which was averaged over 7 consecutive days. The greater the severity of the disease the higher the score. Per protocol, the UAS7 tool was completed only by participants in the CIU Cohort.'}, {'measure': 'Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only', 'timeFrame': 'Baseline, Weeks 1-18', 'description': 'Participants were asked daily to self-assess the intensity of their pruritus on a Weekly Average Itch Severity Score, which is a Component of Urticaria Activity Score 7 (UAS7). The score for pruritis was graded from 0 (none) to 3 (intense), which was averaged over 7 consecutive days. The greater the severity of the disease the higher the score. Per protocol, the UAS7 tool was completed only by participants in the CIU Cohort'}, {'measure': 'Change From Baseline in Sleep Loss VAS Over Time', 'timeFrame': 'Baseline, Weeks 1-8, 10, 12, 14, 16, 18', 'description': 'Participants were asked to place a line perpendicular to the VAS line at the point that represents the intensity of their average sleeplessness experienced over the previous 3 nights using a scale from 0 to 10, with 0 indicating no sleeplessness and 10 indicating the worst imaginable sleeplessness at every visit.'}, {'measure': 'Percent Change From Baseline in Sleep Loss VAS Over Time', 'timeFrame': 'Baseline, Weeks 1-8, 10, 12, 14, 16, 18', 'description': 'Participants were asked to place a line perpendicular to the VAS line at the point that represents the intensity of their average sleeplessness experienced over the previous 3 nights using a scale from 0 to 10, with 0 indicating no sleeplessness and 10 indicating the worst imaginable sleeplessness at every visit.'}, {'measure': 'Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time', 'timeFrame': 'Baseline, Weeks 1-18', 'description': 'Participants were asked daily to assign a numerical score to the intensity of their difficulty falling asleep last night due to itch using a scale from 0 to 10, with 0 indicating not difficult at all and 10 indicating extremely difficult.'}, {'measure': 'Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time', 'timeFrame': 'Baseline, Weeks 1-18', 'description': 'Participants were asked daily to assign a numerical score to the intensity of their difficulty falling asleep last night due to itch using a scale from 0 to 10, with 0 indicating not difficult at all and 10 indicating extremely difficult.'}, {'measure': 'Change From Baseline in Weekly Average of Sleep Quality NRS Over Time', 'timeFrame': 'Baseline, Weeks 1-18', 'description': 'Participants were asked daily to assign a numerical score to the quality of their sleep in the previous night using a scale from 0 to 10, with 0 indicating best possible sleep and 10 indicating worst possible sleep.'}, {'measure': 'Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time', 'timeFrame': 'Baseline, Weeks 1-18', 'description': 'Participants were asked daily to assign a numerical score to the quality of their sleep in the previous night using a scale from 0 to 10, with 0 indicating best possible sleep and 10 indicating worst possible sleep.'}, {'measure': 'Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 18', 'description': 'The DLQI is a 10-question questionnaire that considers symptoms and feelings, daily activities, leisure, school, personal relationships, and treatment. Each question, except question 7, is answered on a scale of 0 to 3 (0 for not at all, 1 for a little, 2 for a lot, and 3 for very much), taking into account the previous week. For question 7: participants were asked "Over the last week, has your skin prevented you from working or studying?" If answered yes, score=3; If no, a second question will be asked: "Over the last week how much has your skin been a problem at work or studying?" If further answered a lot, score=2; if a little, score=1; if not at all or not relevant, score=0. The DLQI total score is defined as the sum of all 10-question scores with minimum of 0 meaning no effect on quality of life and 30 meaning extremely large effect.'}, {'measure': 'Percent Change From Baseline in DLQI Total Score Over Time', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 18', 'description': 'The DLQI is a 10-question questionnaire that considers symptoms and feelings, daily activities, leisure, school, personal relationships, and treatment. Each question, except question 7, is answered on a scale of 0 to 3 (0 for not at all, 1 for a little, 2 for a lot, and 3 for very much), taking into account the previous week. For question 7: participants were asked "Over the last week, has your skin prevented you from working or studying?" If answered yes, score=3; If no, a second question will be asked: "Over the last week how much has your skin been a problem at work or studying?" If further answered a lot, score=2; if a little, score=1; if not at all or not relevant, score=0. The DLQI total score is defined as the sum of all 10-question scores with minimum of 0 meaning no effect on quality of life and 30 meaning extremely large effect.'}, {'measure': 'Change From Baseline in ItchyQoL Total Score Over Time', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 18', 'description': 'ItchyQoL focuses on impact of pruritus on daily activities and on the level of psychological stress. It contains 22 items. The frequency items are scored using a 5-point Likert scale ranging from "never" to "all the time". The bother items are scored from 1 (not bothered) to 5 (severely bothered). The recall period in ItchyQoL is the past week. The ItchyQoL total score is defined as the sum of all 22-items scores. Total scores can be classified as little (0-30), mild (31-50), moderate (51-80), and severe (81-110).'}, {'measure': 'Percent Change From Baseline in ItchyQoL Total Score Over Time', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 18', 'description': 'ItchyQoL focuses on impact of pruritus on daily activities and on the level of psychological stress. It contains 22 items. The frequency items are scored using a 5-point Likert scale ranging from "never" to "all the time". The bother items are scored from 1 (not bothered) to 5 (severely bothered). The recall period in ItchyQoL is the past week. The ItchyQoL total score is defined as the sum of all 22-items scores. Total scores can be classified as little (0-30), mild (31-50), moderate (51-80), and severe (81-110).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pruritus, chronic pruritus, moderate to severe'], 'conditions': ['Chronic Idiopathic Urticaria', 'Chronic Idiopathic Pruritus', 'Lichen Planus', 'Lichen Simplex Chronicus', 'Plaque Psoriasis']}, 'descriptionModule': {'briefSummary': 'Participants with diseases characterized by chronic pruritus experiencing moderate to severe pruritus will be enrolled in this pilot Phase 2 study.\n\nThe diseases characterized by chronic pruritus investigated in this pilot study currently include chronic idiopathic urticaria (CIU), chronic idiopathic pruritus (CIP), lichen planus (LP), lichen simplex chronicus (LSC) and plaque psoriasis (PPs).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female aged 18 to 75 years\n2. Have clinical diagnosis of chronic idiopathic urticaria (CIU), chronic idiopathic pruritus (CIP), lichen planus (LP), lichen simplex chronicus (LSC) and plaque psoriasis (PPs) for at least 6 months\n3. Moderate to severe pruritus\n4. Female participants of childbearing potential must have a negative pregnancy test, be nonlactating, and have agreed to use a highly effective method of contraception, as specified in the protocol, from the Screening Visit until 10 weeks after final study drug administration\n5. Able to comprehend and willing to sign an Informed Consent Form and able to abide by the study restrictions and comply with all study procedures for the duration of the study\n\nExclusion Criteria:\n\n1. Use of prohibited medications within the indicated timeframe from Day 1 to the End of Study\n2. Is currently using medication known to cause pruritus\n3. Has any inflammatory, pruritic, and/or fibrotic skin condition other than the diagnosis that defines inclusion\n4. Laboratory abnormalities that fall outside the windows specified in the protocol at the Screening Visit\n5. Has an active infection, including skin infection\n6. Any medical or psychiatric condition which, in the opinion of the Investigator or the Sponsor, may place the participant at increased risk as a result of study participation, interfere with study participation or study assessments, affect compliance with study requirements, or complicate interpretation of study results'}, 'identificationModule': {'nctId': 'NCT03858634', 'briefTitle': 'A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'KPL-716-C202: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Pilot Study to Investigate the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Diseases Characterized by Chronic Pruritus', 'orgStudyIdInfo': {'id': 'KPL-716-C202'}, 'secondaryIdInfos': [{'id': 'GX45045', 'type': 'OTHER', 'domain': 'Genentech, Inc.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KPL-716', 'description': 'Weekly for 8 weeks', 'interventionNames': ['Drug: KPL-716']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Weekly for 8 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'KPL-716', 'type': 'DRUG', 'otherNames': ['Vixarelimab', 'RG6536'], 'description': 'A loading dose of KPL-716 720 mg (2x maintenance dose) administered via 2 subcutaneous (SC) injections within 30 minutes on Day 1. All subsequent doses of KPL-716 (360 mg maintenance dose) administered via a single SC injection.', 'armGroupLabels': ['KPL-716']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo dose administered via 2 SC injections within 30 minutes on Day 1. 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