Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-02-27 @ 2:20 PM
Study NCT ID:
NCT02637557
Status:
COMPLETED
Last Update Posted:
2019-10-15
First Post:
2015-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Trial of IW-3718 for 8 Weeks in Patients With Symptomatic Gastroesophageal Reflux Disease (GERD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Info@ironwoodpharma.com', 'phone': '1 (617) 621-7722', 'title': 'IW-3718-202 Study Chair', 'organization': 'Ironwood Pharmaceuticals, Inc.'}, 'certainAgreement': {'otherDetails': 'All data generated in this study will be the property of Ironwood. Publication of the results by the Principal Investigator will be subject to mutual agreement between the Investigator and Ironwood.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the first dose of study drug through Week 8/End-of-treatment (Day 57 + 3 days) plus 7 days.', 'description': 'Treatment-emergent adverse events (TEAEs) are presented. TEAEs are defined as adverse events (AEs) that started after the first dose of study drug or started before the first dose of study drug but increased in severity after the first dose of study drug. Safety population: all participants who were randomized and received at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo BID', 'description': 'Matching placebo BID', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 16, 'seriousNumAtRisk': 70, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': '500 mg IW-3718 BID', 'description': '500 mg IW-3718 BID', 'otherNumAtRisk': 71, 'deathsNumAtRisk': 71, 'otherNumAffected': 17, 'seriousNumAtRisk': 71, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': '1000 mg IW-3718 BID', 'description': '1000 mg IW-3718 BID', 'otherNumAtRisk': 71, 'deathsNumAtRisk': 71, 'otherNumAffected': 19, 'seriousNumAtRisk': 71, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': '1500 mg IW-3718 BID', 'description': '1500 mg IW-3718 BID', 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 12, 'seriousNumAtRisk': 68, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Selective abortion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline to Week 8 in Weekly Heartburn Severity Score (WHSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo BID', 'description': 'Matching placebo BID'}, {'id': 'OG001', 'title': '500 mg IW-3718 BID', 'description': '500 mg IW-3718 BID'}, {'id': 'OG002', 'title': '1000 mg IW-3718 BID', 'description': '1000 mg IW-3718 BID'}, {'id': 'OG003', 'title': '1500 mg IW-3718 BID', 'description': '1500 mg IW-3718 BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-46.026', 'spread': '4.078', 'groupId': 'OG000'}, {'value': '-48.978', 'spread': '4.019', 'groupId': 'OG001'}, {'value': '-55.063', 'spread': '4.024', 'groupId': 'OG002'}, {'value': '-57.969', 'spread': '4.108', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.6065', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.952', 'ciLowerLimit': '-14.222', 'ciUpperLimit': '8.318', 'pValueComment': 'P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1160', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.036', 'ciLowerLimit': '-20.318', 'ciUpperLimit': '2.245', 'pValueComment': 'P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0400', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.943', 'ciLowerLimit': '-23.334', 'ciUpperLimit': '-0.551', 'pValueComment': 'P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0225', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'pValueComment': 'Dose trend test performed using linear contrast statement.', 'statisticalMethod': 'trend test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 8', 'description': 'The WHSS for an analysis week was defined as the average of available DHSS during that week. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'percentage change in score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values both at baseline and during the Treatment Period.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 4 in WHSS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo BID', 'description': 'Matching placebo BID'}, {'id': 'OG001', 'title': '500 mg IW-3718 BID', 'description': '500 mg IW-3718 BID'}, {'id': 'OG002', 'title': '1000 mg IW-3718 BID', 'description': '1000 mg IW-3718 BID'}, {'id': 'OG003', 'title': '1500 mg IW-3718 BID', 'description': '1500 mg IW-3718 BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-38.883', 'spread': '3.733', 'groupId': 'OG000'}, {'value': '-42.594', 'spread': '3.679', 'groupId': 'OG001'}, {'value': '-41.622', 'spread': '3.683', 'groupId': 'OG002'}, {'value': '-47.486', 'spread': '3.761', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.4795', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.711', 'ciLowerLimit': '-14.028', 'ciUpperLimit': '6.606', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6020', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.739', 'ciLowerLimit': '-13.066', 'ciUpperLimit': '7.588', 'pValueComment': 'P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1055', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.602', 'ciLowerLimit': '-19.030', 'ciUpperLimit': '1.826', 'pValueComment': 'P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1387', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'pValueComment': 'Dose trend test performed using linear contrast statement.', 'statisticalMethod': 'trend test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 4', 'description': 'The WHSS for an analysis week was defined as the average of available DHSS during that week. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'percentage change in score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values both at baseline and during the Treatment Period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 8 in WHSS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo BID', 'description': 'Matching placebo BID'}, {'id': 'OG001', 'title': '500 mg IW-3718 BID', 'description': '500 mg IW-3718 BID'}, {'id': 'OG002', 'title': '1000 mg IW-3718 BID', 'description': '1000 mg IW-3718 BID'}, {'id': 'OG003', 'title': '1500 mg IW-3718 BID', 'description': '1500 mg IW-3718 BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.459', 'spread': '0.129', 'groupId': 'OG000'}, {'value': '-1.517', 'spread': '0.127', 'groupId': 'OG001'}, {'value': '-1.713', 'spread': '0.127', 'groupId': 'OG002'}, {'value': '-1.876', 'spread': '0.130', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.7488', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.058', 'ciLowerLimit': '-0.415', 'ciUpperLimit': '0.299', 'pValueComment': 'P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1627', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.254', 'ciLowerLimit': '-0.611', 'ciUpperLimit': '0.103', 'pValueComment': 'P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0237', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.417', 'ciLowerLimit': '-0.777', 'ciUpperLimit': '-0.056', 'pValueComment': 'P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0130', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'pValueComment': 'Dose trend test performed using linear contrast statement.', 'statisticalMethod': 'trend test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 8', 'description': 'The WHSS for an analysis week was defined as the average of available DHSS during that week. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values both at baseline and during the Treatment Period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 4 in WHSS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo BID', 'description': 'Matching placebo BID'}, {'id': 'OG001', 'title': '500 mg IW-3718 BID', 'description': '500 mg IW-3718 BID'}, {'id': 'OG002', 'title': '1000 mg IW-3718 BID', 'description': '1000 mg IW-3718 BID'}, {'id': 'OG003', 'title': '1500 mg IW-3718 BID', 'description': '1500 mg IW-3718 BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.261', 'spread': '0.115', 'groupId': 'OG000'}, {'value': '-1.313', 'spread': '0.113', 'groupId': 'OG001'}, {'value': '-1.308', 'spread': '0.113', 'groupId': 'OG002'}, {'value': '-1.517', 'spread': '0.115', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.7470', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.052', 'ciLowerLimit': '-0.369', 'ciUpperLimit': '0.265', 'pValueComment': 'P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7699', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.047', 'ciLowerLimit': '-0.364', 'ciUpperLimit': '0.270', 'pValueComment': 'P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1157', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.257', 'ciLowerLimit': '-0.577', 'ciUpperLimit': '0.064', 'pValueComment': 'P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1374', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'pValueComment': 'Dose trend test performed using linear contrast statement.', 'statisticalMethod': 'trend test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 4', 'description': 'The WHSS for an analysis week was defined as the average of available DHSS during that week. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values both at baseline and during the Treatment Period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Are Overall Heartburn Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo BID', 'description': 'Matching placebo BID'}, {'id': 'OG001', 'title': '500 mg IW-3718 BID', 'description': '500 mg IW-3718 BID'}, {'id': 'OG002', 'title': '1000 mg IW-3718 BID', 'description': '1000 mg IW-3718 BID'}, {'id': 'OG003', 'title': '1500 mg IW-3718 BID', 'description': '1500 mg IW-3718 BID'}], 'classes': [{'categories': [{'measurements': [{'value': '54.3', 'groupId': 'OG000', 'lowerLimit': '41.9', 'upperLimit': '66.3'}, {'value': '52.1', 'groupId': 'OG001', 'lowerLimit': '39.9', 'upperLimit': '64.1'}, {'value': '62.0', 'groupId': 'OG002', 'lowerLimit': '49.7', 'upperLimit': '73.2'}, {'value': '66.2', 'groupId': 'OG003', 'lowerLimit': '53.7', 'upperLimit': '77.2'}]}]}], 'analyses': [{'pValue': '0.7903', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.47', 'ciUpperLimit': '1.77', 'pValueComment': 'Odds ratio, 95% confidence interval (CI) for the odds ratio and p-value vs. placebo are obtained from the Cochran-Mantel-Haenszel (CMH) tests controlling for esophagitis status.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3518', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.38', 'ciLowerLimit': '0.70', 'ciUpperLimit': '2.71', 'pValueComment': 'Odds ratio, 95% CI for the odds ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1544', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.64', 'ciLowerLimit': '0.83', 'ciUpperLimit': '3.26', 'pValueComment': 'Odds ratio, 95% CI for the odds ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 8', 'description': 'An overall heartburn responder is a participant who is a weekly heartburn responder for at least 4 of the 8 treatment weeks and for at least 1 of the final 2 treatment weeks (i.e., Week 7 and Week 8). A weekly heartburn responder is a participant with a decrease of \\>= 30% from baseline in WHSS (see Outcome Measure 1 for description of WHSS). A participant who reported heartburn severity for less than 4 days during a week was not considered a responder for that week.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a DHSS of No More Than Very Mild (≤ 1) on Any Day During Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo BID', 'description': 'Matching placebo BID'}, {'id': 'OG001', 'title': '500 mg IW-3718 BID', 'description': '500 mg IW-3718 BID'}, {'id': 'OG002', 'title': '1000 mg IW-3718 BID', 'description': '1000 mg IW-3718 BID'}, {'id': 'OG003', 'title': '1500 mg IW-3718 BID', 'description': '1500 mg IW-3718 BID'}], 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000', 'lowerLimit': '18.4', 'upperLimit': '40.6'}, {'value': '18.3', 'groupId': 'OG001', 'lowerLimit': '10.1', 'upperLimit': '29.3'}, {'value': '29.6', 'groupId': 'OG002', 'lowerLimit': '19.3', 'upperLimit': '41.6'}, {'value': '38.2', 'groupId': 'OG003', 'lowerLimit': '26.7', 'upperLimit': '50.8'}]}]}], 'analyses': [{'pValue': '0.1489', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.56', 'ciLowerLimit': '0.25', 'ciUpperLimit': '1.23', 'pValueComment': 'Odds ratio, 95% CI for the odds ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8891', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.51', 'ciUpperLimit': '2.19', 'pValueComment': 'Odds ratio, 95% CI for the odds ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2237', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.56', 'ciLowerLimit': '0.76', 'ciUpperLimit': '3.20', 'pValueComment': 'Odds ratio, 95% CI for the odds ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 8', 'description': 'DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. A participant who reported heartburn severity for less than 4 days during a week was not considered a responder for that week.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values both at baseline and given treatment week.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a DHSS of No More Than Very Mild (≤ 1) on Any Day During Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo BID', 'description': 'Matching placebo BID'}, {'id': 'OG001', 'title': '500 mg IW-3718 BID', 'description': '500 mg IW-3718 BID'}, {'id': 'OG002', 'title': '1000 mg IW-3718 BID', 'description': '1000 mg IW-3718 BID'}, {'id': 'OG003', 'title': '1500 mg IW-3718 BID', 'description': '1500 mg IW-3718 BID'}], 'classes': [{'categories': [{'measurements': [{'value': '12.9', 'groupId': 'OG000', 'lowerLimit': '6.1', 'upperLimit': '23.0'}, {'value': '15.5', 'groupId': 'OG001', 'lowerLimit': '8.0', 'upperLimit': '26.0'}, {'value': '22.5', 'groupId': 'OG002', 'lowerLimit': '13.5', 'upperLimit': '34.0'}, {'value': '22.1', 'groupId': 'OG003', 'lowerLimit': '12.9', 'upperLimit': '33.8'}]}]}], 'analyses': [{'pValue': '0.6566', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.24', 'ciLowerLimit': '0.48', 'ciUpperLimit': '3.18', 'pValueComment': 'Odds ratio, 95% CI (Confidence Interval) for the Odds Ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1280', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.01', 'ciLowerLimit': '0.81', 'ciUpperLimit': '4.98', 'pValueComment': 'Odds ratio, 95% CI (Confidence Interval) for the Odds Ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1463', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.97', 'ciLowerLimit': '0.79', 'ciUpperLimit': '4.91', 'pValueComment': 'Odds ratio, 95% CI (Confidence Interval) for the Odds Ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'description': 'DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. A participant who reported heartburn severity for less than 4 days during a week was not considered a responder for that week.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at both baseline and given treatment week.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Number of Days Where DHSS Was No More Than Very Mild (≤ 1) During Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo BID', 'description': 'Matching placebo BID'}, {'id': 'OG001', 'title': '500 mg IW-3718 BID', 'description': '500 mg IW-3718 BID'}, {'id': 'OG002', 'title': '1000 mg IW-3718 BID', 'description': '1000 mg IW-3718 BID'}, {'id': 'OG003', 'title': '1500 mg IW-3718 BID', 'description': '1500 mg IW-3718 BID'}], 'classes': [{'categories': [{'measurements': [{'value': '2.998', 'spread': '0.358', 'groupId': 'OG000'}, {'value': '2.700', 'spread': '0.347', 'groupId': 'OG001'}, {'value': '3.250', 'spread': '0.355', 'groupId': 'OG002'}, {'value': '3.510', 'spread': '0.359', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.5504', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.298', 'ciLowerLimit': '-1.279', 'ciUpperLimit': '0.683', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6177', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.252', 'ciLowerLimit': '-0.741', 'ciUpperLimit': '1.244', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3138', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.513', 'ciLowerLimit': '-0.488', 'ciUpperLimit': '1.513', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 8', 'description': 'DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at both baseline and treatment week.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Number of Days Where DHSS Was No More Than Very Mild (≤ 1) During Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo BID', 'description': 'Matching placebo BID'}, {'id': 'OG001', 'title': '500 mg IW-3718 BID', 'description': '500 mg IW-3718 BID'}, {'id': 'OG002', 'title': '1000 mg IW-3718 BID', 'description': '1000 mg IW-3718 BID'}, {'id': 'OG003', 'title': '1500 mg IW-3718 BID', 'description': '1500 mg IW-3718 BID'}], 'classes': [{'categories': [{'measurements': [{'value': '2.275', 'spread': '0.336', 'groupId': 'OG000'}, {'value': '2.294', 'spread': '0.322', 'groupId': 'OG001'}, {'value': '2.694', 'spread': '0.329', 'groupId': 'OG002'}, {'value': '2.736', 'spread': '0.327', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.9675', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.019', 'ciLowerLimit': '-0.897', 'ciUpperLimit': '0.935', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3741', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.419', 'ciLowerLimit': '-0.507', 'ciUpperLimit': '1.345', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3275', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.461', 'ciLowerLimit': '-0.464', 'ciUpperLimit': '1.385', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 4', 'description': 'DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at both baseline and treatment week.'}, {'type': 'SECONDARY', 'title': "Change From Baseline Over Time in the Weekly Average of Modified Reflux Symptom Questionnaire - Electronic Diary (mRESQ-eD) Item 'Heartburn Severity'", 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo BID', 'description': 'Matching placebo BID'}, {'id': 'OG001', 'title': '500 mg IW-3718 BID', 'description': '500 mg IW-3718 BID'}, {'id': 'OG002', 'title': '1000 mg IW-3718 BID', 'description': '1000 mg IW-3718 BID'}, {'id': 'OG003', 'title': '1500 mg IW-3718 BID', 'description': '1500 mg IW-3718 BID'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '-0.655', 'spread': '0.090', 'groupId': 'OG000'}, {'value': '-0.632', 'spread': '0.089', 'groupId': 'OG001'}, {'value': '-0.531', 'spread': '0.089', 'groupId': 'OG002'}, {'value': '-0.673', 'spread': '0.091', 'groupId': 'OG003'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '-0.994', 'spread': '0.102', 'groupId': 'OG000'}, {'value': '-0.974', 'spread': '0.101', 'groupId': 'OG001'}, {'value': '-0.977', 'spread': '0.101', 'groupId': 'OG002'}, {'value': '-1.102', 'spread': '0.103', 'groupId': 'OG003'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '-1.092', 'spread': '0.109', 'groupId': 'OG000'}, {'value': '-1.141', 'spread': '0.107', 'groupId': 'OG001'}, {'value': '-1.153', 'spread': '0.107', 'groupId': 'OG002'}, {'value': '-1.350', 'spread': '0.109', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-1.263', 'spread': '0.112', 'groupId': 'OG000'}, {'value': '-1.281', 'spread': '0.110', 'groupId': 'OG001'}, {'value': '-1.259', 'spread': '0.110', 'groupId': 'OG002'}, {'value': '-1.498', 'spread': '0.112', 'groupId': 'OG003'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '-1.284', 'spread': '0.120', 'groupId': 'OG000'}, {'value': '-1.301', 'spread': '0.119', 'groupId': 'OG001'}, {'value': '-1.339', 'spread': '0.119', 'groupId': 'OG002'}, {'value': '-1.677', 'spread': '0.121', 'groupId': 'OG003'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-1.396', 'spread': '0.121', 'groupId': 'OG000'}, {'value': '-1.343', 'spread': '0.119', 'groupId': 'OG001'}, {'value': '-1.467', 'spread': '0.119', 'groupId': 'OG002'}, {'value': '-1.744', 'spread': '0.122', 'groupId': 'OG003'}]}]}, {'title': 'Week 7', 'categories': [{'measurements': [{'value': '-1.392', 'spread': '0.127', 'groupId': 'OG000'}, {'value': '-1.350', 'spread': '0.125', 'groupId': 'OG001'}, {'value': '-1.436', 'spread': '0.125', 'groupId': 'OG002'}, {'value': '-1.693', 'spread': '0.128', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-1.404', 'spread': '0.127', 'groupId': 'OG000'}, {'value': '-1.482', 'spread': '0.126', 'groupId': 'OG001'}, {'value': '-1.666', 'spread': '0.126', 'groupId': 'OG002'}, {'value': '-1.807', 'spread': '0.128', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.8560', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.023', 'ciLowerLimit': '-0.226', 'ciUpperLimit': '0.272', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3301', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.124', 'ciLowerLimit': '-0.126', 'ciUpperLimit': '0.373', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8845', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.019', 'ciLowerLimit': '-0.270', 'ciUpperLimit': '0.233', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8879', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.020', 'ciLowerLimit': '-0.262', 'ciUpperLimit': '0.303', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9072', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.017', 'ciLowerLimit': '-0.266', 'ciUpperLimit': '0.299', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4573', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.108', 'ciLowerLimit': '-0.393', 'ciUpperLimit': '0.177', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7476', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.049', 'ciLowerLimit': '-0.350', 'ciUpperLimit': '0.251', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6873', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.062', 'ciLowerLimit': '-0.362', 'ciUpperLimit': '0.239', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0952', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.258', 'ciLowerLimit': '-0.562', 'ciUpperLimit': '0.045', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9111', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.018', 'ciLowerLimit': '-0.326', 'ciUpperLimit': '0.291', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9772', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.004', 'ciLowerLimit': '-0.304', 'ciUpperLimit': '0.313', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1390', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.235', 'ciLowerLimit': '-0.546', 'ciUpperLimit': '0.077', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9215', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.017', 'ciLowerLimit': '-0.349', 'ciUpperLimit': '0.316', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7453', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.055', 'ciLowerLimit': '-0.388', 'ciUpperLimit': '0.278', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0220', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.393', 'ciLowerLimit': '-0.729', 'ciUpperLimit': '-0.057', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7561', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.053', 'ciLowerLimit': '-0.282', 'ciUpperLimit': '0.387', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6758', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.071', 'ciLowerLimit': '-0.406', 'ciUpperLimit': '0.263', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0434', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.348', 'ciLowerLimit': '-0.686', 'ciUpperLimit': '-0.010', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8123', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.042', 'ciLowerLimit': '-0.308', 'ciUpperLimit': '0.392', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8038', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.044', 'ciLowerLimit': '-0.394', 'ciUpperLimit': '0.306', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0954', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.300', 'ciLowerLimit': '-0.654', 'ciUpperLimit': '0.053', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6649', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.078', 'ciLowerLimit': '-0.430', 'ciUpperLimit': '0.275', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1448', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.262', 'ciLowerLimit': '-0.614', 'ciUpperLimit': '0.091', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0264', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.403', 'ciLowerLimit': '-0.759', 'ciUpperLimit': '-0.048', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8', 'description': 'The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their heartburn over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at both baseline and treatment week.'}, {'type': 'SECONDARY', 'title': "Change From Baseline Over Time in the Weekly Average of mRESQ-eD Item 'Burning Feeling Behind Breastbone or Center of Upper Stomach Severity'", 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo BID', 'description': 'Matching placebo BID'}, {'id': 'OG001', 'title': '500 mg IW-3718 BID', 'description': '500 mg IW-3718 BID'}, {'id': 'OG002', 'title': '1000 mg IW-3718 BID', 'description': '1000 mg IW-3718 BID'}, {'id': 'OG003', 'title': '1500 mg IW-3718 BID', 'description': '1500 mg IW-3718 BID'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '-0.638', 'spread': '0.089', 'groupId': 'OG000'}, {'value': '-0.536', 'spread': '0.087', 'groupId': 'OG001'}, {'value': '-0.492', 'spread': '0.088', 'groupId': 'OG002'}, {'value': '-0.675', 'spread': '0.089', 'groupId': 'OG003'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '-0.998', 'spread': '0.103', 'groupId': 'OG000'}, {'value': '-0.918', 'spread': '0.101', 'groupId': 'OG001'}, {'value': '-0.970', 'spread': '0.102', 'groupId': 'OG002'}, {'value': '-1.116', 'spread': '0.104', 'groupId': 'OG003'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '-1.040', 'spread': '0.108', 'groupId': 'OG000'}, {'value': '-1.074', 'spread': '0.106', 'groupId': 'OG001'}, {'value': '-1.112', 'spread': '0.107', 'groupId': 'OG002'}, {'value': '-1.385', 'spread': '0.109', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-1.199', 'spread': '0.113', 'groupId': 'OG000'}, {'value': '-1.246', 'spread': '0.112', 'groupId': 'OG001'}, {'value': '-1.316', 'spread': '0.112', 'groupId': 'OG002'}, {'value': '-1.497', 'spread': '0.114', 'groupId': 'OG003'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '-1.226', 'spread': '0.120', 'groupId': 'OG000'}, {'value': '-1.287', 'spread': '0.118', 'groupId': 'OG001'}, {'value': '-1.323', 'spread': '0.118', 'groupId': 'OG002'}, {'value': '-1.648', 'spread': '0.121', 'groupId': 'OG003'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-1.357', 'spread': '0.119', 'groupId': 'OG000'}, {'value': '-1.297', 'spread': '0.117', 'groupId': 'OG001'}, {'value': '-1.450', 'spread': '0.117', 'groupId': 'OG002'}, {'value': '-1.733', 'spread': '0.120', 'groupId': 'OG003'}]}]}, {'title': 'Week 7', 'categories': [{'measurements': [{'value': '-1.310', 'spread': '0.124', 'groupId': 'OG000'}, {'value': '-1.359', 'spread': '0.122', 'groupId': 'OG001'}, {'value': '-1.424', 'spread': '0.122', 'groupId': 'OG002'}, {'value': '-1.676', 'spread': '0.125', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-1.329', 'spread': '0.122', 'groupId': 'OG000'}, {'value': '-1.422', 'spread': '0.120', 'groupId': 'OG001'}, {'value': '-1.627', 'spread': '0.121', 'groupId': 'OG002'}, {'value': '-1.781', 'spread': '0.123', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.4137', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.102', 'ciLowerLimit': '-0.143', 'ciUpperLimit': '0.347', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2395', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.147', 'ciLowerLimit': '-0.098', 'ciUpperLimit': '0.392', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7729', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.036', 'ciLowerLimit': '-0.284', 'ciUpperLimit': '0.212', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5824', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.079', 'ciLowerLimit': '-0.205', 'ciUpperLimit': '0.363', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8466', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.028', 'ciLowerLimit': '-0.256', 'ciUpperLimit': '0.312', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4192', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.118', 'ciLowerLimit': '-0.405', 'ciUpperLimit': '0.169', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8192', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.035', 'ciLowerLimit': '-0.333', 'ciUpperLimit': '0.264', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6320', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.073', 'ciLowerLimit': '-0.372', 'ciUpperLimit': '0.226', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0254', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.345', 'ciLowerLimit': '-0.647', 'ciUpperLimit': '-0.043', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7689', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.047', 'ciLowerLimit': '-0.360', 'ciUpperLimit': '0.266', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4631', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.117', 'ciLowerLimit': '-0.430', 'ciUpperLimit': '0.196', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0651', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.298', 'ciLowerLimit': '-0.615', 'ciUpperLimit': '0.019', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7197', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.060', 'ciLowerLimit': '-0.392', 'ciUpperLimit': '0.271', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5649', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.097', 'ciLowerLimit': '-0.428', 'ciUpperLimit': '0.234', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0138', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.422', 'ciLowerLimit': '-0.757', 'ciUpperLimit': '-0.087', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7202', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.060', 'ciLowerLimit': '-0.269', 'ciUpperLimit': '0.388', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5784', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.093', 'ciLowerLimit': '-0.421', 'ciUpperLimit': '0.236', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0266', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.376', 'ciLowerLimit': '-0.708', 'ciUpperLimit': '-0.044', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7770', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.049', 'ciLowerLimit': '-0.391', 'ciUpperLimit': '0.293', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5121', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.114', 'ciLowerLimit': '-0.456', 'ciUpperLimit': '0.228', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0384', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.366', 'ciLowerLimit': '-0.711', 'ciUpperLimit': '-0.020', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5876', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.093', 'ciLowerLimit': '-0.431', 'ciUpperLimit': '0.245', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0842', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.298', 'ciLowerLimit': '-0.636', 'ciUpperLimit': '0.040', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0098', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.452', 'ciLowerLimit': '-0.793', 'ciUpperLimit': '-0.110', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8', 'description': 'The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their burning feeling behind the breastbone or in the center of the upper stomach over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at both baseline and treatment week.'}, {'type': 'SECONDARY', 'title': "Change From Baseline Over Time in the mRESQ-eD Item 'Pain Behind Breastbone or Center of Upper Stomach Severity'", 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo BID', 'description': 'Matching placebo BID'}, {'id': 'OG001', 'title': '500 mg IW-3718 BID', 'description': '500 mg IW-3718 BID'}, {'id': 'OG002', 'title': '1000 mg IW-3718 BID', 'description': '1000 mg IW-3718 BID'}, {'id': 'OG003', 'title': '1500 mg IW-3718 BID', 'description': '1500 mg IW-3718 BID'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '-0.602', 'spread': '0.089', 'groupId': 'OG000'}, {'value': '-0.548', 'spread': '0.088', 'groupId': 'OG001'}, {'value': '-0.454', 'spread': '0.089', 'groupId': 'OG002'}, {'value': '-0.626', 'spread': '0.090', 'groupId': 'OG003'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '-0.921', 'spread': '0.103', 'groupId': 'OG000'}, {'value': '-0.869', 'spread': '0.101', 'groupId': 'OG001'}, {'value': '-0.934', 'spread': '0.102', 'groupId': 'OG002'}, {'value': '-1.083', 'spread': '0.103', 'groupId': 'OG003'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '-1.002', 'spread': '0.110', 'groupId': 'OG000'}, {'value': '-1.008', 'spread': '0.108', 'groupId': 'OG001'}, {'value': '-1.126', 'spread': '0.109', 'groupId': 'OG002'}, {'value': '-1.313', 'spread': '0.111', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-1.185', 'spread': '0.113', 'groupId': 'OG000'}, {'value': '-1.210', 'spread': '0.111', 'groupId': 'OG001'}, {'value': '-1.244', 'spread': '0.112', 'groupId': 'OG002'}, {'value': '-1.439', 'spread': '0.114', 'groupId': 'OG003'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '-1.279', 'spread': '0.119', 'groupId': 'OG000'}, {'value': '-1.230', 'spread': '0.117', 'groupId': 'OG001'}, {'value': '-1.299', 'spread': '0.118', 'groupId': 'OG002'}, {'value': '-1.578', 'spread': '0.120', 'groupId': 'OG003'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-1.343', 'spread': '0.118', 'groupId': 'OG000'}, {'value': '-1.257', 'spread': '0.117', 'groupId': 'OG001'}, {'value': '-1.367', 'spread': '0.117', 'groupId': 'OG002'}, {'value': '-1.665', 'spread': '0.119', 'groupId': 'OG003'}]}]}, {'title': 'Week 7', 'categories': [{'measurements': [{'value': '-1.252', 'spread': '0.122', 'groupId': 'OG000'}, {'value': '-1.303', 'spread': '0.121', 'groupId': 'OG001'}, {'value': '-1.302', 'spread': '0.121', 'groupId': 'OG002'}, {'value': '-1.638', 'spread': '0.124', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-1.289', 'spread': '0.121', 'groupId': 'OG000'}, {'value': '-1.333', 'spread': '0.119', 'groupId': 'OG001'}, {'value': '-1.525', 'spread': '0.119', 'groupId': 'OG002'}, {'value': '-1.674', 'spread': '0.122', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.6663', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.054', 'ciLowerLimit': '-0.193', 'ciUpperLimit': '0.301', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2400', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.148', 'ciLowerLimit': '-0.100', 'ciUpperLimit': '0.396', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8560', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.023', 'ciLowerLimit': '-0.273', 'ciUpperLimit': '0.227', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7209', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.051', 'ciLowerLimit': '-0.232', 'ciUpperLimit': '0.335', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9283', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.013', 'ciLowerLimit': '-0.297', 'ciUpperLimit': '0.271', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2659', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.162', 'ciLowerLimit': '-0.449', 'ciUpperLimit': '0.124', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9680', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.006', 'ciLowerLimit': '-0.310', 'ciUpperLimit': '0.298', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4213', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.125', 'ciLowerLimit': '-0.429', 'ciUpperLimit': '0.180', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0471', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.311', 'ciLowerLimit': '-0.618', 'ciUpperLimit': '-0.004', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8769', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.025', 'ciLowerLimit': '-0.337', 'ciUpperLimit': '0.288', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7109', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.059', 'ciLowerLimit': '-0.372', 'ciUpperLimit': '0.254', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1146', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.254', 'ciLowerLimit': '-0.570', 'ciUpperLimit': '0.062', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7736', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.048', 'ciLowerLimit': '-0.281', 'ciUpperLimit': '0.378', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9059', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.020', 'ciLowerLimit': '-0.350', 'ciUpperLimit': '0.310', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0779', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.299', 'ciLowerLimit': '-0.633', 'ciUpperLimit': '0.034', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6068', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.086', 'ciLowerLimit': '-0.241', 'ciUpperLimit': '0.412', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8838', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.024', 'ciLowerLimit': '-0.352', 'ciUpperLimit': '0.303', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0556', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.323', 'ciLowerLimit': '-0.653', 'ciUpperLimit': '0.008', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7673', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.051', 'ciLowerLimit': '-0.389', 'ciUpperLimit': '0.287', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7709', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.050', 'ciLowerLimit': '-0.389', 'ciUpperLimit': '0.289', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0273', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.386', 'ciLowerLimit': '-0.728', 'ciUpperLimit': '-0.043', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7950', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.044', 'ciLowerLimit': '-0.378', 'ciUpperLimit': '0.289', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1656', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.236', 'ciLowerLimit': '-0.570', 'ciUpperLimit': '0.098', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0254', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.385', 'ciLowerLimit': '-0.722', 'ciUpperLimit': '-0.048', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8', 'description': 'The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their pain behind the breastbone or in the center of the upper stomach over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at both baseline and treatment week.'}, {'type': 'SECONDARY', 'title': "Change From Baseline Over Time in the mRESQ-eD Item 'Difficulty Swallowing Severity'", 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo BID', 'description': 'Matching placebo BID'}, {'id': 'OG001', 'title': '500 mg IW-3718 BID', 'description': '500 mg IW-3718 BID'}, {'id': 'OG002', 'title': '1000 mg IW-3718 BID', 'description': '1000 mg IW-3718 BID'}, {'id': 'OG003', 'title': '1500 mg IW-3718 BID', 'description': '1500 mg IW-3718 BID'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '-0.498', 'spread': '0.075', 'groupId': 'OG000'}, {'value': '-0.405', 'spread': '0.074', 'groupId': 'OG001'}, {'value': '-0.309', 'spread': '0.074', 'groupId': 'OG002'}, {'value': '-0.519', 'spread': '0.076', 'groupId': 'OG003'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '-0.618', 'spread': '0.088', 'groupId': 'OG000'}, {'value': '-0.566', 'spread': '0.086', 'groupId': 'OG001'}, {'value': '-0.611', 'spread': '0.087', 'groupId': 'OG002'}, {'value': '-0.714', 'spread': '0.088', 'groupId': 'OG003'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '-0.671', 'spread': '0.094', 'groupId': 'OG000'}, {'value': '-0.675', 'spread': '0.092', 'groupId': 'OG001'}, {'value': '-0.817', 'spread': '0.092', 'groupId': 'OG002'}, {'value': '-1.022', 'spread': '0.094', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.737', 'spread': '0.098', 'groupId': 'OG000'}, {'value': '-0.763', 'spread': '0.096', 'groupId': 'OG001'}, {'value': '-0.810', 'spread': '0.096', 'groupId': 'OG002'}, {'value': '-1.061', 'spread': '0.098', 'groupId': 'OG003'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '-0.824', 'spread': '0.098', 'groupId': 'OG000'}, {'value': '-0.850', 'spread': '0.096', 'groupId': 'OG001'}, {'value': '-0.846', 'spread': '0.096', 'groupId': 'OG002'}, {'value': '-1.156', 'spread': '0.098', 'groupId': 'OG003'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-0.883', 'spread': '0.102', 'groupId': 'OG000'}, {'value': '-0.805', 'spread': '0.100', 'groupId': 'OG001'}, {'value': '-0.961', 'spread': '0.100', 'groupId': 'OG002'}, {'value': '-1.174', 'spread': '0.102', 'groupId': 'OG003'}]}]}, {'title': 'Week 7', 'categories': [{'measurements': [{'value': '-0.849', 'spread': '0.107', 'groupId': 'OG000'}, {'value': '-0.756', 'spread': '0.105', 'groupId': 'OG001'}, {'value': '-0.906', 'spread': '0.106', 'groupId': 'OG002'}, {'value': '-1.166', 'spread': '0.108', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-0.864', 'spread': '0.107', 'groupId': 'OG000'}, {'value': '-0.822', 'spread': '0.105', 'groupId': 'OG001'}, {'value': '-0.989', 'spread': '0.105', 'groupId': 'OG002'}, {'value': '-1.197', 'spread': '0.107', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.3788', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.093', 'ciLowerLimit': '-0.114', 'ciUpperLimit': '0.300', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0761', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.189', 'ciLowerLimit': '-0.020', 'ciUpperLimit': '0.397', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8415', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.021', 'ciLowerLimit': '-0.232', 'ciUpperLimit': '0.189', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6719', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.052', 'ciLowerLimit': '-0.190', 'ciUpperLimit': '0.294', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9549', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.007', 'ciLowerLimit': '-0.237', 'ciUpperLimit': '0.251', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4408', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.096', 'ciLowerLimit': '-0.342', 'ciUpperLimit': '0.149', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9736', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.004', 'ciLowerLimit': '-0.262', 'ciUpperLimit': '0.253', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2703', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.146', 'ciLowerLimit': '-0.405', 'ciUpperLimit': '0.114', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0087', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.351', 'ciLowerLimit': '-0.612', 'ciUpperLimit': '-0.089', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8480', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.026', 'ciLowerLimit': '-0.295', 'ciUpperLimit': '0.243', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5966', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.073', 'ciLowerLimit': '-0.344', 'ciUpperLimit': '0.198', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0203', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.324', 'ciLowerLimit': '-0.596', 'ciUpperLimit': '-0.051', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8540', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.025', 'ciLowerLimit': '-0.294', 'ciUpperLimit': '0.244', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8757', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.022', 'ciLowerLimit': '-0.293', 'ciUpperLimit': '0.250', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0174', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.332', 'ciLowerLimit': '-0.605', 'ciUpperLimit': '-0.059', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5831', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.078', 'ciLowerLimit': '-0.202', 'ciUpperLimit': '0.358', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5859', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.078', 'ciLowerLimit': '-0.360', 'ciUpperLimit': '0.204', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0447', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.291', 'ciLowerLimit': '-0.575', 'ciUpperLimit': '-0.007', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5365', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.093', 'ciLowerLimit': '-0.203', 'ciUpperLimit': '0.388', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7067', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.057', 'ciLowerLimit': '-0.355', 'ciUpperLimit': '0.241', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0386', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.317', 'ciLowerLimit': '-0.616', 'ciUpperLimit': '-0.017', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7804', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.042', 'ciLowerLimit': '-0.253', 'ciUpperLimit': '0.336', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4064', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.125', 'ciLowerLimit': '-0.422', 'ciUpperLimit': '0.171', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0289', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.333', 'ciLowerLimit': '-0.632', 'ciUpperLimit': '-0.035', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8', 'description': 'The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their difficulty swallowing over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at both baseline and treatment week.'}, {'type': 'SECONDARY', 'title': "Change From Baseline Over Time in the mRESQ-eD Item 'Hoarseness Severity'", 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo BID', 'description': 'Matching placebo BID'}, {'id': 'OG001', 'title': '500 mg IW-3718 BID', 'description': '500 mg IW-3718 BID'}, {'id': 'OG002', 'title': '1000 mg IW-3718 BID', 'description': '1000 mg IW-3718 BID'}, {'id': 'OG003', 'title': '1500 mg IW-3718 BID', 'description': '1500 mg IW-3718 BID'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '-0.329', 'spread': '0.074', 'groupId': 'OG000'}, {'value': '-0.292', 'spread': '0.073', 'groupId': 'OG001'}, {'value': '-0.400', 'spread': '0.073', 'groupId': 'OG002'}, {'value': '-0.406', 'spread': '0.074', 'groupId': 'OG003'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '-0.483', 'spread': '0.090', 'groupId': 'OG000'}, {'value': '-0.416', 'spread': '0.089', 'groupId': 'OG001'}, {'value': '-0.605', 'spread': '0.089', 'groupId': 'OG002'}, {'value': '-0.544', 'spread': '0.091', 'groupId': 'OG003'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '-0.526', 'spread': '0.095', 'groupId': 'OG000'}, {'value': '-0.574', 'spread': '0.094', 'groupId': 'OG001'}, {'value': '-0.796', 'spread': '0.094', 'groupId': 'OG002'}, {'value': '-0.778', 'spread': '0.096', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.505', 'spread': '0.102', 'groupId': 'OG000'}, {'value': '-0.631', 'spread': '0.101', 'groupId': 'OG001'}, {'value': '-0.842', 'spread': '0.101', 'groupId': 'OG002'}, {'value': '-0.833', 'spread': '0.103', 'groupId': 'OG003'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '-0.588', 'spread': '0.107', 'groupId': 'OG000'}, {'value': '-0.684', 'spread': '0.106', 'groupId': 'OG001'}, {'value': '-0.870', 'spread': '0.106', 'groupId': 'OG002'}, {'value': '-0.842', 'spread': '0.108', 'groupId': 'OG003'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-0.617', 'spread': '0.110', 'groupId': 'OG000'}, {'value': '-0.677', 'spread': '0.108', 'groupId': 'OG001'}, {'value': '-0.990', 'spread': '0.108', 'groupId': 'OG002'}, {'value': '-0.962', 'spread': '0.110', 'groupId': 'OG003'}]}]}, {'title': 'Week 7', 'categories': [{'measurements': [{'value': '-0.570', 'spread': '0.111', 'groupId': 'OG000'}, {'value': '-0.626', 'spread': '0.109', 'groupId': 'OG001'}, {'value': '-0.860', 'spread': '0.109', 'groupId': 'OG002'}, {'value': '-1.054', 'spread': '0.111', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-0.604', 'spread': '0.108', 'groupId': 'OG000'}, {'value': '-0.683', 'spread': '0.107', 'groupId': 'OG001'}, {'value': '-0.954', 'spread': '0.107', 'groupId': 'OG002'}, {'value': '-1.086', 'spread': '0.109', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.7207', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.037', 'ciLowerLimit': '-0.167', 'ciUpperLimit': '0.241', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4946', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.071', 'ciLowerLimit': '-0.275', 'ciUpperLimit': '0.133', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4596', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.077', 'ciLowerLimit': '-0.283', 'ciUpperLimit': '0.129', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5987', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.067', 'ciLowerLimit': '-0.182', 'ciUpperLimit': '0.315', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3348', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.122', 'ciLowerLimit': '-0.372', 'ciUpperLimit': '0.127', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6288', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.062', 'ciLowerLimit': '-0.313', 'ciUpperLimit': '0.190', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7193', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.048', 'ciLowerLimit': '-0.312', 'ciUpperLimit': '0.216', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0452', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.270', 'ciLowerLimit': '-0.534', 'ciUpperLimit': '-0.006', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0635', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.252', 'ciLowerLimit': '-0.519', 'ciUpperLimit': '0.014', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3800', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.126', 'ciLowerLimit': '-0.409', 'ciUpperLimit': '0.156', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0200', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.336', 'ciLowerLimit': '-0.620', 'ciUpperLimit': '-0.053', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0244', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.328', 'ciLowerLimit': '-0.614', 'ciUpperLimit': '-0.043', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5232', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.096', 'ciLowerLimit': '-0.392', 'ciUpperLimit': '0.200', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0623', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.282', 'ciLowerLimit': '-0.579', 'ciUpperLimit': '0.015', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0951', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.255', 'ciLowerLimit': '-0.554', 'ciUpperLimit': '0.045', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6985', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.060', 'ciLowerLimit': '-0.363', 'ciUpperLimit': '0.243', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0163', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.373', 'ciLowerLimit': '-0.677', 'ciUpperLimit': '-0.069', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0273', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.345', 'ciLowerLimit': '-0.652', 'ciUpperLimit': '-0.039', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7187', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.056', 'ciLowerLimit': '-0.362', 'ciUpperLimit': '0.250', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0640', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.290', 'ciLowerLimit': '-0.596', 'ciUpperLimit': '0.017', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0023', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.484', 'ciLowerLimit': '-0.793', 'ciUpperLimit': '-0.175', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6033', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.079', 'ciLowerLimit': '-0.378', 'ciUpperLimit': '0.220', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0222', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.350', 'ciLowerLimit': '-0.650', 'ciUpperLimit': '-0.050', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0019', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.482', 'ciLowerLimit': '-0.785', 'ciUpperLimit': '-0.180', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8', 'description': 'The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their hoarseness over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at both baseline and treatment week.'}, {'type': 'SECONDARY', 'title': "Change From Baseline Over Time in the mRESQ-eD Item 'Cough Severity'", 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo BID', 'description': 'Matching placebo BID'}, {'id': 'OG001', 'title': '500 mg IW-3718 BID', 'description': '500 mg IW-3718 BID'}, {'id': 'OG002', 'title': '1000 mg IW-3718 BID', 'description': '1000 mg IW-3718 BID'}, {'id': 'OG003', 'title': '1500 mg IW-3718 BID', 'description': '1500 mg IW-3718 BID'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '-0.426', 'spread': '0.078', 'groupId': 'OG000'}, {'value': '-0.283', 'spread': '0.076', 'groupId': 'OG001'}, {'value': '-0.353', 'spread': '0.076', 'groupId': 'OG002'}, {'value': '-0.389', 'spread': '0.078', 'groupId': 'OG003'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '-0.574', 'spread': '0.095', 'groupId': 'OG000'}, {'value': '-0.501', 'spread': '0.093', 'groupId': 'OG001'}, {'value': '-0.608', 'spread': '0.093', 'groupId': 'OG002'}, {'value': '-0.589', 'spread': '0.095', 'groupId': 'OG003'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '-0.534', 'spread': '0.092', 'groupId': 'OG000'}, {'value': '-0.614', 'spread': '0.090', 'groupId': 'OG001'}, {'value': '-0.745', 'spread': '0.090', 'groupId': 'OG002'}, {'value': '-0.890', 'spread': '0.092', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.530', 'spread': '0.099', 'groupId': 'OG000'}, {'value': '-0.657', 'spread': '0.097', 'groupId': 'OG001'}, {'value': '-0.878', 'spread': '0.097', 'groupId': 'OG002'}, {'value': '-0.914', 'spread': '0.099', 'groupId': 'OG003'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '-0.616', 'spread': '0.106', 'groupId': 'OG000'}, {'value': '-0.692', 'spread': '0.104', 'groupId': 'OG001'}, {'value': '-0.840', 'spread': '0.104', 'groupId': 'OG002'}, {'value': '-0.972', 'spread': '0.107', 'groupId': 'OG003'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-0.634', 'spread': '0.107', 'groupId': 'OG000'}, {'value': '-0.671', 'spread': '0.105', 'groupId': 'OG001'}, {'value': '-0.953', 'spread': '0.105', 'groupId': 'OG002'}, {'value': '-1.026', 'spread': '0.107', 'groupId': 'OG003'}]}]}, {'title': 'Week 7', 'categories': [{'measurements': [{'value': '-0.594', 'spread': '0.112', 'groupId': 'OG000'}, {'value': '-0.688', 'spread': '0.110', 'groupId': 'OG001'}, {'value': '-0.971', 'spread': '0.110', 'groupId': 'OG002'}, {'value': '-1.063', 'spread': '0.112', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-0.613', 'spread': '0.107', 'groupId': 'OG000'}, {'value': '-0.706', 'spread': '0.105', 'groupId': 'OG001'}, {'value': '-0.949', 'spread': '0.105', 'groupId': 'OG002'}, {'value': '-1.158', 'spread': '0.107', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.1922', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.143', 'ciLowerLimit': '-0.072', 'ciUpperLimit': '0.357', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5091', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.072', 'ciLowerLimit': '-0.143', 'ciUpperLimit': '0.288', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7394', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.037', 'ciLowerLimit': '-0.181', 'ciUpperLimit': '0.254', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5845', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.073', 'ciLowerLimit': '-0.189', 'ciUpperLimit': '0.334', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7959', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.034', 'ciLowerLimit': '-0.296', 'ciUpperLimit': '0.228', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9086', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.015', 'ciLowerLimit': '-0.280', 'ciUpperLimit': '0.249', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5334', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.080', 'ciLowerLimit': '-0.333', 'ciUpperLimit': '0.173', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1020', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.212', 'ciLowerLimit': '-0.466', 'ciUpperLimit': '0.042', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0066', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.357', 'ciLowerLimit': '-0.613', 'ciUpperLimit': '-0.100', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3586', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.127', 'ciLowerLimit': '-0.399', 'ciUpperLimit': '0.145', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0128', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.348', 'ciLowerLimit': '-0.621', 'ciUpperLimit': '-0.075', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0064', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.384', 'ciLowerLimit': '-0.660', 'ciUpperLimit': '-0.109', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6124', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.076', 'ciLowerLimit': '-0.369', 'ciUpperLimit': '0.218', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1365', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.223', 'ciLowerLimit': '-0.518', 'ciUpperLimit': '0.071', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0193', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.355', 'ciLowerLimit': '-0.652', 'ciUpperLimit': '-0.058', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8046', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.037', 'ciLowerLimit': '-0.333', 'ciUpperLimit': '0.258', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0350', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.319', 'ciLowerLimit': '-0.616', 'ciUpperLimit': '-0.023', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0105', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.392', 'ciLowerLimit': '-0.691', 'ciUpperLimit': '-0.093', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5482', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.094', 'ciLowerLimit': '-0.403', 'ciUpperLimit': '0.214', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0170', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.377', 'ciLowerLimit': '-0.687', 'ciUpperLimit': '-0.068', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0034', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.469', 'ciLowerLimit': '-0.781', 'ciUpperLimit': '-0.157', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5346', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.093', 'ciLowerLimit': '-0.388', 'ciUpperLimit': '0.202', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0262', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.336', 'ciLowerLimit': '-0.632', 'ciUpperLimit': '-0.040', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0004', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.545', 'ciLowerLimit': '-0.843', 'ciUpperLimit': '-0.246', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8', 'description': 'The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their cough over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at both baseline and treatment week.'}, {'type': 'SECONDARY', 'title': "Change From Baseline Over Time in the mRESQ-eD Item 'Regurgitation Frequency'", 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo BID', 'description': 'Matching placebo BID'}, {'id': 'OG001', 'title': '500 mg IW-3718 BID', 'description': '500 mg IW-3718 BID'}, {'id': 'OG002', 'title': '1000 mg IW-3718 BID', 'description': '1000 mg IW-3718 BID'}, {'id': 'OG003', 'title': '1500 mg IW-3718 BID', 'description': '1500 mg IW-3718 BID'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '-0.483', 'spread': '0.067', 'groupId': 'OG000'}, {'value': '-0.385', 'spread': '0.066', 'groupId': 'OG001'}, {'value': '-0.340', 'spread': '0.066', 'groupId': 'OG002'}, {'value': '-0.511', 'spread': '0.068', 'groupId': 'OG003'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '-0.647', 'spread': '0.082', 'groupId': 'OG000'}, {'value': '-0.637', 'spread': '0.081', 'groupId': 'OG001'}, {'value': '-0.597', 'spread': '0.081', 'groupId': 'OG002'}, {'value': '-0.774', 'spread': '0.083', 'groupId': 'OG003'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '-0.581', 'spread': '0.084', 'groupId': 'OG000'}, {'value': '-0.784', 'spread': '0.083', 'groupId': 'OG001'}, {'value': '-0.791', 'spread': '0.083', 'groupId': 'OG002'}, {'value': '-0.879', 'spread': '0.085', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.769', 'spread': '0.089', 'groupId': 'OG000'}, {'value': '-0.855', 'spread': '0.088', 'groupId': 'OG001'}, {'value': '-0.838', 'spread': '0.087', 'groupId': 'OG002'}, {'value': '-0.984', 'spread': '0.089', 'groupId': 'OG003'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '-0.758', 'spread': '0.087', 'groupId': 'OG000'}, {'value': '-0.869', 'spread': '0.086', 'groupId': 'OG001'}, {'value': '-0.866', 'spread': '0.085', 'groupId': 'OG002'}, {'value': '-1.028', 'spread': '0.087', 'groupId': 'OG003'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-0.834', 'spread': '0.090', 'groupId': 'OG000'}, {'value': '-0.936', 'spread': '0.089', 'groupId': 'OG001'}, {'value': '-0.939', 'spread': '0.089', 'groupId': 'OG002'}, {'value': '-1.093', 'spread': '0.090', 'groupId': 'OG003'}]}]}, {'title': 'Week 7', 'categories': [{'measurements': [{'value': '-0.796', 'spread': '0.090', 'groupId': 'OG000'}, {'value': '-0.899', 'spread': '0.089', 'groupId': 'OG001'}, {'value': '-0.867', 'spread': '0.089', 'groupId': 'OG002'}, {'value': '-1.081', 'spread': '0.091', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-0.811', 'spread': '0.092', 'groupId': 'OG000'}, {'value': '-0.951', 'spread': '0.091', 'groupId': 'OG001'}, {'value': '-1.029', 'spread': '0.091', 'groupId': 'OG002'}, {'value': '-1.191', 'spread': '0.093', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.3007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.098', 'ciLowerLimit': '-0.088', 'ciUpperLimit': '0.284', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1295', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.143', 'ciLowerLimit': '-0.042', 'ciUpperLimit': '0.328', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7671', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.028', 'ciLowerLimit': '-0.216', 'ciUpperLimit': '0.159', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9308', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.010', 'ciLowerLimit': '-0.217', 'ciUpperLimit': '0.238', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6595', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.051', 'ciLowerLimit': '-0.176', 'ciUpperLimit': '0.277', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2771', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.127', 'ciLowerLimit': '-0.356', 'ciUpperLimit': '0.102', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0887', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.203', 'ciLowerLimit': '-0.436', 'ciUpperLimit': '0.031', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0758', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.210', 'ciLowerLimit': '-0.443', 'ciUpperLimit': '0.022', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0132', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.298', 'ciLowerLimit': '-0.534', 'ciUpperLimit': '-0.063', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4903', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.086', 'ciLowerLimit': '-0.332', 'ciUpperLimit': '0.160', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5824', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.068', 'ciLowerLimit': '-0.313', 'ciUpperLimit': '0.176', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0885', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.215', 'ciLowerLimit': '-0.463', 'ciUpperLimit': '0.033', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3652', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.111', 'ciLowerLimit': '-0.352', 'ciUpperLimit': '0.130', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3739', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.108', 'ciLowerLimit': '-0.348', 'ciUpperLimit': '0.131', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0294', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.270', 'ciLowerLimit': '-0.512', 'ciUpperLimit': '-0.027', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4236', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.102', 'ciLowerLimit': '-0.351', 'ciUpperLimit': '0.148', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4071', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.105', 'ciLowerLimit': '-0.353', 'ciUpperLimit': '0.144', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0434', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.259', 'ciLowerLimit': '-0.510', 'ciUpperLimit': '-0.008', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4172', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.103', 'ciLowerLimit': '-0.354', 'ciUpperLimit': '0.147', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5759', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.071', 'ciLowerLimit': '-0.321', 'ciUpperLimit': '0.179', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0271', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.285', 'ciLowerLimit': '-0.538', 'ciUpperLimit': '-0.033', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2804', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.140', 'ciLowerLimit': '-0.395', 'ciUpperLimit': '0.115', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0913', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.218', 'ciLowerLimit': '-0.472', 'ciUpperLimit': '0.035', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0039', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.380', 'ciLowerLimit': '-0.637', 'ciUpperLimit': '-0.123', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8', 'description': 'The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the frequency of their regurgitation (liquid or food moving upwards towards the throat or mouth) over the past 24 hours on a 5-point scale: 0=Never, 1= Rarely, 2=Sometimes, 3=Often, 4=Very often. Daily scores were averaged each week. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at both baseline and treatment week.'}, {'type': 'SECONDARY', 'title': "Change From Baseline Over Time in the mRESQ-eD Item 'Acid or Bitter Taste Frequency'", 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo BID', 'description': 'Matching placebo BID'}, {'id': 'OG001', 'title': '500 mg IW-3718 BID', 'description': '500 mg IW-3718 BID'}, {'id': 'OG002', 'title': '1000 mg IW-3718 BID', 'description': '1000 mg IW-3718 BID'}, {'id': 'OG003', 'title': '1500 mg IW-3718 BID', 'description': '1500 mg IW-3718 BID'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '-0.502', 'spread': '0.069', 'groupId': 'OG000'}, {'value': '-0.374', 'spread': '0.068', 'groupId': 'OG001'}, {'value': '-0.401', 'spread': '0.068', 'groupId': 'OG002'}, {'value': '-0.530', 'spread': '0.070', 'groupId': 'OG003'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '-0.738', 'spread': '0.084', 'groupId': 'OG000'}, {'value': '-0.640', 'spread': '0.082', 'groupId': 'OG001'}, {'value': '-0.676', 'spread': '0.082', 'groupId': 'OG002'}, {'value': '-0.784', 'spread': '0.084', 'groupId': 'OG003'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '-0.691', 'spread': '0.082', 'groupId': 'OG000'}, {'value': '-0.806', 'spread': '0.081', 'groupId': 'OG001'}, {'value': '-0.842', 'spread': '0.081', 'groupId': 'OG002'}, {'value': '-0.874', 'spread': '0.083', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.797', 'spread': '0.090', 'groupId': 'OG000'}, {'value': '-0.847', 'spread': '0.088', 'groupId': 'OG001'}, {'value': '-0.893', 'spread': '0.088', 'groupId': 'OG002'}, {'value': '-0.952', 'spread': '0.090', 'groupId': 'OG003'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '-0.868', 'spread': '0.089', 'groupId': 'OG000'}, {'value': '-0.920', 'spread': '0.087', 'groupId': 'OG001'}, {'value': '-0.929', 'spread': '0.087', 'groupId': 'OG002'}, {'value': '-1.024', 'spread': '0.089', 'groupId': 'OG003'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-0.870', 'spread': '0.092', 'groupId': 'OG000'}, {'value': '-0.966', 'spread': '0.091', 'groupId': 'OG001'}, {'value': '-1.009', 'spread': '0.091', 'groupId': 'OG002'}, {'value': '-1.098', 'spread': '0.093', 'groupId': 'OG003'}]}]}, {'title': 'Week 7', 'categories': [{'measurements': [{'value': '-0.895', 'spread': '0.094', 'groupId': 'OG000'}, {'value': '-0.912', 'spread': '0.092', 'groupId': 'OG001'}, {'value': '-0.947', 'spread': '0.092', 'groupId': 'OG002'}, {'value': '-1.053', 'spread': '0.094', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-0.896', 'spread': '0.094', 'groupId': 'OG000'}, {'value': '-0.938', 'spread': '0.093', 'groupId': 'OG001'}, {'value': '-1.072', 'spread': '0.093', 'groupId': 'OG002'}, {'value': '-1.163', 'spread': '0.095', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.1902', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.128', 'ciLowerLimit': '-0.064', 'ciUpperLimit': '0.319', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3021', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.100', 'ciLowerLimit': '-0.091', 'ciUpperLimit': '0.292', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7750', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.028', 'ciLowerLimit': '-0.221', 'ciUpperLimit': '0.165', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4022', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.099', 'ciLowerLimit': '-0.133', 'ciUpperLimit': '0.330', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5971', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.062', 'ciLowerLimit': '-0.169', 'ciUpperLimit': '0.293', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7024', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.045', 'ciLowerLimit': '-0.279', 'ciUpperLimit': '0.188', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3173', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.115', 'ciLowerLimit': '-0.342', 'ciUpperLimit': '0.111', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1906', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.151', 'ciLowerLimit': '-0.378', 'ciUpperLimit': '0.076', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1177', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.183', 'ciLowerLimit': '-0.412', 'ciUpperLimit': '0.046', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6936', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.050', 'ciLowerLimit': '-0.297', 'ciUpperLimit': '0.198', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4466', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.096', 'ciLowerLimit': '-0.343', 'ciUpperLimit': '0.152', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2225', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.155', 'ciLowerLimit': '-0.405', 'ciUpperLimit': '0.095', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6764', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.052', 'ciLowerLimit': '-0.297', 'ciUpperLimit': '0.193', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6243', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.061', 'ciLowerLimit': '-0.306', 'ciUpperLimit': '0.184', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2151', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.156', 'ciLowerLimit': '-0.403', 'ciUpperLimit': '0.091', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4611', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.096', 'ciLowerLimit': '-0.351', 'ciUpperLimit': '0.160', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2849', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.139', 'ciLowerLimit': '-0.394', 'ciUpperLimit': '0.116', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0833', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.228', 'ciLowerLimit': '-0.485', 'ciUpperLimit': '0.030', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8955', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.017', 'ciLowerLimit': '-0.277', 'ciUpperLimit': '0.242', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6916', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.052', 'ciLowerLimit': '-0.312', 'ciUpperLimit': '0.207', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2345', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.159', 'ciLowerLimit': '-0.421', 'ciUpperLimit': '0.103', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7466', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.043', 'ciLowerLimit': '-0.304', 'ciUpperLimit': '0.218', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1843', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.176', 'ciLowerLimit': '-0.437', 'ciUpperLimit': '0.084', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0471', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.267', 'ciLowerLimit': '-0.531', 'ciUpperLimit': '-0.003', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8', 'description': 'The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the frequency of an acid or bitter taste in the mouth over the past 24 hours on a 5-point scale: 0=Never, 1= Rarely, 2=Sometimes, 3=Often, 4=Very often. Daily scores were averaged each week. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at both baseline and treatment week.'}, {'type': 'SECONDARY', 'title': "Change From Baseline Over Time in the mRESQ-eD Item 'Coughing Frequency'", 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo BID', 'description': 'Matching placebo BID'}, {'id': 'OG001', 'title': '500 mg IW-3718 BID', 'description': '500 mg IW-3718 BID'}, {'id': 'OG002', 'title': '1000 mg IW-3718 BID', 'description': '1000 mg IW-3718 BID'}, {'id': 'OG003', 'title': '1500 mg IW-3718 BID', 'description': '1500 mg IW-3718 BID'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '-0.374', 'spread': '0.064', 'groupId': 'OG000'}, {'value': '-0.286', 'spread': '0.063', 'groupId': 'OG001'}, {'value': '-0.290', 'spread': '0.063', 'groupId': 'OG002'}, {'value': '-0.352', 'spread': '0.064', 'groupId': 'OG003'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '-0.572', 'spread': '0.081', 'groupId': 'OG000'}, {'value': '-0.469', 'spread': '0.079', 'groupId': 'OG001'}, {'value': '-0.484', 'spread': '0.079', 'groupId': 'OG002'}, {'value': '-0.571', 'spread': '0.081', 'groupId': 'OG003'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '-0.477', 'spread': '0.083', 'groupId': 'OG000'}, {'value': '-0.605', 'spread': '0.081', 'groupId': 'OG001'}, {'value': '-0.594', 'spread': '0.081', 'groupId': 'OG002'}, {'value': '-0.729', 'spread': '0.083', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.497', 'spread': '0.089', 'groupId': 'OG000'}, {'value': '-0.667', 'spread': '0.087', 'groupId': 'OG001'}, {'value': '-0.685', 'spread': '0.087', 'groupId': 'OG002'}, {'value': '-0.793', 'spread': '0.089', 'groupId': 'OG003'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '-0.506', 'spread': '0.095', 'groupId': 'OG000'}, {'value': '-0.659', 'spread': '0.093', 'groupId': 'OG001'}, {'value': '-0.648', 'spread': '0.093', 'groupId': 'OG002'}, {'value': '-0.812', 'spread': '0.095', 'groupId': 'OG003'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-0.594', 'spread': '0.092', 'groupId': 'OG000'}, {'value': '-0.653', 'spread': '0.090', 'groupId': 'OG001'}, {'value': '-0.700', 'spread': '0.090', 'groupId': 'OG002'}, {'value': '-0.872', 'spread': '0.092', 'groupId': 'OG003'}]}]}, {'title': 'Week 7', 'categories': [{'measurements': [{'value': '-0.561', 'spread': '0.097', 'groupId': 'OG000'}, {'value': '-0.656', 'spread': '0.095', 'groupId': 'OG001'}, {'value': '-0.713', 'spread': '0.095', 'groupId': 'OG002'}, {'value': '-0.872', 'spread': '0.097', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-0.554', 'spread': '0.095', 'groupId': 'OG000'}, {'value': '-0.647', 'spread': '0.093', 'groupId': 'OG001'}, {'value': '-0.718', 'spread': '0.093', 'groupId': 'OG002'}, {'value': '-0.988', 'spread': '0.095', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.3258', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.088', 'ciLowerLimit': '-0.088', 'ciUpperLimit': '0.265', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3483', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.084', 'ciLowerLimit': '-0.092', 'ciUpperLimit': '0.261', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8055', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.022', 'ciLowerLimit': '-0.156', 'ciUpperLimit': '0.201', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3627', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.103', 'ciLowerLimit': '-0.119', 'ciUpperLimit': '0.326', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4404', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.087', 'ciLowerLimit': '-0.135', 'ciUpperLimit': '0.310', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9939', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.001', 'ciLowerLimit': '-0.224', 'ciUpperLimit': '0.226', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2716', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.128', 'ciLowerLimit': '-0.356', 'ciUpperLimit': '0.100', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3175', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.116', 'ciLowerLimit': '-0.345', 'ciUpperLimit': '0.112', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0325', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.252', 'ciLowerLimit': '-0.483', 'ciUpperLimit': '-0.021', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1769', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.169', 'ciLowerLimit': '-0.415', 'ciUpperLimit': '0.077', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1343', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.188', 'ciLowerLimit': '-0.434', 'ciUpperLimit': '0.058', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0203', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.295', 'ciLowerLimit': '-0.544', 'ciUpperLimit': '-0.046', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2543', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.152', 'ciLowerLimit': '-0.415', 'ciUpperLimit': '0.110', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2892', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.142', 'ciLowerLimit': '-0.405', 'ciUpperLimit': '0.121', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0243', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.306', 'ciLowerLimit': '-0.571', 'ciUpperLimit': '-0.040', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6471', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.059', 'ciLowerLimit': '-0.312', 'ciUpperLimit': '0.194', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4123', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.106', 'ciLowerLimit': '-0.359', 'ciUpperLimit': '0.148', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0338', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.278', 'ciLowerLimit': '-0.534', 'ciUpperLimit': '-0.021', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4841', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.095', 'ciLowerLimit': '-0.362', 'ciUpperLimit': '0.172', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2627', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.152', 'ciLowerLimit': '-0.419', 'ciUpperLimit': '0.115', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0241', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.311', 'ciLowerLimit': '-0.581', 'ciUpperLimit': '-0.041', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4881', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.093', 'ciLowerLimit': '-0.355', 'ciUpperLimit': '0.170', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2205', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.164', 'ciLowerLimit': '-0.427', 'ciUpperLimit': '0.099', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0015', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.433', 'ciLowerLimit': '-0.699', 'ciUpperLimit': '-0.168', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8', 'description': 'The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the frequency of their cough over the past 24 hours on a 5-point scale: 0=Never, 1= Rarely, 2=Sometimes, 3=Often, 4=Very often. Daily scores were averaged each week. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at both baseline and treatment week.'}, {'type': 'SECONDARY', 'title': "Change From Baseline Over Time in the mRESQ-eD Item 'Burping Frequency'", 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo BID', 'description': 'Matching placebo BID'}, {'id': 'OG001', 'title': '500 mg IW-3718 BID', 'description': '500 mg IW-3718 BID'}, {'id': 'OG002', 'title': '1000 mg IW-3718 BID', 'description': '1000 mg IW-3718 BID'}, {'id': 'OG003', 'title': '1500 mg IW-3718 BID', 'description': '1500 mg IW-3718 BID'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '-0.459', 'spread': '0.071', 'groupId': 'OG000'}, {'value': '-0.416', 'spread': '0.070', 'groupId': 'OG001'}, {'value': '-0.309', 'spread': '0.070', 'groupId': 'OG002'}, {'value': '-0.416', 'spread': '0.071', 'groupId': 'OG003'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '-0.669', 'spread': '0.083', 'groupId': 'OG000'}, {'value': '-0.649', 'spread': '0.082', 'groupId': 'OG001'}, {'value': '-0.556', 'spread': '0.082', 'groupId': 'OG002'}, {'value': '-0.614', 'spread': '0.084', 'groupId': 'OG003'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '-0.605', 'spread': '0.085', 'groupId': 'OG000'}, {'value': '-0.705', 'spread': '0.084', 'groupId': 'OG001'}, {'value': '-0.734', 'spread': '0.084', 'groupId': 'OG002'}, {'value': '-0.754', 'spread': '0.086', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.701', 'spread': '0.092', 'groupId': 'OG000'}, {'value': '-0.794', 'spread': '0.091', 'groupId': 'OG001'}, {'value': '-0.797', 'spread': '0.090', 'groupId': 'OG002'}, {'value': '-0.866', 'spread': '0.093', 'groupId': 'OG003'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '-0.744', 'spread': '0.091', 'groupId': 'OG000'}, {'value': '-0.832', 'spread': '0.090', 'groupId': 'OG001'}, {'value': '-0.813', 'spread': '0.090', 'groupId': 'OG002'}, {'value': '-0.910', 'spread': '0.092', 'groupId': 'OG003'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-0.801', 'spread': '0.094', 'groupId': 'OG000'}, {'value': '-0.845', 'spread': '0.093', 'groupId': 'OG001'}, {'value': '-0.845', 'spread': '0.093', 'groupId': 'OG002'}, {'value': '-0.942', 'spread': '0.095', 'groupId': 'OG003'}]}]}, {'title': 'Week 7', 'categories': [{'measurements': [{'value': '-0.810', 'spread': '0.099', 'groupId': 'OG000'}, {'value': '-0.896', 'spread': '0.098', 'groupId': 'OG001'}, {'value': '-0.803', 'spread': '0.097', 'groupId': 'OG002'}, {'value': '-0.909', 'spread': '0.100', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-0.809', 'spread': '0.102', 'groupId': 'OG000'}, {'value': '-0.973', 'spread': '0.101', 'groupId': 'OG001'}, {'value': '-0.920', 'spread': '0.100', 'groupId': 'OG002'}, {'value': '-1.008', 'spread': '0.103', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.6653', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.043', 'ciLowerLimit': '-0.152', 'ciUpperLimit': '0.238', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1327', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.150', 'ciLowerLimit': '-0.046', 'ciUpperLimit': '0.345', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6697', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.043', 'ciLowerLimit': '-0.155', 'ciUpperLimit': '0.241', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8598', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.021', 'ciLowerLimit': '-0.210', 'ciUpperLimit': '0.251', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3354', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.113', 'ciLowerLimit': '-0.118', 'ciUpperLimit': '0.344', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6429', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.055', 'ciLowerLimit': '-0.179', 'ciUpperLimit': '0.289', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4010', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.101', 'ciLowerLimit': '-0.336', 'ciUpperLimit': '0.135', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2821', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.129', 'ciLowerLimit': '-0.364', 'ciUpperLimit': '0.106', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2189', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.149', 'ciLowerLimit': '-0.388', 'ciUpperLimit': '0.089', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4717', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.093', 'ciLowerLimit': '-0.346', 'ciUpperLimit': '0.161', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4572', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.096', 'ciLowerLimit': '-0.349', 'ciUpperLimit': '0.158', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2064', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.165', 'ciLowerLimit': '-0.422', 'ciUpperLimit': '0.092', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4932', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.088', 'ciLowerLimit': '-0.339', 'ciUpperLimit': '0.164', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5897', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.069', 'ciLowerLimit': '-0.321', 'ciUpperLimit': '0.183', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2014', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.166', 'ciLowerLimit': '-0.421', 'ciUpperLimit': '0.089', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7384', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.044', 'ciLowerLimit': '-0.304', 'ciUpperLimit': '0.215', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7423', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.043', 'ciLowerLimit': '-0.303', 'ciUpperLimit': '0.216', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2923', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.141', 'ciLowerLimit': '-0.404', 'ciUpperLimit': '0.122', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5388', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.085', 'ciLowerLimit': '-0.359', 'ciUpperLimit': '0.188', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9565', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.008', 'ciLowerLimit': '-0.266', 'ciUpperLimit': '0.281', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4848', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.099', 'ciLowerLimit': '-0.376', 'ciUpperLimit': '0.179', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2523', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.164', 'ciLowerLimit': '-0.445', 'ciUpperLimit': '0.117', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4356', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.112', 'ciLowerLimit': '-0.393', 'ciUpperLimit': '0.170', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1706', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.199', 'ciLowerLimit': '-0.485', 'ciUpperLimit': '0.086', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8', 'description': 'The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the frequency of their burping over the past 24 hours on a 5-point scale: 0=Never, 1= Rarely, 2=Sometimes, 3=Often, 4=Very often. Daily scores were averaged each week. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at both baseline and treatment week.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Proportion of Heartburn-Free Days During Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo BID', 'description': 'Matching placebo BID'}, {'id': 'OG001', 'title': '500 mg IW-3718 BID', 'description': '500 mg IW-3718 BID'}, {'id': 'OG002', 'title': '1000 mg IW-3718 BID', 'description': '1000 mg IW-3718 BID'}, {'id': 'OG003', 'title': '1500 mg IW-3718 BID', 'description': '1500 mg IW-3718 BID'}], 'classes': [{'categories': [{'measurements': [{'value': '0.276', 'spread': '0.049', 'groupId': 'OG000'}, {'value': '0.256', 'spread': '0.047', 'groupId': 'OG001'}, {'value': '0.310', 'spread': '0.049', 'groupId': 'OG002'}, {'value': '0.347', 'spread': '0.049', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.7689', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.020', 'ciLowerLimit': '-0.155', 'ciUpperLimit': '0.115', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6287', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.034', 'ciLowerLimit': '-0.103', 'ciUpperLimit': '0.170', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3106', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.070', 'ciLowerLimit': '-0.066', 'ciUpperLimit': '0.207', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 8', 'description': 'A heartburn free day was a day where DHSS = 0. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day.', 'unitOfMeasure': 'proportion of days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at treatment week.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Proportion of Heartburn-Free Days During Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo BID', 'description': 'Matching placebo BID'}, {'id': 'OG001', 'title': '500 mg IW-3718 BID', 'description': '500 mg IW-3718 BID'}, {'id': 'OG002', 'title': '1000 mg IW-3718 BID', 'description': '1000 mg IW-3718 BID'}, {'id': 'OG003', 'title': '1500 mg IW-3718 BID', 'description': '1500 mg IW-3718 BID'}], 'classes': [{'categories': [{'measurements': [{'value': '0.141', 'spread': '0.037', 'groupId': 'OG000'}, {'value': '0.142', 'spread': '0.035', 'groupId': 'OG001'}, {'value': '0.134', 'spread': '0.036', 'groupId': 'OG002'}, {'value': '0.241', 'spread': '0.036', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.9961', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.000', 'ciLowerLimit': '-0.100', 'ciUpperLimit': '0.101', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8829', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.008', 'ciLowerLimit': '-0.109', 'ciUpperLimit': '0.094', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0527', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.100', 'ciLowerLimit': '-0.001', 'ciUpperLimit': '0.201', 'pValueComment': 'P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 4', 'description': 'A heartburn free day was a day where DHSS = 0. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day.', 'unitOfMeasure': 'proportion of days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at treatment week.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo BID', 'description': 'Matching placebo twice daily (BID)'}, {'id': 'FG001', 'title': '500 mg IW-3718 BID', 'description': '500 mg IW-3718 BID'}, {'id': 'FG002', 'title': '1000 mg IW-3718 BID', 'description': '1000 mg IW-3718 BID'}, {'id': 'FG003', 'title': '1500 mg IW-3718 BID', 'description': '1500 mg IW-3718 BID'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '71'}, {'groupId': 'FG002', 'numSubjects': '71'}, {'groupId': 'FG003', 'numSubjects': '69'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '62'}, {'groupId': 'FG003', 'numSubjects': '62'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}, {'value': '280', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo BID', 'description': 'Matching placebo BID'}, {'id': 'BG001', 'title': '500 mg IW-3718 BID', 'description': '500 mg IW-3718 BID'}, {'id': 'BG002', 'title': '1000 mg IW-3718 BID', 'description': '1000 mg IW-3718 BID'}, {'id': 'BG003', 'title': '1500 mg IW-3718 BID', 'description': '1500 mg IW-3718 BID'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.5', 'spread': '12.9', 'groupId': 'BG000'}, {'value': '51.4', 'spread': '13.3', 'groupId': 'BG001'}, {'value': '50.1', 'spread': '11.2', 'groupId': 'BG002'}, {'value': '49.4', 'spread': '12.3', 'groupId': 'BG003'}, {'value': '50.1', 'spread': '12.4', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '171', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '109', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '64', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '216', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}, {'value': '232', 'groupId': 'BG004'}]}]}, {'title': 'Other, Not Specified', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weekly Heartburn Severity Score (WHSS)', 'classes': [{'categories': [{'measurements': [{'value': '3.18', 'spread': '0.64', 'groupId': 'BG000'}, {'value': '3.19', 'spread': '0.72', 'groupId': 'BG001'}, {'value': '3.12', 'spread': '0.64', 'groupId': 'BG002'}, {'value': '3.19', 'spread': '0.71', 'groupId': 'BG003'}, {'value': '3.17', 'spread': '0.68', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The WHSS for an analysis week was defined as the average of available Daily Heartburn Severity Scale (DHSS) during that week. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ("Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach") from a particular day.\n\nBaseline was derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Modified Reflux Symptom Questionnaire - Electronic Diary (mRESQ-eD) Item 'Heartburn Severity'", 'classes': [{'categories': [{'measurements': [{'value': '3.08', 'spread': '0.63', 'groupId': 'BG000'}, {'value': '3.01', 'spread': '0.66', 'groupId': 'BG001'}, {'value': '3.00', 'spread': '0.64', 'groupId': 'BG002'}, {'value': '3.08', 'spread': '0.66', 'groupId': 'BG003'}, {'value': '3.04', 'spread': '0.65', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their heartburn over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe.\n\nBaseline was derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "mRESQ-eD Item 'Burning Feeling Behind Breastbone or Center of Upper Stomach Severity'", 'classes': [{'categories': [{'measurements': [{'value': '2.85', 'spread': '0.82', 'groupId': 'BG000'}, {'value': '2.91', 'spread': '0.82', 'groupId': 'BG001'}, {'value': '2.77', 'spread': '0.82', 'groupId': 'BG002'}, {'value': '2.98', 'spread': '0.78', 'groupId': 'BG003'}, {'value': '2.88', 'spread': '0.81', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their burning feeling behind the breastbone or in the center of the upper stomach over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe.\n\nBaseline was derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "mRESQ-eD Item 'Pain Behind Breastbone or Center of Upper Stomach Severity'", 'classes': [{'categories': [{'measurements': [{'value': '2.73', 'spread': '0.87', 'groupId': 'BG000'}, {'value': '2.80', 'spread': '0.89', 'groupId': 'BG001'}, {'value': '2.57', 'spread': '0.95', 'groupId': 'BG002'}, {'value': '2.85', 'spread': '0.91', 'groupId': 'BG003'}, {'value': '2.74', 'spread': '0.91', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their pain behind the breastbone or in the center of the upper stomach over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe.\n\nBaseline was derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "mRESQ-eD Item 'Difficulty Swallowing Severity'", 'classes': [{'categories': [{'measurements': [{'value': '1.71', 'spread': '1.19', 'groupId': 'BG000'}, {'value': '1.81', 'spread': '1.27', 'groupId': 'BG001'}, {'value': '2.15', 'spread': '1.27', 'groupId': 'BG002'}, {'value': '2.05', 'spread': '1.17', 'groupId': 'BG003'}, {'value': '1.93', 'spread': '1.23', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their difficulty swallowing over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe.\n\nBaseline was derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "mRESQ-eD Item 'Hoarseness Severity'", 'classes': [{'categories': [{'measurements': [{'value': '1.75', 'spread': '1.18', 'groupId': 'BG000'}, {'value': '1.81', 'spread': '1.31', 'groupId': 'BG001'}, {'value': '2.00', 'spread': '1.35', 'groupId': 'BG002'}, {'value': '1.81', 'spread': '1.31', 'groupId': 'BG003'}, {'value': '1.84', 'spread': '1.29', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their hoarseness over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe.\n\nBaseline was derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "mRESQ-eD Item 'Cough Severity'", 'classes': [{'categories': [{'measurements': [{'value': '1.78', 'spread': '1.27', 'groupId': 'BG000'}, {'value': '2.11', 'spread': '1.26', 'groupId': 'BG001'}, {'value': '2.21', 'spread': '1.23', 'groupId': 'BG002'}, {'value': '2.16', 'spread': '1.22', 'groupId': 'BG003'}, {'value': '2.07', 'spread': '1.25', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their cough over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe.\n\nBaseline was derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "mRESQ-eD Item 'Regurgitation Frequency'", 'classes': [{'categories': [{'measurements': [{'value': '2.03', 'spread': '0.99', 'groupId': 'BG000'}, {'value': '2.29', 'spread': '0.80', 'groupId': 'BG001'}, {'value': '2.11', 'spread': '0.97', 'groupId': 'BG002'}, {'value': '2.19', 'spread': '0.88', 'groupId': 'BG003'}, {'value': '2.15', 'spread': '0.92', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the frequency of their regurgitation (liquid or food moving upwards towards the throat or mouth) over the past 24 hours on a 5-point scale: 0=Never, 1= Rarely, 2=Sometimes, 3=Often, 4=Very often.\n\nBaseline was derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "mRESQ-eD Item 'Acid or Bitter Taste Frequency'", 'classes': [{'categories': [{'measurements': [{'value': '2.09', 'spread': '1.06', 'groupId': 'BG000'}, {'value': '2.25', 'spread': '0.88', 'groupId': 'BG001'}, {'value': '2.21', 'spread': '0.98', 'groupId': 'BG002'}, {'value': '2.19', 'spread': '1.01', 'groupId': 'BG003'}, {'value': '2.18', 'spread': '0.98', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the frequency of an acid or bitter taste in the mouth over the past 24 hours on a 5-point scale: 0=Never, 1= Rarely, 2=Sometimes, 3=Often, 4=Very often.\n\nBaseline was derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "mRESQ-eD Item 'Coughing Frequency'", 'classes': [{'categories': [{'measurements': [{'value': '1.65', 'spread': '1.10', 'groupId': 'BG000'}, {'value': '1.91', 'spread': '1.06', 'groupId': 'BG001'}, {'value': '1.96', 'spread': '0.99', 'groupId': 'BG002'}, {'value': '1.96', 'spread': '1.00', 'groupId': 'BG003'}, {'value': '1.87', 'spread': '1.04', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the frequency of their cough over the past 24 hours on a 5-point scale: 0=Never, 1= Rarely, 2=Sometimes, 3=Often, 4=Very often.\n\nBaseline was derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "mRESQ-eD Item 'Burping Frequency'", 'classes': [{'categories': [{'measurements': [{'value': '2.26', 'spread': '1.04', 'groupId': 'BG000'}, {'value': '2.21', 'spread': '0.91', 'groupId': 'BG001'}, {'value': '2.33', 'spread': '0.85', 'groupId': 'BG002'}, {'value': '2.51', 'spread': '0.90', 'groupId': 'BG003'}, {'value': '2.33', 'spread': '0.93', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the frequency of their burping over the past 24 hours on a 5-point scale: 0=Never, 1= Rarely, 2=Sometimes, 3=Often, 4=Very often.\n\nBaseline was derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-15', 'size': 1614691, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-09-21T14:27', 'hasProtocol': False}, {'date': '2016-07-27', 'size': 3039520, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-10-14T13:44', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 282}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'dispFirstSubmitDate': '2017-09-25', 'completionDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-14', 'studyFirstSubmitDate': '2015-12-16', 'dispFirstSubmitQcDate': '2017-09-25', 'resultsFirstSubmitDate': '2019-09-23', 'studyFirstSubmitQcDate': '2015-12-18', 'dispFirstPostDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-14', 'studyFirstPostDateStruct': {'date': '2015-12-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline to Week 8 in Weekly Heartburn Severity Score (WHSS)', 'timeFrame': 'Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 8', 'description': 'The WHSS for an analysis week was defined as the average of available DHSS during that week. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. A negative change from Baseline indicates improvement.'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline to Week 4 in WHSS', 'timeFrame': 'Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 4', 'description': 'The WHSS for an analysis week was defined as the average of available DHSS during that week. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. A negative change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline to Week 8 in WHSS', 'timeFrame': 'Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 8', 'description': 'The WHSS for an analysis week was defined as the average of available DHSS during that week. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. A negative change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline to Week 4 in WHSS', 'timeFrame': 'Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 4', 'description': 'The WHSS for an analysis week was defined as the average of available DHSS during that week. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. A negative change from Baseline indicates improvement.'}, {'measure': 'Percentage of Participants Who Are Overall Heartburn Responders', 'timeFrame': 'Week 8', 'description': 'An overall heartburn responder is a participant who is a weekly heartburn responder for at least 4 of the 8 treatment weeks and for at least 1 of the final 2 treatment weeks (i.e., Week 7 and Week 8). A weekly heartburn responder is a participant with a decrease of \\>= 30% from baseline in WHSS (see Outcome Measure 1 for description of WHSS). A participant who reported heartburn severity for less than 4 days during a week was not considered a responder for that week.'}, {'measure': 'Percentage of Participants With a DHSS of No More Than Very Mild (≤ 1) on Any Day During Week 8', 'timeFrame': 'Week 8', 'description': 'DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. A participant who reported heartburn severity for less than 4 days during a week was not considered a responder for that week.'}, {'measure': 'Percentage of Participants With a DHSS of No More Than Very Mild (≤ 1) on Any Day During Week 4', 'timeFrame': 'Week 4', 'description': 'DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. A participant who reported heartburn severity for less than 4 days during a week was not considered a responder for that week.'}, {'measure': 'Change From Baseline in the Number of Days Where DHSS Was No More Than Very Mild (≤ 1) During Week 8', 'timeFrame': 'Week 8', 'description': 'DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day.'}, {'measure': 'Change From Baseline in the Number of Days Where DHSS Was No More Than Very Mild (≤ 1) During Week 4', 'timeFrame': 'Week 4', 'description': 'DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day.'}, {'measure': "Change From Baseline Over Time in the Weekly Average of Modified Reflux Symptom Questionnaire - Electronic Diary (mRESQ-eD) Item 'Heartburn Severity'", 'timeFrame': 'Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8', 'description': 'The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their heartburn over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from Baseline indicates improvement.'}, {'measure': "Change From Baseline Over Time in the Weekly Average of mRESQ-eD Item 'Burning Feeling Behind Breastbone or Center of Upper Stomach Severity'", 'timeFrame': 'Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8', 'description': 'The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their burning feeling behind the breastbone or in the center of the upper stomach over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from baseline indicates improvement.'}, {'measure': "Change From Baseline Over Time in the mRESQ-eD Item 'Pain Behind Breastbone or Center of Upper Stomach Severity'", 'timeFrame': 'Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8', 'description': 'The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their pain behind the breastbone or in the center of the upper stomach over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from baseline indicates improvement.'}, {'measure': "Change From Baseline Over Time in the mRESQ-eD Item 'Difficulty Swallowing Severity'", 'timeFrame': 'Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8', 'description': 'The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their difficulty swallowing over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from baseline indicates improvement.'}, {'measure': "Change From Baseline Over Time in the mRESQ-eD Item 'Hoarseness Severity'", 'timeFrame': 'Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8', 'description': 'The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their hoarseness over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from baseline indicates improvement.'}, {'measure': "Change From Baseline Over Time in the mRESQ-eD Item 'Cough Severity'", 'timeFrame': 'Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8', 'description': 'The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their cough over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from baseline indicates improvement.'}, {'measure': "Change From Baseline Over Time in the mRESQ-eD Item 'Regurgitation Frequency'", 'timeFrame': 'Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8', 'description': 'The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the frequency of their regurgitation (liquid or food moving upwards towards the throat or mouth) over the past 24 hours on a 5-point scale: 0=Never, 1= Rarely, 2=Sometimes, 3=Often, 4=Very often. Daily scores were averaged each week. A negative change from baseline indicates improvement.'}, {'measure': "Change From Baseline Over Time in the mRESQ-eD Item 'Acid or Bitter Taste Frequency'", 'timeFrame': 'Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8', 'description': 'The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the frequency of an acid or bitter taste in the mouth over the past 24 hours on a 5-point scale: 0=Never, 1= Rarely, 2=Sometimes, 3=Often, 4=Very often. Daily scores were averaged each week. A negative change from baseline indicates improvement.'}, {'measure': "Change From Baseline Over Time in the mRESQ-eD Item 'Coughing Frequency'", 'timeFrame': 'Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8', 'description': 'The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the frequency of their cough over the past 24 hours on a 5-point scale: 0=Never, 1= Rarely, 2=Sometimes, 3=Often, 4=Very often. Daily scores were averaged each week. A negative change from baseline indicates improvement.'}, {'measure': "Change From Baseline Over Time in the mRESQ-eD Item 'Burping Frequency'", 'timeFrame': 'Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8', 'description': 'The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the frequency of their burping over the past 24 hours on a 5-point scale: 0=Never, 1= Rarely, 2=Sometimes, 3=Often, 4=Very often. Daily scores were averaged each week. A negative change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in the Proportion of Heartburn-Free Days During Week 8', 'timeFrame': 'Week 8', 'description': 'A heartburn free day was a day where DHSS = 0. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day.'}, {'measure': 'Change From Baseline in the Proportion of Heartburn-Free Days During Week 4', 'timeFrame': 'Week 4', 'description': 'A heartburn free day was a day where DHSS = 0. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Gastroesophageal Reflux Disease']}, 'referencesModule': {'references': [{'pmid': '32092310', 'type': 'DERIVED', 'citation': 'Vaezi MF, Fass R, Vakil N, Reasner DS, Mittleman RS, Hall M, Shao JZ, Chen Y, Lane L, Gates AM, Currie MG. IW-3718 Reduces Heartburn Severity in Patients With Refractory Gastroesophageal Reflux Disease in a Randomized Trial. Gastroenterology. 2020 Jun;158(8):2093-2103. doi: 10.1053/j.gastro.2020.02.031. Epub 2020 Feb 22.'}, {'pmid': '31977454', 'type': 'DERIVED', 'citation': 'Andrae DA, Hanlon J, Cala ML, Scippa K, Graham C, Witherspoon B, Shao JZ, Reasner D. Evaluation and Validation of the Modified Reflux Symptom Questionnaire-Electronic Diary in Patients With Persistent Gastroesophageal Reflux Disease. Clin Transl Gastroenterol. 2020 Jan;11(1):e00117. doi: 10.14309/ctg.0000000000000117.'}]}, 'descriptionModule': {'briefSummary': 'The objectives of this study are to evaluate the safety, efficacy, and dose-response relationship of IW-3718 administered orally to participants who have GERD and continue to experience GERD symptoms while receiving once-daily (QD), standard-dose proton pump inhibitors (PPIs).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is an ambulatory, community-dwelling male or nonpregnant female and is at least 18 years old at the Screening Visit. Lactating females must agree not to breastfeed.\n* Patient has a diagnosis of GERD and reports experiencing GERD symptoms (heartburn or regurgitation) on ≥ 4 days per week during the 8 weeks before the Screening Visit while taking standard QD PPI therapy.\n\nExclusion Criteria:\n\n* Patient may not meet any of the excluded conditions specified in the protocol\n* Patient has any alarm symptoms including but not limited to GI bleeding, anemia, vomiting, dysphagia, or unexpected weight loss any time during the Screening or Pretreatment Periods\n* Patient has a history of clinically significant hypersensitivity or allergies to any of the excipients contained in the study medication (active or placebo).\n\nNOTE: Additional inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02637557', 'briefTitle': 'A Trial of IW-3718 for 8 Weeks in Patients With Symptomatic Gastroesophageal Reflux Disease (GERD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ironwood Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-range-finding Trial of IW-3718 Administered Orally for 8 Weeks to Patients With Symptomatic Gastroesophageal Reflux Disease Not Completely Responsive to Proton Pump Inhibitors', 'orgStudyIdInfo': {'id': 'ICP-3718-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Matching placebo twice daily', 'interventionNames': ['Drug: Matching Placebo', 'Drug: PPI']}, {'type': 'EXPERIMENTAL', 'label': '500 mg IW-3718', 'description': '500 mg IW-3718 twice daily', 'interventionNames': ['Drug: IW-3718', 'Drug: PPI']}, {'type': 'EXPERIMENTAL', 'label': '1000 mg IW-3718', 'description': '1000 mg IW-3718 twice daily', 'interventionNames': ['Drug: IW-3718', 'Drug: PPI']}, {'type': 'EXPERIMENTAL', 'label': '1500 mg IW-3718', 'description': '1500 mg IW-3718 twice daily', 'interventionNames': ['Drug: IW-3718', 'Drug: PPI']}], 'interventions': [{'name': 'IW-3718', 'type': 'DRUG', 'armGroupLabels': ['1000 mg IW-3718', '1500 mg IW-3718', '500 mg IW-3718']}, {'name': 'Matching Placebo', 'type': 'DRUG', 'armGroupLabels': ['Control']}, {'name': 'PPI', 'type': 'DRUG', 'description': 'All participants were taking a standard dose QD PPI (dexlansoprazole, esomeprazole, esomeprazole magnesium, lansoprazole, omeprazole, pantoprazole, pantoprazole sodium sesquihydrate, rabeprazole or rabeprazole sodium) during the study.', 'armGroupLabels': ['1000 mg IW-3718', '1500 mg IW-3718', '500 mg IW-3718', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36305', 'city': 'Dothan', 'state': 'Alabama', 'country': 'United States', 'facility': 'IW-3718 Investigator', 'geoPoint': {'lat': 31.22323, 'lon': -85.39049}}, {'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'IW-3718 Investigator', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85710', 'city': 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