Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-03-13 @ 1:32 AM
Study NCT ID:
NCT01568112
Status:
COMPLETED
Last Update Posted:
2016-06-13
First Post:
2012-03-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Aspirin Pretreatment or Slow Dose Titration on Flushing and Gastrointestinal Events in Healthy Volunteers Receiving Delayed-release Dimethyl Fumarate
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069462', 'term': 'Dimethyl Fumarate'}, {'id': 'D005650', 'term': 'Fumarates'}, {'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D003998', 'term': 'Dicarboxylic Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@biogen.com', 'title': 'Biogen Study Medical Director', 'organization': 'Biogen'}, 'certainAgreement': {'otherDetails': "Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs: from the administration of the first dose of study treatment to the Safety Follow-up (approximately 9 weeks). SAEs: from signing of informed consent to the Safety Follow-up (up to approximately 13 weeks).', 'description': 'Flushing and GI events/symptoms captured separately in the eDiary were not recorded on the AE eCRF unless the events/symptoms led to discontinuation or withdrawal from the study, were classified as SAEs, or were ongoing at the final eDiary entry.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.', 'otherNumAtRisk': 44, 'otherNumAffected': 5, 'seriousNumAtRisk': 44, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'BG00012', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.', 'otherNumAtRisk': 43, 'otherNumAffected': 12, 'seriousNumAtRisk': 43, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'BG00012 + ASA', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.', 'otherNumAtRisk': 43, 'otherNumAffected': 15, 'seriousNumAtRisk': 43, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'BG00012 Slow Titration', 'description': 'Participants received BG00012 for 8 weeks (120 mg once daily \\[QD\\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.', 'otherNumAtRisk': 42, 'otherNumAffected': 12, 'seriousNumAtRisk': 42, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Eosinophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'seriousEvents': [{'term': 'Ovarian germ cell teratoma stage I', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG001', 'title': 'BG00012', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG002', 'title': 'BG00012 + ASA', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.'}, {'id': 'OG003', 'title': 'BG00012 Slow Titration', 'description': 'Participants received BG00012 for 8 weeks (120 mg once daily \\[QD\\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.'}], 'classes': [{'title': 'Overall flushing events', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}]}]}, {'title': 'Overall redness events', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}]}]}, {'title': 'Overall warmth events', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}]}]}, {'title': 'Overall tingling events', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '86', 'groupId': 'OG003'}]}]}, {'title': 'Overall itching events', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9', 'ciLowerLimit': '-30.8', 'ciUpperLimit': '12.9', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Overall flushing events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7', 'ciLowerLimit': '-14.1', 'ciUpperLimit': '27.8', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Overall flushing events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9', 'ciLowerLimit': '-30.8', 'ciUpperLimit': '12.9', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Overall redness events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4', 'ciLowerLimit': '-16.4', 'ciUpperLimit': '25.5', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Overall redness events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21', 'ciLowerLimit': '-41.7', 'ciUpperLimit': '1.3', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Overall tingling events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3', 'ciLowerLimit': '-23.3', 'ciUpperLimit': '18.7', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Overall tingling events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14', 'ciLowerLimit': '-35.2', 'ciUpperLimit': '8.3', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Overall itching events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12', 'ciLowerLimit': '-9.5', 'ciUpperLimit': '32.2', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Overall itching events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9', 'ciLowerLimit': '-30.8', 'ciUpperLimit': '12.9', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Overall warmth events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5', 'ciLowerLimit': '-16.4', 'ciUpperLimit': '25.5', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Overall warmth events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Week 8', 'description': 'Participant-reported flushing side effect events during the treatment period recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 (Combined), as Assessed by MFSS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG001', 'title': 'BG00012', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG002', 'title': 'BG00012 + ASA', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.'}, {'id': 'OG003', 'title': 'BG00012 Slow Titration', 'description': 'Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.'}], 'classes': [{'title': 'Overall flushing events', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}]}]}, {'title': 'Overall redness events', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '88', 'groupId': 'OG003'}]}]}, {'title': 'Overall warmth events', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '95', 'groupId': 'OG003'}]}]}, {'title': 'Overall tingling events', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '83', 'groupId': 'OG003'}]}]}, {'title': 'Overall itching events', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '95', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14', 'ciLowerLimit': '-35.2', 'ciUpperLimit': '8.3', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Overall flushing events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12', 'ciLowerLimit': '-9.5', 'ciUpperLimit': '32.2', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Overall flushing events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19', 'ciLowerLimit': '-39.6', 'ciUpperLimit': '3.7', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Redness events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7', 'ciLowerLimit': '-14.1', 'ciUpperLimit': '27.8', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Redness events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21', 'ciLowerLimit': '-41.7', 'ciUpperLimit': '1.3', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Warmth events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7', 'ciLowerLimit': '-14.1', 'ciUpperLimit': '27.8', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Warmth events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-33', 'ciLowerLimit': '-52.2', 'ciUpperLimit': '-10.6', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Tingling events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0', 'ciLowerLimit': '-21.0', 'ciUpperLimit': '21.0', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Tingling events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21', 'ciLowerLimit': '-41.7', 'ciUpperLimit': '1.3', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Itching events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '38.8', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Itching events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 1 to Week 4', 'description': 'Participant-reported flushing side effect events during Weeks 1 to 4 recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 (Combined), as Assessed by MFSS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG001', 'title': 'BG00012', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG002', 'title': 'BG00012 + ASA', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.'}, {'id': 'OG003', 'title': 'BG00012 Slow Titration', 'description': 'Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.'}], 'classes': [{'title': 'Overall flushing events', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}]}]}, {'title': 'Overall redness events', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}]}]}, {'title': 'Overall warmth events', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}]}]}, {'title': 'Overall tingling events', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}]}]}, {'title': 'Overall itching events', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14', 'ciLowerLimit': '-35.6', 'ciUpperLimit': '9.2', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Overall flushing events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2', 'ciLowerLimit': '-24.7', 'ciUpperLimit': '21.7', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Overall flushing events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14', 'ciLowerLimit': '-35.6', 'ciUpperLimit': '9.2', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Redness events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-22.9', 'ciUpperLimit': '23.7', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Redness events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11', 'ciLowerLimit': '-33.0', 'ciUpperLimit': '11.9', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Warmth events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5', 'ciLowerLimit': '-27.5', 'ciUpperLimit': '18.8', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Warmth events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-17', 'ciLowerLimit': '-38.1', 'ciUpperLimit': '6.5', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Tingling events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11', 'ciLowerLimit': '-34.2', 'ciUpperLimit': '12.2', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Tingling events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-20', 'ciLowerLimit': '-40.6', 'ciUpperLimit': '3.8', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Itching events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-18', 'ciLowerLimit': '-40.2', 'ciUpperLimit': '5.5', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Itching events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 5 to Week 8', 'description': 'Participant-reported flushing side effect events during Weeks 1 to 4 recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.'}, {'type': 'PRIMARY', 'title': 'Worst Severity Scores of Overall Flushing During Weeks 1 to 4 of Treatment (Combined), as Assessed by MFSS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG001', 'title': 'BG00012', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG002', 'title': 'BG00012 + ASA', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.'}, {'id': 'OG003', 'title': 'BG00012 Slow Titration', 'description': 'Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.'}], 'classes': [{'title': 'Overall flushing', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.70', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '2.68', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '2.26', 'groupId': 'OG002'}, {'value': '5.6', 'spread': '2.24', 'groupId': 'OG003'}]}]}, {'title': 'Redness', 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.33', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '2.76', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '1.75', 'groupId': 'OG002'}, {'value': '5.1', 'spread': '2.93', 'groupId': 'OG003'}]}]}, {'title': 'Warmth', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.76', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '2.55', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '2.17', 'groupId': 'OG002'}, {'value': '5.2', 'spread': '2.37', 'groupId': 'OG003'}]}]}, {'title': 'Tingling', 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '2.21', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '2.13', 'groupId': 'OG002'}, {'value': '4.0', 'spread': '2.62', 'groupId': 'OG003'}]}]}, {'title': 'Itching', 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '2.45', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '1.72', 'groupId': 'OG002'}, {'value': '4.3', 'spread': '2.10', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.9', 'ciLowerLimit': '-3.0', 'ciUpperLimit': '-0.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.53', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Overall flushing events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '0.2', 'ciUpperLimit': '2.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.54', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Overall flushing events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.2', 'ciLowerLimit': '-3.2', 'ciUpperLimit': '-1.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.50', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Redness events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '0.1', 'ciUpperLimit': '2.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.62', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Redness events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.7', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '-0.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.51', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Warmth events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '0.1', 'ciUpperLimit': '2.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.53', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Warmth events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.8', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '-0.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.47', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Tingling events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '1.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.52', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Tingling events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.9', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '-1.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.46', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Itching events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '0.2', 'ciUpperLimit': '2.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.50', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Itching events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 to Week 4', 'description': 'Worst severity of participant-reported flushing events during Weeks 1-4 of treatment combined, recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.'}, {'type': 'PRIMARY', 'title': 'Worst Severity Scores of Overall Flushing During Weeks 5 to 8 of Treatment (Combined), as Assessed by MFSS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG001', 'title': 'BG00012', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG002', 'title': 'BG00012 + ASA', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.'}, {'id': 'OG003', 'title': 'BG00012 Slow Titration', 'description': 'Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.'}], 'classes': [{'title': 'Overall flushing', 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.67', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '2.48', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '2.78', 'groupId': 'OG002'}, {'value': '3.1', 'spread': '2.26', 'groupId': 'OG003'}]}]}, {'title': 'Redness', 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '2.73', 'groupId': 'OG001'}, {'value': '2.9', 'spread': '2.67', 'groupId': 'OG002'}, {'value': '2.9', 'spread': '2.30', 'groupId': 'OG003'}]}]}, {'title': 'Warmth', 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.79', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '2.53', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '2.50', 'groupId': 'OG002'}, {'value': '2.9', 'spread': '2.15', 'groupId': 'OG003'}]}]}, {'title': 'Tingling', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '2.50', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '2.36', 'groupId': 'OG002'}, {'value': '2.2', 'spread': '1.96', 'groupId': 'OG003'}]}]}, {'title': 'Itching', 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.58', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '2.71', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '2.52', 'groupId': 'OG002'}, {'value': '1.8', 'spread': '2.04', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '0.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.62', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Overall flushing events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.57', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Overall flushing events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '0.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.63', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Redness events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.9', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.61', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Redness events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.59', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Warmth events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.56', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Warmth events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.57', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Tingling events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '-0.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.54', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Tingling events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.61', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Itching events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '-0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.58', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Itching events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Week 5 to Week 8', 'description': 'Worst severity of participant-reported flushing events during Weeks 1-4 of treatment combined, recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin.This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Global Flushing Severity Scale (MGFSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG001', 'title': 'BG00012', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG002', 'title': 'BG00012 + ASA', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.'}, {'id': 'OG003', 'title': 'BG00012 Slow Titration', 'description': 'Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12', 'ciLowerLimit': '-32.2', 'ciUpperLimit': '9.5', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Overall flushing events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7', 'ciLowerLimit': '-14.1', 'ciUpperLimit': '27.8', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Overall flushing events', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 2 to Week 8', 'description': 'Participant-reported flushing events during the overall treatment period, recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to events reported in the 24 hours after the first dose on Day 1.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MGFSS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG001', 'title': 'BG00012', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG002', 'title': 'BG00012 + ASA', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.'}, {'id': 'OG003', 'title': 'BG00012 Slow Titration', 'description': 'Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-22', 'ciLowerLimit': '-41.0', 'ciUpperLimit': '0.1', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7', 'ciLowerLimit': '-14.1', 'ciUpperLimit': '27.8', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 2 to Week 4', 'description': 'Participant-reported flushing events during Weeks 1 to 4 of treatment (combined), recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to events reported in the 24 hours after the first dose on Day 1.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MGFSS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG001', 'title': 'BG00012', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG002', 'title': 'BG00012 + ASA', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.'}, {'id': 'OG003', 'title': 'BG00012 Slow Titration', 'description': 'Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-20', 'ciLowerLimit': '-40.6', 'ciUpperLimit': '3.8', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2', 'ciLowerLimit': '-24.7', 'ciUpperLimit': '21.7', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 5 to Week 8', 'description': 'Participant-reported flushing events during Weeks 5 to 8 of treatment (combined), recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to last 24 hours flushing score.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting Gastrointestinal (GI) Events During the Overall Treatment Period, as Assessed by the Modified Acute Gastrointestinal Scale (MAGISS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG001', 'title': 'BG00012', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG002', 'title': 'BG00012 + ASA', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.'}, {'id': 'OG003', 'title': 'BG00012 Slow Titration', 'description': 'Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '86', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-22.0', 'ciUpperLimit': '22.0', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4', 'ciLowerLimit': '-16.4', 'ciUpperLimit': '25.5', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Week 8', 'description': 'The MAGISS is a participant-reported questionnaire about side effects of the gastrointestinal system following drug administration, and is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. A participant was considered having overall GI side effect if he/she had a score of \\>=1 for at least one of the GI side effects including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating and flatulence.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG001', 'title': 'BG00012', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG002', 'title': 'BG00012 + ASA', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.'}, {'id': 'OG003', 'title': 'BG00012 Slow Titration', 'description': 'Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2', 'ciLowerLimit': '-24.2', 'ciUpperLimit': '19.7', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3', 'ciLowerLimit': '-23.3', 'ciUpperLimit': '18.7', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Week 4', 'description': 'The MAGISS is a participant-reported questionnaire about side effects of the gastrointestinal system following drug administration, and is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. A participant was considered having overall GI side effect if he/she had a score of \\>=1 for at least one of the GI side effects including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating and flatulence.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG001', 'title': 'BG00012', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG002', 'title': 'BG00012 + ASA', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.'}, {'id': 'OG003', 'title': 'BG00012 Slow Titration', 'description': 'Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7', 'ciLowerLimit': '-29.4', 'ciUpperLimit': '17.1', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1', 'ciLowerLimit': '-22.1', 'ciUpperLimit': '24.5', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 5 to Week 8', 'description': 'The MAGISS is a participant-reported questionnaire about side effects of the gastrointestinal system following drug administration, and is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. A participant was considered having overall GI side effect if he/she had a score of \\>=1 for at least one of the GI side effects including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating and flatulence.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.'}, {'type': 'PRIMARY', 'title': 'Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG001', 'title': 'BG00012', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG002', 'title': 'BG00012 + ASA', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.'}, {'id': 'OG003', 'title': 'BG00012 Slow Titration', 'description': 'Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.'}], 'classes': [{'title': 'Nausea', 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.59', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '2.41', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '2.54', 'groupId': 'OG002'}, {'value': '1.5', 'spread': '2.09', 'groupId': 'OG003'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.97', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '2.47', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '2.76', 'groupId': 'OG002'}, {'value': '1.0', 'spread': '1.67', 'groupId': 'OG003'}]}]}, {'title': 'Upper abdominal pain', 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '2.16', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '2.71', 'groupId': 'OG002'}, {'value': '1.4', 'spread': '2.47', 'groupId': 'OG003'}]}]}, {'title': 'Lower abdominal pain', 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '2.14', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '2.32', 'groupId': 'OG002'}, {'value': '1.2', 'spread': '2.12', 'groupId': 'OG003'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.28', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '1.63', 'groupId': 'OG002'}, {'value': '0.2', 'spread': '1.10', 'groupId': 'OG003'}]}]}, {'title': 'Indigestion', 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '1.83', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '1.26', 'groupId': 'OG002'}, {'value': '0.9', 'spread': '1.97', 'groupId': 'OG003'}]}]}, {'title': 'Constipation', 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '2.23', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '1.45', 'groupId': 'OG002'}, {'value': '0.9', 'spread': '1.85', 'groupId': 'OG003'}]}]}, {'title': 'Bloating', 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.17', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.96', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '2.08', 'groupId': 'OG002'}, {'value': '1.0', 'spread': '1.88', 'groupId': 'OG003'}]}]}, {'title': 'Flatulence', 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '2.03', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '1.76', 'groupId': 'OG002'}, {'value': '1.6', 'spread': '2.20', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '1.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.53', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Nausea', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '0.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.49', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Nausea', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '0.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.57', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Diarrhea', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.46', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Diarrhea', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '1.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.53', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Upper abdominal pain', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '1.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.50', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Upper abdominal pain', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.48', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Lower abdominal pain', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '0.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.46', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Lower abdominal pain', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.32', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Vomiting', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.26', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Vomiting', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.34', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Indigestion', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '0.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.41', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Indigestion', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.41', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Constipation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '0.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.44', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Constipation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '1.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.4', 'groupDescription': 'Bloating', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '0.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.42', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Bloating', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '0.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.41', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Flatulence', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '1.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.46', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Flatulence', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 to Week 4', 'description': 'Severity of GI-related events using the MAGISS to measure GI symptoms (nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, flatulence), based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.'}, {'type': 'PRIMARY', 'title': 'Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG001', 'title': 'BG00012', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG002', 'title': 'BG00012 + ASA', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.'}, {'id': 'OG003', 'title': 'BG00012 Slow Titration', 'description': 'Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.'}], 'classes': [{'title': 'Nausea', 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.51', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '1.79', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '1.94', 'groupId': 'OG002'}, {'value': '0.9', 'spread': '1.65', 'groupId': 'OG003'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '1.0', 'spread': '2.01', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '2.29', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '2.13', 'groupId': 'OG002'}, {'value': '0.7', 'spread': '1.42', 'groupId': 'OG003'}]}]}, {'title': 'Upper abdominal pain', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.69', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.50', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '1.21', 'groupId': 'OG002'}, {'value': '0.6', 'spread': '1.56', 'groupId': 'OG003'}]}]}, {'title': 'Lower abdominal pain', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.48', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.42', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '1.38', 'groupId': 'OG002'}, {'value': '0.9', 'spread': '1.72', 'groupId': 'OG003'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '0.2', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.82', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0.83', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG003'}]}]}, {'title': 'Indigestion', 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.32', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '1.38', 'groupId': 'OG002'}, {'value': '0.4', 'spread': '1.06', 'groupId': 'OG003'}]}]}, {'title': 'Constipation', 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.59', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '1.63', 'groupId': 'OG002'}, {'value': '0.3', 'spread': '1.05', 'groupId': 'OG003'}]}]}, {'title': 'Bloating', 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.61', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '1.55', 'groupId': 'OG002'}, {'value': '0.8', 'spread': '1.52', 'groupId': 'OG003'}]}]}, {'title': 'Flatulence', 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.65', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '2.04', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '1.08', 'groupId': 'OG002'}, {'value': '0.9', 'spread': '1.54', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.44', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Nausea', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '0.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.41', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Nausea', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.52', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Diarrhea', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.46', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Diarrhea', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '0.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.32', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Upper abdominal pain', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '0.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.37', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Upper abdominal pain', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.33', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Lower abdominal pain', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '1.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.38', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Lower abdominal pain', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.19', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Vomiting', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Vomiting', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.32', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Indigestion', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.29', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Indigestion', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '1.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.28', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Constipation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.20', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Constipation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '0.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.37', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Bloating', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '0.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.38', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Bloating', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '-0.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.38', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Flatulence', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.44', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Flatulence', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Week 5 to Week 8', 'description': 'Severity of GI-related events using the MAGISS to measure GI symptoms (nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, flatulence), based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting GI Events During the Overall Treatment Period, as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG001', 'title': 'BG00012', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG002', 'title': 'BG00012 + ASA', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.'}, {'id': 'OG003', 'title': 'BG00012 Slow Titration', 'description': 'Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9', 'ciLowerLimit': '-11.8', 'ciUpperLimit': '30.0', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9', 'ciLowerLimit': '-11.8', 'ciUpperLimit': '30.0', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Week 8', 'description': 'The MOGISS is a questionnaire about overall side effects related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. Participants were to answer the questions at the same time each day, before the morning drug administration.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting GI Events During Weeks 1 to 4 (Combined), as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG001', 'title': 'BG00012', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG002', 'title': 'BG00012 + ASA', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.'}, {'id': 'OG003', 'title': 'BG00012 Slow Titration', 'description': 'Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2', 'ciLowerLimit': '-18.8', 'ciUpperLimit': '23.3', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6', 'ciLowerLimit': '-14.1', 'ciUpperLimit': '27.8', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 1 to Week 4', 'description': 'The MOGISS is a questionnaire about overall side effects related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. Participants were to answer the questions at the same time each day, before the morning drug administration.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting GI Events During Weeks 5 to 8 (Combined), as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG001', 'title': 'BG00012', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG002', 'title': 'BG00012 + ASA', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.'}, {'id': 'OG003', 'title': 'BG00012 Slow Titration', 'description': 'Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9', 'ciLowerLimit': '-32.1', 'ciUpperLimit': '14.3', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2', 'ciLowerLimit': '-25.0', 'ciUpperLimit': '21.7', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 5 to Week 8', 'description': 'The MOGISS is a questionnaire about overall side effects related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. Participants were to answer the questions at the same time each day, before the morning drug administration.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG001', 'title': 'BG00012', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG002', 'title': 'BG00012 + ASA', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.'}, {'id': 'OG003', 'title': 'BG00012 Slow Titration', 'description': 'Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.'}], 'classes': [{'title': 'Any event', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}]}, {'title': 'Moderate or severe event', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}, {'title': 'Severe event', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Related event', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}]}, {'title': 'Serious event', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Discontinuation of treatment due to an event', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Withdrawal from study due to an event', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to end of Safety Follow-up (9 weeks)', 'description': 'AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes. An AE was considered treatment-emergent if it occurred after the start of study treatment or was present prior to the start of study treatment but subsequently worsened.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo).'}, {'type': 'SECONDARY', 'title': 'Clinical Laboratory Shifts From Baseline in Reported Values: Hematology', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG001', 'title': 'BG00012', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG002', 'title': 'BG00012 + ASA', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.'}, {'id': 'OG003', 'title': 'BG00012 Slow Titration', 'description': 'Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.'}], 'classes': [{'title': 'White blood cells: shift to low; n=43, 43, 43, 41', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'White blood cells: shift to high; n=44, 43, 43, 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Neutrophils abs: shift to low; n=42, 42, 42, 41', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Neutrophils abs: shift to high; n=44, 43, 43, 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Lymphocytes abs: shift to low; n=43, 43, 43, 41', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Lymphocytes abs: shift to high; n=44, 43, 42, 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Monocytes abs: shift to low; n=44, 43, 43, 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Monocytes abs: shift to high; n=44, 43, 43, 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Eosinophils abs: shift to low; n=44, 43, 43, 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Eosinophils abs: shift to high; n=44, 43, 43, 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Basophils abs: shift to high; n=44, 43, 43, 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Red blood cells: shift to low; n=44, 43, 43, 40', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Red blood cells: shift to high; n=44, 43, 43, 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hemoglobin: shift to low; n=43, 41, 43, 42', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hemoglobin: shift to high; n=44, 43, 43, 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hematocrit: shift to low; n=44, 43, 43, 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hematocrit: shift to high; n=43, 43, 43, 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Platelets: shift to low; n=44, 43, 43, 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Platelets: shift to high; n=44, 41, 43, 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Week 8', 'description': 'Number of participants with clinical laboratory shifts from baseline in hematology values. Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. abs=absolute', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo); n=number of participants whose baseline value was not low (or high) and who had at least 1 post-baseline value.'}, {'type': 'SECONDARY', 'title': 'Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG001', 'title': 'BG00012', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG002', 'title': 'BG00012 + ASA', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.'}, {'id': 'OG003', 'title': 'BG00012 Slow Titration', 'description': 'Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.'}], 'classes': [{'title': 'ALP: shift to high; n=44, 42, 43, 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'ALT: shift to high; n=44, 42, 43, 42', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'AST: shift to high; n=44, 43, 43, 41', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'GGT: shift to high; n=44, 41, 43, 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'LDH: shift to low; n=44, 43, 43, 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'LDH: shift to high; n=44, 43, 43, 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total bilirubin: shift to high; n=44, 42, 42, 40', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'BUN: shift to low; n=44, 43, 43, 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'BUN: shift to high; n=44, 43, 41, 42', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Creatinine: shift to low; n=44, 43, 43, 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Creatinine: shift to high; n=44, 43, 43, 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Uric Acid: shift to low; n=44, 43, 43, 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Uric Acid: shift to high; n=44, 43, 43, 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Sodium: shift to low; n=44, 43, 43, 42', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Sodium: shift to high; n=44, 43, 43, 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Potassium: shift to low: n=44, 43, 43, 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Potassium: shift to high: n=44, 42, 42, 41', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Chloride: shift to low; n=44, 43, 43, 42', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Chloride: shift to high; n=44, 43, 43, 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Bicarbonate: shift to low; n=44, 43, 43, 42', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Bicarbonate: shift to high; n=44, 43, 43, 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Calcium: shift to low; n=44, 42, 43, 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Calcium: shift to high; n=44, 43, 43, 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Glucose: shift to low; n=43, 43, 41, 41', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Glucose: shift to high; n=44, 43, 43, 42', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Magnesium: shift to low; n=44, 43, 43, 42', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Magnesium: shift to high; n=44, 43, 43, 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Phosphorus: shift to low; n=44, 43, 43, 41', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Phosphorus: shift to high; n=44, 43, 43, 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Albumin: shift to low; n=44, 43, 43, 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Albumin: shift to high; n=44, 43, 43, 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Direct bilirubin: shift to high; n=44, 43, 43, 40', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total protein: shift to low; n=44, 41, 43, 41', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total protein: shift to high; n=44, 43, 43, 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Week 8', 'description': 'Number of participants with clinical laboratory shifts from baseline in blood chemistry values. Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. ALP=alkaline phosphatase, ALT=alanine aminotransferase, AST=aspartate aminotransferase, GGT=gamma-glutamyl transferase, LDH=lactate dehydrogenase, BUN=blood urea nitrogen.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo); n=number of participants whose baseline value was not low (or high) and who had at least 1 post-baseline value.'}, {'type': 'SECONDARY', 'title': 'Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG001', 'title': 'BG00012', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG002', 'title': 'BG00012 + ASA', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.'}, {'id': 'OG003', 'title': 'BG00012 Slow Titration', 'description': 'Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.'}], 'classes': [{'title': 'Specific gravity: shift to low; n=44, 43, 43, 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Specific gravity: shift to high; n=44, 42, 43, 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'pH: shift to low; n=44, 43, 43, 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'pH: shift to high; n=44, 43, 43, 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Blood: shift to positive; n=42, 39, 39, 42', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Color: shift to positive; n=41, 43, 41, 39', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Glucose: shift to positive; n=44, 43, 43, 41', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Ketones: shift to positive; n=44, 43, 43, 42', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Protein: shift to positive; n=44, 41, 43, 41', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Microscopic RBC; n=44, 40, 40, 41', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Microscopic WBC; n=43, 40, 41, 42', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Week 8', 'description': 'Number of participants with clinical laboratory shifts from baseline in urinalysis values.Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. Shift to positive includes negative to positive and unknown to positive. RBC=red blood cells, WBC=white blood cells.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo); n=number of participants whose baseline value was not low (or high or positive) and who had at least 1 post-baseline value.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormalities in Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG001', 'title': 'BG00012', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG002', 'title': 'BG00012 + ASA', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.'}, {'id': 'OG003', 'title': 'BG00012 Slow Titration', 'description': 'Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.'}], 'classes': [{'title': 'Temperature >38°C + ↑ from BL of ≥1°C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Pulse >120 bpm or ↑ from BL of >20 bpm', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}]}, {'title': 'Pulse <50 bpm or ↓ from BL of >20 bpm', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'SBP >180 mm Hg or ↑ from BL of >40 mm Hg', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'SBP <90 mm Hg or ↓ from BL of >30 mm Hg', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'DBP >105 mm Hg or ↑ from BL of >30 mm Hg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'DBP <50 mm Hg or ↓ from BL of >20 mm Hg', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Respiration rate >25 b/m or ↑ from BL of ≥50%', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Respiration rate 10 b/m or ↓ from BL of ≥50%', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Week 8', 'description': '↑=increase; ↓=decrease; BL=baseline; bpm=beats per minute; SBP=systolic blood pressure; DBP=diastolic blood pressure; b/m=breaths per minute', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo); n=number of participants who had a baseline value and had at least 1 post-baseline value.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Shifts From Baseline in Electrocardiogram (ECG) Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG001', 'title': 'BG00012', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG002', 'title': 'BG00012 + ASA', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.'}, {'id': 'OG003', 'title': 'BG00012 Slow Titration', 'description': 'Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.'}], 'classes': [{'title': 'Shift to abnormal, not adverse event', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Shift to abnormal, adverse event', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Week 8', 'description': "Shift to 'abnormal, not adverse event' includes unknown or normal to 'abnormal, not adverse event.' Shift to 'abnormal, adverse event' includes unknown or normal to 'abnormal, adverse event.'", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo); n=number of participants whose baseline value was not abnormal and who had at least 1 post-baseline value.'}, {'type': 'SECONDARY', 'title': 'Duration of Flushing Events During the Overall Treatment Period, Based on MFSS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG001', 'title': 'BG00012', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG002', 'title': 'BG00012 + ASA', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.'}, {'id': 'OG003', 'title': 'BG00012 Slow Titration', 'description': 'Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.4', 'spread': '92.04', 'groupId': 'OG000'}, {'value': '63.2', 'spread': '34.55', 'groupId': 'OG001'}, {'value': '69.8', 'spread': '78.09', 'groupId': 'OG002'}, {'value': '68.9', 'spread': '52.82', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.6', 'ciLowerLimit': '-20.9', 'ciUpperLimit': '34.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.79', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.8', 'ciLowerLimit': '-14.2', 'ciUpperLimit': '25.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.03', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 to Week 8', 'description': 'For participants with more than 1 flushing episode during a visit interval, the average duration for the visit interval was used. The average duration is calculated as: the total duration of all flushing episodes / the total number of flushing episodes.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with a flushing event.'}, {'type': 'SECONDARY', 'title': 'Duration of Flushing Events During the Weeks 1 to 4 (Combined), Based on MFSS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG001', 'title': 'BG00012', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG002', 'title': 'BG00012 + ASA', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.'}, {'id': 'OG003', 'title': 'BG00012 Slow Titration', 'description': 'Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '117.6', 'spread': '143.90', 'groupId': 'OG000'}, {'value': '67.6', 'spread': '43.83', 'groupId': 'OG001'}, {'value': '89.8', 'spread': '140.67', 'groupId': 'OG002'}, {'value': '69.2', 'spread': '53.00', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.2', 'ciLowerLimit': '-26.5', 'ciUpperLimit': '70.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '24.40', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.6', 'ciLowerLimit': '-20.5', 'ciUpperLimit': '23.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.08', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Week 1 to Week 4', 'description': 'For participants with more than 1 flushing episode during a visit interval, the average duration for the visit interval was used. The average duration is calculated as: the total duration of all flushing episodes / the total number of flushing episodes.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with a flushing event.'}, {'type': 'SECONDARY', 'title': 'Duration of Flushing Events During the Weeks 5 to 8 (Combined), Based on MFSS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG001', 'title': 'BG00012', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG002', 'title': 'BG00012 + ASA', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.'}, {'id': 'OG003', 'title': 'BG00012 Slow Titration', 'description': 'Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '113.2', 'spread': '160.82', 'groupId': 'OG000'}, {'value': '55.7', 'spread': '32.37', 'groupId': 'OG001'}, {'value': '73.2', 'spread': '66.34', 'groupId': 'OG002'}, {'value': '56.0', 'spread': '35.79', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.5', 'ciLowerLimit': '-9.2', 'ciUpperLimit': '44.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.32', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-17.2', 'ciUpperLimit': '18.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.80', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Week 5 to Week 8', 'description': 'For participants with more than 1 flushing episode during a visit interval, the average duration for the visit interval was used. The average duration is calculated as: the total duration of all flushing episodes / the total number of flushing episodes.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with a flushing event.'}, {'type': 'SECONDARY', 'title': 'Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG001', 'title': 'BG00012', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG002', 'title': 'BG00012 + ASA', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.'}, {'id': 'OG003', 'title': 'BG00012 Slow Titration', 'description': 'Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.'}], 'classes': [{'title': 'Nausea; n=12, 21, 21, 22', 'categories': [{'measurements': [{'value': '9.74', 'spread': '17.008', 'groupId': 'OG000'}, {'value': '7.05', 'spread': '10.498', 'groupId': 'OG001'}, {'value': '10.01', 'spread': '18.283', 'groupId': 'OG002'}, {'value': '2.98', 'spread': '3.247', 'groupId': 'OG003'}]}]}, {'title': 'Diarrhea; n=20, 20 17, 15', 'categories': [{'measurements': [{'value': '5.57', 'spread': '10.037', 'groupId': 'OG000'}, {'value': '2.92', 'spread': '3.329', 'groupId': 'OG001'}, {'value': '14.66', 'spread': '32.686', 'groupId': 'OG002'}, {'value': '4.97', 'spread': '9.687', 'groupId': 'OG003'}]}]}, {'title': 'Upper abdominal pain; n=17, 14, 19, 19', 'categories': [{'measurements': [{'value': '19.08', 'spread': '46.873', 'groupId': 'OG000'}, {'value': '6.67', 'spread': '16.916', 'groupId': 'OG001'}, {'value': '15.88', 'spread': '25.307', 'groupId': 'OG002'}, {'value': '3.83', 'spread': '5.712', 'groupId': 'OG003'}]}]}, {'title': 'Lower abdominal pain; n=12, 19, 17, 16', 'categories': [{'measurements': [{'value': '6.65', 'spread': '5.307', 'groupId': 'OG000'}, {'value': '13.93', 'spread': '26.850', 'groupId': 'OG001'}, {'value': '10.84', 'spread': '16.312', 'groupId': 'OG002'}, {'value': '7.75', 'spread': '10.456', 'groupId': 'OG003'}]}]}, {'title': 'Vomiting; n=3, 3, 3, 2', 'categories': [{'measurements': [{'value': '5.87', 'spread': '5.033', 'groupId': 'OG000'}, {'value': '10.08', 'spread': '8.755', 'groupId': 'OG001'}, {'value': '1.88', 'spread': '2.717', 'groupId': 'OG002'}, {'value': '0.75', 'spread': '0.707', 'groupId': 'OG003'}]}]}, {'title': 'Indigestion; n=12, 13, 12, 12', 'categories': [{'measurements': [{'value': '4.76', 'spread': '8.203', 'groupId': 'OG000'}, {'value': '16.49', 'spread': '28.865', 'groupId': 'OG001'}, {'value': '3.80', 'spread': '2.543', 'groupId': 'OG002'}, {'value': '4.91', 'spread': '8.263', 'groupId': 'OG003'}]}]}, {'title': 'Constipation; n=6, 8, 13, 11', 'categories': [{'measurements': [{'value': '20.49', 'spread': '12.040', 'groupId': 'OG000'}, {'value': '28.20', 'spread': '35.425', 'groupId': 'OG001'}, {'value': '14.26', 'spread': '9.783', 'groupId': 'OG002'}, {'value': '20.90', 'spread': '18.060', 'groupId': 'OG003'}]}]}, {'title': 'Bloating; n=14, 14, 21, 12', 'categories': [{'measurements': [{'value': '9.50', 'spread': '9.066', 'groupId': 'OG000'}, {'value': '16.91', 'spread': '27.128', 'groupId': 'OG001'}, {'value': '9.68', 'spread': '10.108', 'groupId': 'OG002'}, {'value': '77.24', 'spread': '125.961', 'groupId': 'OG003'}]}]}, {'title': 'Flatulence; n=23, 20, 22, 20', 'categories': [{'measurements': [{'value': '16.41', 'spread': '44.149', 'groupId': 'OG000'}, {'value': '9.06', 'spread': '9.626', 'groupId': 'OG001'}, {'value': '68.93', 'spread': '290.248', 'groupId': 'OG002'}, {'value': '63.84', 'spread': '180.597', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.96', 'ciLowerLimit': '-6.34', 'ciUpperLimit': '12.26', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.601', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Nausea', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.07', 'ciLowerLimit': '-8.81', 'ciUpperLimit': '0.67', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.347', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Nausea', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.74', 'ciLowerLimit': '-3.15', 'ciUpperLimit': '26.63', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.335', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Diarrhea', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.05', 'ciLowerLimit': '-2.67', 'ciUpperLimit': '6.77', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.321', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Diarrhea', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.21', 'ciLowerLimit': '-6.72', 'ciUpperLimit': '25.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.812', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Upper abdominal pain', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.84', 'ciLowerLimit': '-11.31', 'ciUpperLimit': '5.63', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.152', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Upper abdominal pain', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.09', 'ciLowerLimit': '-18.36', 'ciUpperLimit': '12.19', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.516', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Lower abdominal pain', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.18', 'ciLowerLimit': '-20.71', 'ciUpperLimit': '8.35', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.141', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Lower abdominal pain', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.21', 'ciLowerLimit': '-22.90', 'ciUpperLimit': '6.49', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.292', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Vomiting', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.33', 'ciLowerLimit': '-30.13', 'ciUpperLimit': '11.47', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.536', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Vomiting', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.69', 'ciLowerLimit': '-30.02', 'ciUpperLimit': '4.63', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.376', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Indigestion', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.58', 'ciLowerLimit': '-29.48', 'ciUpperLimit': '6.32', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.654', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Indigestion', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.93', 'ciLowerLimit': '-35.44', 'ciUpperLimit': '7.57', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.274', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Constipation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.29', 'ciLowerLimit': '-33.39', 'ciUpperLimit': '18.81', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.369', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Constipation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.24', 'ciLowerLimit': '-20.40', 'ciUpperLimit': '5.93', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.472', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Bloating', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '60.33', 'ciLowerLimit': '-10.78', 'ciUpperLimit': '131.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '34.455', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Bloating', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '59.87', 'ciLowerLimit': '-71.51', 'ciUpperLimit': '191.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '65.007', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Flatulence', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '54.78', 'ciLowerLimit': '-27.09', 'ciUpperLimit': '136.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '40.440', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Flatulence', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 to Week 8', 'description': 'Duration is calculated as follows: \\[(GI side effect) end date/time - (GI side effect) start date/time\\]/3600. For GI side effects with no end date, the end date is imputed using the last diary date/time. For subjects with more than 1 GI episode during a visit interval, the average duration for the study visit interval is used. The average duration is calculated as the total duration of the GI side effect / the total number of GI side effects.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the safety population who have at least 1 diary entry of the relevant questionnaire data during the visit interval; n=number of participants with the given GI episode during the visit interval.'}, {'type': 'SECONDARY', 'title': 'Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG001', 'title': 'BG00012', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG002', 'title': 'BG00012 + ASA', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.'}, {'id': 'OG003', 'title': 'BG00012 Slow Titration', 'description': 'Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.'}], 'classes': [{'title': 'Nausea; n=10, 18, 18, 20', 'categories': [{'measurements': [{'value': '10.47', 'spread': '18.678', 'groupId': 'OG000'}, {'value': '7.23', 'spread': '10.916', 'groupId': 'OG001'}, {'value': '11.18', 'spread': '19.568', 'groupId': 'OG002'}, {'value': '2.86', 'spread': '3.359', 'groupId': 'OG003'}]}]}, {'title': 'Diarrhea; n=13, 20, 14, 14', 'categories': [{'measurements': [{'value': '5.20', 'spread': '11.309', 'groupId': 'OG000'}, {'value': '2.53', 'spread': '3.013', 'groupId': 'OG001'}, {'value': '16.04', 'spread': '35.945', 'groupId': 'OG002'}, {'value': '4.97', 'spread': '10.074', 'groupId': 'OG003'}]}]}, {'title': 'Upper abdominal pain; n=14, 14, 17, 15', 'categories': [{'measurements': [{'value': '21.37', 'spread': '51.620', 'groupId': 'OG000'}, {'value': '6.81', 'spread': '16.876', 'groupId': 'OG001'}, {'value': '17.65', 'spread': '26.294', 'groupId': 'OG002'}, {'value': '4.31', 'spread': '6.350', 'groupId': 'OG003'}]}]}, {'title': 'Lower abdominal pain; n=9, 18, 14, 13', 'categories': [{'measurements': [{'value': '5.40', 'spread': '4.658', 'groupId': 'OG000'}, {'value': '14.20', 'spread': '27.637', 'groupId': 'OG001'}, {'value': '12.51', 'spread': '17.621', 'groupId': 'OG002'}, {'value': '6.30', 'spread': '6.080', 'groupId': 'OG003'}]}]}, {'title': 'Vomiting; n=2, 2, 2, 2', 'categories': [{'measurements': [{'value': '4.31', 'spread': '5.999', 'groupId': 'OG000'}, {'value': '5.63', 'spread': '5.834', 'groupId': 'OG001'}, {'value': '2.53', 'spread': '3.500', 'groupId': 'OG002'}, {'value': '0.75', 'spread': '0.707', 'groupId': 'OG003'}]}]}, {'title': 'Indigestion; n=11, 11, 9, 11', 'categories': [{'measurements': [{'value': '5.08', 'spread': '8.552', 'groupId': 'OG000'}, {'value': '29.00', 'spread': '48.416', 'groupId': 'OG001'}, {'value': '3.93', 'spread': '2.873', 'groupId': 'OG002'}, {'value': '5.05', 'spread': '8.665', 'groupId': 'OG003'}]}]}, {'title': 'Constipation; n=4, 8, 11, 11', 'categories': [{'measurements': [{'value': '17.05', 'spread': '7.452', 'groupId': 'OG000'}, {'value': '27.61', 'spread': '35.177', 'groupId': 'OG001'}, {'value': '15.12', 'spread': '7.761', 'groupId': 'OG002'}, {'value': '21.28', 'spread': '19.298', 'groupId': 'OG003'}]}]}, {'title': 'Bloating; n=9, 14, 19, 11', 'categories': [{'measurements': [{'value': '6.70', 'spread': '6.792', 'groupId': 'OG000'}, {'value': '13.81', 'spread': '25.321', 'groupId': 'OG001'}, {'value': '11.07', 'spread': '10.631', 'groupId': 'OG002'}, {'value': '95.69', 'spread': '186.884', 'groupId': 'OG003'}]}]}, {'title': 'Flatulence; n=21, 17, 22, 19', 'categories': [{'measurements': [{'value': '12.83', 'spread': '27.948', 'groupId': 'OG000'}, {'value': '9.34', 'spread': '12.946', 'groupId': 'OG001'}, {'value': '35.86', 'spread': '134.748', 'groupId': 'OG002'}, {'value': '61.13', 'spread': '168.572', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.95', 'ciLowerLimit': '-6.79', 'ciUpperLimit': '14.68', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.281', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Nausea', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.37', 'ciLowerLimit': '-9.57', 'ciUpperLimit': '0.83', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.563', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Nausea', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.51', 'ciLowerLimit': '-2.84', 'ciUpperLimit': '29.86', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.024', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Diarrhea', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.44', 'ciLowerLimit': '-2.41', 'ciUpperLimit': '7.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.379', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Diarrhea', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.84', 'ciLowerLimit': '-5.81', 'ciUpperLimit': '27.50', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.143', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Upper abdominal pain', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.50', 'ciLowerLimit': '-12.08', 'ciUpperLimit': '7.09', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.671', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Upper abdominal pain', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.69', 'ciLowerLimit': '-19.03', 'ciUpperLimit': '15.64', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.488', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Lower abdominal pain', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.91', 'ciLowerLimit': '-23.93', 'ciUpperLimit': '8.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.832', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Lower abdominal pain', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.10', 'ciLowerLimit': '-23.80', 'ciUpperLimit': '17.60', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.811', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Vomiting', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.88', 'ciLowerLimit': '-22.75', 'ciUpperLimit': '13.00', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.155', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Vomiting', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-25.08', 'ciLowerLimit': '-59.20', 'ciUpperLimit': '9.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '16.243', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Indigestion', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-23.95', 'ciLowerLimit': '-54.89', 'ciUpperLimit': '6.98', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '14.830', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Indigestion', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.49', 'ciLowerLimit': '-35.38', 'ciUpperLimit': '10.39', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.847', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Constipation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.33', 'ciLowerLimit': '-32.79', 'ciUpperLimit': '20.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.542', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Constipation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.73', 'ciLowerLimit': '-15.87', 'ciUpperLimit': '10.41', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.442', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Bloating', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '81.89', 'ciLowerLimit': '-22.04', 'ciUpperLimit': '185.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '50.239', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Bloating', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.52', 'ciLowerLimit': '-40.13', 'ciUpperLimit': '93.18', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '32.896', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Flatulence', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '51.78', 'ciLowerLimit': '-31.65', 'ciUpperLimit': '135.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '41.055', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Flatulence', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Week 1 to Week 4', 'description': 'Duration is calculated as follows: \\[(GI side effect) end date/time - (GI side effect) start date/time\\]/3600. For GI side effects with no end date, the end date is imputed using the last diary date/time. For subjects with more than 1 GI episode during a visit interval, the average duration for the study visit interval is used. The average duration is calculated as the total duration of the GI side effect / the total number of GI side effects.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the safety population who have at least 1 diary entry of the relevant questionnaire data during the visit interval; n=number of participants with the given GI episode during the visit interval.'}, {'type': 'SECONDARY', 'title': 'Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG001', 'title': 'BG00012', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'OG002', 'title': 'BG00012 + ASA', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.'}, {'id': 'OG003', 'title': 'BG00012 Slow Titration', 'description': 'Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.'}], 'classes': [{'title': 'Nausea; n=4, 9, 6, 9', 'categories': [{'measurements': [{'value': '3.96', 'spread': '3.668', 'groupId': 'OG000'}, {'value': '4.34', 'spread': '6.256', 'groupId': 'OG001'}, {'value': '2.66', 'spread': '1.390', 'groupId': 'OG002'}, {'value': '2.34', 'spread': '1.904', 'groupId': 'OG003'}]}]}, {'title': 'Diarrhea; n=12, 13, 6, 8', 'categories': [{'measurements': [{'value': '4.50', 'spread': '6.389', 'groupId': 'OG000'}, {'value': '6.62', 'spread': '12.782', 'groupId': 'OG001'}, {'value': '7.05', 'spread': '8.002', 'groupId': 'OG002'}, {'value': '2.14', 'spread': '2.007', 'groupId': 'OG003'}]}]}, {'title': 'Upper abdominal pain; n=6, 5, 5, 5', 'categories': [{'measurements': [{'value': '5.29', 'spread': '5.785', 'groupId': 'OG000'}, {'value': '1.12', 'spread': '0.965', 'groupId': 'OG001'}, {'value': '1.86', 'spread': '1.491', 'groupId': 'OG002'}, {'value': '1.73', 'spread': '1.440', 'groupId': 'OG003'}]}]}, {'title': 'Lower abdominal pain; n=7, 5, 5, 9', 'categories': [{'measurements': [{'value': '6.63', 'spread': '7.739', 'groupId': 'OG000'}, {'value': '3.98', 'spread': '3.516', 'groupId': 'OG001'}, {'value': '2.84', 'spread': '1.477', 'groupId': 'OG002'}, {'value': '22.54', 'spread': '61.180', 'groupId': 'OG003'}]}]}, {'title': 'Vomiting; n=1, 1, 1, 0', 'categories': [{'measurements': [{'value': '9.00', 'spread': 'NA', 'comment': 'n=1 participant', 'groupId': 'OG000'}, {'value': '19.00', 'spread': 'NA', 'comment': 'n=1 participant', 'groupId': 'OG001'}, {'value': '0.58', 'spread': 'NA', 'comment': 'n=1 participant', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'n=0 participants', 'groupId': 'OG003'}]}]}, {'title': 'Indigestion; n=6, 7, 7, 5', 'categories': [{'measurements': [{'value': '2.43', 'spread': '1.569', 'groupId': 'OG000'}, {'value': '2.57', 'spread': '2.586', 'groupId': 'OG001'}, {'value': '5.02', 'spread': '6.944', 'groupId': 'OG002'}, {'value': '1.63', 'spread': '1.101', 'groupId': 'OG003'}]}]}, {'title': 'Constipation; n=5, 2, 4, 4', 'categories': [{'measurements': [{'value': '23.35', 'spread': '17.110', 'groupId': 'OG000'}, {'value': '15.47', 'spread': '21.143', 'groupId': 'OG001'}, {'value': '21.30', 'spread': '23.181', 'groupId': 'OG002'}, {'value': '18.24', 'spread': '8.644', 'groupId': 'OG003'}]}]}, {'title': 'Bloating; n=7, 8, 7, 8', 'categories': [{'measurements': [{'value': '12.49', 'spread': '10.595', 'groupId': 'OG000'}, {'value': '18.52', 'spread': '25.682', 'groupId': 'OG001'}, {'value': '4.16', 'spread': '3.018', 'groupId': 'OG002'}, {'value': '85.64', 'spread': '115.872', 'groupId': 'OG003'}]}]}, {'title': 'Flatulence; n=9, 13, 7, 10', 'categories': [{'measurements': [{'value': '44.67', 'spread': '112.426', 'groupId': 'OG000'}, {'value': '7.21', 'spread': '10.051', 'groupId': 'OG001'}, {'value': '105.86', 'spread': '275.125', 'groupId': 'OG002'}, {'value': '18.48', 'spread': '26.347', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.68', 'ciLowerLimit': '-7.35', 'ciUpperLimit': '3.99', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.626', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Nausea', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.00', 'ciLowerLimit': '-6.62', 'ciUpperLimit': '2.62', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.180', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Nausea', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.43', 'ciLowerLimit': '-11.64', 'ciUpperLimit': '12.49', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.717', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Diarrhea', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.48', 'ciLowerLimit': '-14.11', 'ciUpperLimit': '5.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.597', 'groupDescription': 'Diarrhea', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '-1.10', 'ciUpperLimit': '2.57', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.794', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Upper abdominal pain', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.61', 'ciLowerLimit': '-1.17', 'ciUpperLimit': '2.40', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.775', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Upper abdominal pain', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.14', 'ciLowerLimit': '-5.08', 'ciUpperLimit': '2.79', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.705', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Lower abdominal pain', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.56', 'ciLowerLimit': '-42.19', 'ciUpperLimit': '79.32', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '27.886', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Lower abdominal pain', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.46', 'ciLowerLimit': '-3.65', 'ciUpperLimit': '8.56', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.801', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Indigestion', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.94', 'ciLowerLimit': '-3.71', 'ciUpperLimit': '1.83', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.242', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Indigestion', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.83', 'ciLowerLimit': '-48.73', 'ciUpperLimit': '60.38', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '19.649', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Constipation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.76', 'ciLowerLimit': '-28.38', 'ciUpperLimit': '33.91', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.219', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Constipation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.36', 'ciLowerLimit': '-35.56', 'ciUpperLimit': '6.83', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.811', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Bloating', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '67.12', 'ciLowerLimit': '-22.88', 'ciUpperLimit': '157.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '41.961', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Bloating', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '98.65', 'ciLowerLimit': '-58.01', 'ciUpperLimit': '255.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '74.566', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Flatulence', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.27', 'ciLowerLimit': '-5.22', 'ciUpperLimit': '27.76', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.928', 'estimateComment': 'Reference arm is BG00012 240 mg BID; negative values means reduced side effect.', 'groupDescription': 'Flatulence', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Week 5 to Week 8', 'description': 'Duration is calculated as follows: \\[(GI side effect) end date/time - (GI side effect) start date/time\\]/3600. For GI side effects with no end date, the end date is imputed using the last diary date/time. For subjects with more than 1 GI episode during a visit interval, the average duration for the study visit interval is used. The average duration is calculated as the total duration of the GI side effect / the total number of GI side effects.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the safety population who have at least 1 diary entry of the relevant questionnaire data during the visit interval; n=number of participants with the given GI episode during the visit interval.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'FG001', 'title': 'BG00012', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'FG002', 'title': 'BG00012 + ASA', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.'}, {'id': 'FG003', 'title': 'BG00012 Slow Titration', 'description': 'Participants received BG00012 for 8 weeks (120 mg once daily \\[QD\\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '43'}, {'groupId': 'FG003', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '36'}, {'groupId': 'FG003', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Randomized But Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrew due to Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Physician', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '172', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'BG001', 'title': 'BG00012', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'BG002', 'title': 'BG00012 + ASA', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.'}, {'id': 'BG003', 'title': 'BG00012 Slow Titration', 'description': 'Participants received BG00012 for 8 weeks (120 mg once daily \\[QD\\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.5', 'spread': '8.78', 'groupId': 'BG000'}, {'value': '39.0', 'spread': '9.61', 'groupId': 'BG001'}, {'value': '38.1', 'spread': '10.29', 'groupId': 'BG002'}, {'value': '36.2', 'spread': '9.33', 'groupId': 'BG003'}, {'value': '37.2', 'spread': '9.54', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '25 to 34 years', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '79', 'groupId': 'BG004'}]}]}, {'title': '35 to 44 years', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}]}]}, {'title': '45 to 55 years', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '72', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized and treated participants'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 173}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-04', 'studyFirstSubmitDate': '2012-03-29', 'resultsFirstSubmitDate': '2016-05-04', 'studyFirstSubmitQcDate': '2012-03-30', 'lastUpdatePostDateStruct': {'date': '2016-06-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-05-04', 'studyFirstPostDateStruct': {'date': '2012-04-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS)', 'timeFrame': 'Day 1 to Week 8', 'description': 'Participant-reported flushing side effect events during the treatment period recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).'}, {'measure': 'Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 (Combined), as Assessed by MFSS', 'timeFrame': 'Week 1 to Week 4', 'description': 'Participant-reported flushing side effect events during Weeks 1 to 4 recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).'}, {'measure': 'Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 (Combined), as Assessed by MFSS', 'timeFrame': 'Week 5 to Week 8', 'description': 'Participant-reported flushing side effect events during Weeks 1 to 4 recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).'}, {'measure': 'Worst Severity Scores of Overall Flushing During Weeks 1 to 4 of Treatment (Combined), as Assessed by MFSS', 'timeFrame': 'Day 1 to Week 4', 'description': 'Worst severity of participant-reported flushing events during Weeks 1-4 of treatment combined, recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).'}, {'measure': 'Worst Severity Scores of Overall Flushing During Weeks 5 to 8 of Treatment (Combined), as Assessed by MFSS', 'timeFrame': 'Week 5 to Week 8', 'description': 'Worst severity of participant-reported flushing events during Weeks 1-4 of treatment combined, recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin.This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).'}, {'measure': 'Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Global Flushing Severity Scale (MGFSS)', 'timeFrame': 'Day 2 to Week 8', 'description': 'Participant-reported flushing events during the overall treatment period, recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to events reported in the 24 hours after the first dose on Day 1.'}, {'measure': 'Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MGFSS', 'timeFrame': 'Day 2 to Week 4', 'description': 'Participant-reported flushing events during Weeks 1 to 4 of treatment (combined), recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to events reported in the 24 hours after the first dose on Day 1.'}, {'measure': 'Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MGFSS', 'timeFrame': 'Week 5 to Week 8', 'description': 'Participant-reported flushing events during Weeks 5 to 8 of treatment (combined), recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to last 24 hours flushing score.'}, {'measure': 'Percentage of Participants Reporting Gastrointestinal (GI) Events During the Overall Treatment Period, as Assessed by the Modified Acute Gastrointestinal Scale (MAGISS)', 'timeFrame': 'Day 1 to Week 8', 'description': 'The MAGISS is a participant-reported questionnaire about side effects of the gastrointestinal system following drug administration, and is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. A participant was considered having overall GI side effect if he/she had a score of \\>=1 for at least one of the GI side effects including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating and flatulence.'}, {'measure': 'Percentage of Participants Reporting GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS', 'timeFrame': 'Day 1 to Week 4', 'description': 'The MAGISS is a participant-reported questionnaire about side effects of the gastrointestinal system following drug administration, and is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. A participant was considered having overall GI side effect if he/she had a score of \\>=1 for at least one of the GI side effects including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating and flatulence.'}, {'measure': 'Percentage of Participants Reporting GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS', 'timeFrame': 'Week 5 to Week 8', 'description': 'The MAGISS is a participant-reported questionnaire about side effects of the gastrointestinal system following drug administration, and is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. A participant was considered having overall GI side effect if he/she had a score of \\>=1 for at least one of the GI side effects including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating and flatulence.'}, {'measure': 'Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS', 'timeFrame': 'Day 1 to Week 4', 'description': 'Severity of GI-related events using the MAGISS to measure GI symptoms (nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, flatulence), based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms.'}, {'measure': 'Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS', 'timeFrame': 'Week 5 to Week 8', 'description': 'Severity of GI-related events using the MAGISS to measure GI symptoms (nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, flatulence), based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms.'}, {'measure': 'Percentage of Participants Reporting GI Events During the Overall Treatment Period, as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS)', 'timeFrame': 'Day 1 to Week 8', 'description': 'The MOGISS is a questionnaire about overall side effects related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. Participants were to answer the questions at the same time each day, before the morning drug administration.'}, {'measure': 'Percentage of Participants Reporting GI Events During Weeks 1 to 4 (Combined), as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS)', 'timeFrame': 'Week 1 to Week 4', 'description': 'The MOGISS is a questionnaire about overall side effects related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. Participants were to answer the questions at the same time each day, before the morning drug administration.'}, {'measure': 'Percentage of Participants Reporting GI Events During Weeks 5 to 8 (Combined), as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS)', 'timeFrame': 'Week 5 to Week 8', 'description': 'The MOGISS is a questionnaire about overall side effects related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. Participants were to answer the questions at the same time each day, before the morning drug administration.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs)', 'timeFrame': 'Day 1 up to end of Safety Follow-up (9 weeks)', 'description': 'AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes. An AE was considered treatment-emergent if it occurred after the start of study treatment or was present prior to the start of study treatment but subsequently worsened.'}, {'measure': 'Clinical Laboratory Shifts From Baseline in Reported Values: Hematology', 'timeFrame': 'Day 1 to Week 8', 'description': 'Number of participants with clinical laboratory shifts from baseline in hematology values. Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. abs=absolute'}, {'measure': 'Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry', 'timeFrame': 'Day 1 to Week 8', 'description': 'Number of participants with clinical laboratory shifts from baseline in blood chemistry values. Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. ALP=alkaline phosphatase, ALT=alanine aminotransferase, AST=aspartate aminotransferase, GGT=gamma-glutamyl transferase, LDH=lactate dehydrogenase, BUN=blood urea nitrogen.'}, {'measure': 'Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis', 'timeFrame': 'Day 1 to Week 8', 'description': 'Number of participants with clinical laboratory shifts from baseline in urinalysis values.Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. Shift to positive includes negative to positive and unknown to positive. RBC=red blood cells, WBC=white blood cells.'}, {'measure': 'Number of Participants With Abnormalities in Vital Signs', 'timeFrame': 'Day 1 to Week 8', 'description': '↑=increase; ↓=decrease; BL=baseline; bpm=beats per minute; SBP=systolic blood pressure; DBP=diastolic blood pressure; b/m=breaths per minute'}, {'measure': 'Number of Participants With Shifts From Baseline in Electrocardiogram (ECG) Results', 'timeFrame': 'Day 1 to Week 8', 'description': "Shift to 'abnormal, not adverse event' includes unknown or normal to 'abnormal, not adverse event.' Shift to 'abnormal, adverse event' includes unknown or normal to 'abnormal, adverse event.'"}, {'measure': 'Duration of Flushing Events During the Overall Treatment Period, Based on MFSS', 'timeFrame': 'Day 1 to Week 8', 'description': 'For participants with more than 1 flushing episode during a visit interval, the average duration for the visit interval was used. The average duration is calculated as: the total duration of all flushing episodes / the total number of flushing episodes.'}, {'measure': 'Duration of Flushing Events During the Weeks 1 to 4 (Combined), Based on MFSS', 'timeFrame': 'Week 1 to Week 4', 'description': 'For participants with more than 1 flushing episode during a visit interval, the average duration for the visit interval was used. The average duration is calculated as: the total duration of all flushing episodes / the total number of flushing episodes.'}, {'measure': 'Duration of Flushing Events During the Weeks 5 to 8 (Combined), Based on MFSS', 'timeFrame': 'Week 5 to Week 8', 'description': 'For participants with more than 1 flushing episode during a visit interval, the average duration for the visit interval was used. The average duration is calculated as: the total duration of all flushing episodes / the total number of flushing episodes.'}, {'measure': 'Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS', 'timeFrame': 'Day 1 to Week 8', 'description': 'Duration is calculated as follows: \\[(GI side effect) end date/time - (GI side effect) start date/time\\]/3600. For GI side effects with no end date, the end date is imputed using the last diary date/time. For subjects with more than 1 GI episode during a visit interval, the average duration for the study visit interval is used. The average duration is calculated as the total duration of the GI side effect / the total number of GI side effects.'}, {'measure': 'Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS', 'timeFrame': 'Week 1 to Week 4', 'description': 'Duration is calculated as follows: \\[(GI side effect) end date/time - (GI side effect) start date/time\\]/3600. For GI side effects with no end date, the end date is imputed using the last diary date/time. For subjects with more than 1 GI episode during a visit interval, the average duration for the study visit interval is used. The average duration is calculated as the total duration of the GI side effect / the total number of GI side effects.'}, {'measure': 'Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS', 'timeFrame': 'Week 5 to Week 8', 'description': 'Duration is calculated as follows: \\[(GI side effect) end date/time - (GI side effect) start date/time\\]/3600. For GI side effects with no end date, the end date is imputed using the last diary date/time. For subjects with more than 1 GI episode during a visit interval, the average duration for the study visit interval is used. The average duration is calculated as the total duration of the GI side effect / the total number of GI side effects.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['BG00012', 'gastrointestinal events', 'flushing events', 'dose titration', 'pre-medication', 'aspirin'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '25999183', 'type': 'RESULT', 'citation': "O'Gorman J, Russell HK, Li J, Phillips G, Kurukulasuriya NC, Viglietta V. Effect of Aspirin Pretreatment or Slow Dose Titration on Flushing and Gastrointestinal Events in Healthy Volunteers Receiving Delayed-release Dimethyl Fumarate. Clin Ther. 2015 Jul 1;37(7):1402-1419.e5. doi: 10.1016/j.clinthera.2015.03.028. Epub 2015 May 19."}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to evaluate whether premedication with 325 mg microcoated aspirin (ASA) tablet or a slow-titration dosing schedule of BG00012 reduces the incidence and severity of flushing and GI events following oral administration of BG00012 dosed at 240 mg twice a day (BID) in healthy volunteers. The secondary objective of this study is to evaluate the safety and tolerability of BG00012 when administered orally as a 240 mg BID dose regimen with and without 325 mg ASA premedication or following a slow-titration dosing schedule in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Must give written informed consent and any authorizations required by local law\n* Must have a body mass index (BMI) of between 18.0 to 34.0 kg/m\\^2,inclusive.\n* Ability to complete the tolerability scales by accurately using the hand-held subject reporting device\n* Subjects of childbearing potential must be willing to practice effective contraception\n\nKey Exclusion Criteria:\n\n* History of clinically significant diseases\n* History of severe allergic or anaphylactic reactions\n* Intolerance to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs)\n* Diarrhea, constipation, abdominal pain, flushing or nausea within 28 days prior to Day 1\n\nNOTE: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01568112', 'briefTitle': 'Effect of Aspirin Pretreatment or Slow Dose Titration on Flushing and Gastrointestinal Events in Healthy Volunteers Receiving Delayed-release Dimethyl Fumarate', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'A Randomized, Double-Blind, Phase 3b Study to Evaluate Effects of Aspirin or Dose Titration on Flushing and Gastrointestinal Events Following Oral Administration of BG00012 Dosed at 240 mg BID', 'orgStudyIdInfo': {'id': '109HV321'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BG00012', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.', 'interventionNames': ['Drug: BG00012 (dimethyl fumarate)', 'Drug: BG00012 placebo', 'Drug: ASA placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.', 'interventionNames': ['Drug: BG00012 placebo', 'Drug: ASA placebo']}, {'type': 'EXPERIMENTAL', 'label': 'BG00012 + ASA', 'description': 'Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.', 'interventionNames': ['Drug: BG00012 (dimethyl fumarate)', 'Drug: BG00012 placebo', 'Drug: ASA']}, {'type': 'EXPERIMENTAL', 'label': 'BG00012 Slow Titration', 'description': 'Participants received BG00012 for 8 weeks (120 mg once daily \\[QD\\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.', 'interventionNames': ['Drug: BG00012 (dimethyl fumarate)', 'Drug: BG00012 placebo', 'Drug: ASA placebo']}], 'interventions': [{'name': 'BG00012 (dimethyl fumarate)', 'type': 'DRUG', 'otherNames': ['BG-12', 'oral fumarate', 'DMF'], 'description': 'Each capsule contains 120 mg dimethyl fumarate (DMF). Fast titration involves taking one 120 mg capsule in the morning and one in the evening (240 mg daily) for one week, and then escalating to a dose of 480 mg daily (two capsules morning and evening) for the remainder of the study.Slow titration expands the dose escalation time to 4 weeks.', 'armGroupLabels': ['BG00012', 'BG00012 + ASA', 'BG00012 Slow Titration']}, {'name': 'BG00012 placebo', 'type': 'DRUG', 'description': 'Placebo matching BG00012', 'armGroupLabels': ['BG00012', 'BG00012 + ASA', 'BG00012 Slow Titration', 'Placebo']}, {'name': 'ASA', 'type': 'DRUG', 'otherNames': ['acetylsalicylic acid', 'aspirin'], 'description': '325 mg microcoated aspirin (ASA)', 'armGroupLabels': ['BG00012 + ASA']}, {'name': 'ASA placebo', 'type': 'DRUG', 'description': 'Placebo matching aspirin', 'armGroupLabels': ['BG00012', 'BG00012 Slow Titration', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biogen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biogen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}