Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT01062256
Status:
COMPLETED
Last Update Posted:
2013-02-25
First Post:
2010-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Count Coughs in Subjects With Acute Upper Respiratory Tract Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006140', 'term': 'Guaifenesin'}], 'ancestors': [{'id': 'D006139', 'term': 'Guaiacol'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D002396', 'term': 'Catechols'}, {'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.gov_Inquires@Pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer Clinical Trials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The same event may have appeared as both an adverse event (AE) and a serious adverse event (SAE). However, what was presented were distinct events. An event may have been categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'One placebo tablet administered orally as a single dose', 'otherNumAtRisk': 55, 'otherNumAffected': 3, 'seriousNumAtRisk': 55, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Buckwheat Honey', 'description': '10 milliliters (mL) administered orally as a single dose', 'otherNumAtRisk': 103, 'otherNumAffected': 3, 'seriousNumAtRisk': 103, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Guaifenesin', 'description': 'One 400 milligrams (mg) immediate release tablet administered orally as a single dose', 'otherNumAtRisk': 107, 'otherNumAffected': 4, 'seriousNumAtRisk': 107, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Dry throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Feeling jittery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Cough Bouts Over 4-hour Postdose Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'One placebo tablet administered orally as a single dose'}, {'id': 'OG001', 'title': 'Buckwheat Honey', 'description': '10 milliliters (mL) administered orally as a single dose'}, {'id': 'OG002', 'title': 'Guaifenesin', 'description': 'One 400 milligrams (mg) immediate release tablet administered orally as a single dose'}], 'classes': [{'categories': [{'measurements': [{'value': '139.6', 'spread': '140.6', 'groupId': 'OG000'}, {'value': '131.3', 'spread': '138.8', 'groupId': 'OG001'}, {'value': '126.4', 'spread': '126.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.216', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.64', 'ciUpperLimit': '1.10', 'pValueComment': 'p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) as the offset parameter.', 'groupDescription': 'Pairwise comparison of number of cough bouts over 4-hour postdose period.', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.513', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.72', 'ciUpperLimit': '1.18', 'pValueComment': 'p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) as the offset parameter.', 'groupDescription': 'Pairwise comparison of number of cough bouts over 4-hour postdose period.', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.459', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.38', 'pValueComment': 'p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) as the offset parameter.', 'groupDescription': 'Pairwise comparison of number of cough bouts over 4-hour postdose period.', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0 to 4 hours postdose', 'description': 'Cough bouts defined as one or several cough sounds occurring after one inspiration (one explosive bout between inspiration and expiration). Audio recordings made of participants during 4-hour period after dosing. Based on audio recordings, a trained cough counter counted and recorded the number of cough bouts.', 'unitOfMeasure': 'Cough bouts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all randomized participants who provided baseline cough counts and were dosed with study product.'}, {'type': 'SECONDARY', 'title': 'Number of Cough Bouts Over 2-hour Postdose Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'One placebo tablet administered orally as a single dose'}, {'id': 'OG001', 'title': 'Buckwheat Honey', 'description': '10 milliliters (mL) administered orally as a single dose'}, {'id': 'OG002', 'title': 'Guaifenesin', 'description': 'One 400 milligrams (mg) immediate release tablet administered orally as a single dose'}], 'classes': [{'categories': [{'measurements': [{'value': '83.8', 'spread': '81.9', 'groupId': 'OG000'}, {'value': '79.8', 'spread': '81.8', 'groupId': 'OG001'}, {'value': '75.0', 'spread': '71.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.195', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.65', 'ciUpperLimit': '1.09', 'pValueComment': 'p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) as the offset parameter.', 'groupDescription': 'Pairwise comparison of number of cough bouts over 2-hour postdose period.', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.438', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.16', 'pValueComment': 'p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site and baseline of cough bouts terms with log(exposure time)as the offset parameter.', 'groupDescription': 'Pairwise comparison of number of cough bouts over 2-hour postdose period.', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.497', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.34', 'pValueComment': 'p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site and baseline of cough bouts terms with log(exposure time)as the offset parameter.', 'groupDescription': 'Pairwise comparison of number of cough bouts over 2-hour postdose period.', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0 to 2 hours postdose', 'description': 'Cough bouts defined as one or several cough sounds occurring after one inspiration (one explosive bout between inspiration and expiration). Audio recordings made of participants during first 2 hours postdose. Based on audio recordings, a trained cough counter counted and recorded the number of cough bouts.', 'unitOfMeasure': 'cough bouts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Number of Cough Bouts Within Each 15-minute Time Interval Postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'One placebo tablet administered orally as a single dose'}, {'id': 'OG001', 'title': 'Buckwheat Honey', 'description': '10 milliliters (mL) administered orally as a single dose'}, {'id': 'OG002', 'title': 'Guaifenesin', 'description': 'One 400 milligrams (mg) immediate release tablet administered orally as a single dose'}], 'classes': [{'title': '15 minutes', 'categories': [{'measurements': [{'value': '14.9', 'spread': '16.8', 'groupId': 'OG000'}, {'value': '14.5', 'spread': '14.3', 'groupId': 'OG001'}, {'value': '14.2', 'spread': '12.4', 'groupId': 'OG002'}]}]}, {'title': '30 minutes', 'categories': [{'measurements': [{'value': '12.4', 'spread': '13.0', 'groupId': 'OG000'}, {'value': '10.9', 'spread': '10.9', 'groupId': 'OG001'}, {'value': '11.0', 'spread': '11.0', 'groupId': 'OG002'}]}]}, {'title': '45 minutes', 'categories': [{'measurements': [{'value': '11.5', 'spread': '11.4', 'groupId': 'OG000'}, {'value': '10.6', 'spread': '12.2', 'groupId': 'OG001'}, {'value': '9.5', 'spread': '9.5', 'groupId': 'OG002'}]}]}, {'title': '60 minutes', 'categories': [{'measurements': [{'value': '10.1', 'spread': '10.5', 'groupId': 'OG000'}, {'value': '9.6', 'spread': '10.0', 'groupId': 'OG001'}, {'value': '8.7', 'spread': '9.5', 'groupId': 'OG002'}]}]}, {'title': '75 minutes', 'categories': [{'measurements': [{'value': '8.1', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '10.0', 'groupId': 'OG001'}, {'value': '8.2', 'spread': '8.6', 'groupId': 'OG002'}]}]}, {'title': '90 minutes', 'categories': [{'measurements': [{'value': '9.4', 'spread': '10.3', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '10.5', 'groupId': 'OG001'}, {'value': '8.0', 'spread': '9.1', 'groupId': 'OG002'}]}]}, {'title': '105 minutes', 'categories': [{'measurements': [{'value': '9.6', 'spread': '10.0', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '9.9', 'groupId': 'OG001'}, {'value': '7.9', 'spread': '9.1', 'groupId': 'OG002'}]}]}, {'title': '120 minutes', 'categories': [{'measurements': [{'value': '8.3', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '8.4', 'spread': '9.8', 'groupId': 'OG001'}, {'value': '7.9', 'spread': '9.3', 'groupId': 'OG002'}]}]}, {'title': '135 minutes', 'categories': [{'measurements': [{'value': '6.8', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '9.6', 'groupId': 'OG001'}, {'value': '6.6', 'spread': '8.1', 'groupId': 'OG002'}]}]}, {'title': '150 minutes', 'categories': [{'measurements': [{'value': '7.9', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '8.7', 'groupId': 'OG001'}, {'value': '6.8', 'spread': '7.8', 'groupId': 'OG002'}]}]}, {'title': '165 minutes', 'categories': [{'measurements': [{'value': '7.7', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '8.3', 'groupId': 'OG001'}, {'value': '7.0', 'spread': '8.2', 'groupId': 'OG002'}]}]}, {'title': '180 minutes', 'categories': [{'measurements': [{'value': '6.5', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '8.3', 'groupId': 'OG001'}, {'value': '6.9', 'spread': '8.0', 'groupId': 'OG002'}]}]}, {'title': '195 minutes', 'categories': [{'measurements': [{'value': '6.1', 'spread': '7.8', 'groupId': 'OG000'}, {'value': '6.3', 'spread': '8.4', 'groupId': 'OG001'}, {'value': '5.9', 'spread': '6.8', 'groupId': 'OG002'}]}]}, {'title': '210 minutes', 'categories': [{'measurements': [{'value': '6.8', 'spread': '7.8', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '7.6', 'groupId': 'OG001'}, {'value': '6.3', 'spread': '7.6', 'groupId': 'OG002'}]}]}, {'title': '225 minutes', 'categories': [{'measurements': [{'value': '7.2', 'spread': '8.9', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '7.5', 'groupId': 'OG001'}, {'value': '6.0', 'spread': '7.6', 'groupId': 'OG002'}]}]}, {'title': '240 minutes', 'categories': [{'measurements': [{'value': '7.1', 'spread': '9.1', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '8.7', 'groupId': 'OG001'}, {'value': '6.3', 'spread': '8.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.250', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '0.64', 'ciUpperLimit': '1.12', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts within 15 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.802', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.25', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts within 15 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.188', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.14', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.39', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts within 15 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.091', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.78', 'ciLowerLimit': '0.58', 'ciUpperLimit': '1.04', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 15 and 30 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.465', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.19', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 15 and 30 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.207', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.16', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.46', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 15 and 30 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.122', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.81', 'ciLowerLimit': '0.62', 'ciUpperLimit': '1.06', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 30 and 45 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.165', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.07', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 30 and 45 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.711', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.32', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 30 and 45 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.215', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.64', 'ciUpperLimit': '1.11', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 45 and 60 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.367', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.67', 'ciUpperLimit': '1.16', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 45 and 60 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.687', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.35', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 45 and 60 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.730', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.67', 'ciUpperLimit': '1.32', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 60 and 75 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.923', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.74', 'ciUpperLimit': '1.39', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 60 and 75 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.573', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.40', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 60 and 75 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.289', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.61', 'ciUpperLimit': '1.16', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 75 and 90 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.379', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '0.64', 'ciUpperLimit': '1.18', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 75 and 90 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.785', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.79', 'ciUpperLimit': '1.37', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 75 and 90 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.194', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.60', 'ciUpperLimit': '1.11', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 90 and 105 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.212', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.62', 'ciUpperLimit': '1.11', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 90 and 105 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.901', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.34', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 90 and 105 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.600', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.70', 'ciUpperLimit': '1.23', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 105 and 120 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.853', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.74', 'ciUpperLimit': '1.29', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 105 and 120 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.736', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.79', 'ciUpperLimit': '1.39', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 105 and 120 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.744', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.70', 'ciUpperLimit': '1.30', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 120 and 135 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.904', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.72', 'ciUpperLimit': '1.33', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 120 and 135 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.828', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.39', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 120 and 135 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.147', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.59', 'ciUpperLimit': '1.08', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 135 and 150 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.345', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '0.65', 'ciUpperLimit': '1.16', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 135 and 150 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.532', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.44', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 135 and 150 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.261', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.61', 'ciUpperLimit': '1.15', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 150 and 165 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.601', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.24', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 150 and 165 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.470', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.11', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.47', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 150 and 165 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.834', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.32', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 165 and 180 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.628', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.43', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 165 and 180 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.481', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.11', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.48', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 165 and 180 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.749', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.65', 'ciUpperLimit': '1.37', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 180 and 195 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.857', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.70', 'ciUpperLimit': '1.35', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 180 and 195 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.847', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.41', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 180 and 195 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.146', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.54', 'ciUpperLimit': '1.09', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 195 and 210 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.702', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.29', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 195 and 210 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.228', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.22', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.69', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 195 and 210 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.130', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '0.51', 'ciUpperLimit': '1.09', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 210 and 225 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.371', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '0.60', 'ciUpperLimit': '1.21', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 210 and 225 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.430', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.14', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.58', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 210 and 225 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.177', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '0.51', 'ciUpperLimit': '1.13', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 225 and 240 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.580', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.64', 'ciUpperLimit': '1.28', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 225 and 240 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.333', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.70', 'pValueComment': 'p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)', 'groupDescription': 'Pairwise comparison of the number of cough bouts between 225 and 240 minutes postdose', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'every 15 minutes postdose up to 240 minutes postdose', 'description': 'Cough bouts defined as one or several cough sounds occurring after one inspiration (one explosive bout between inspiration and expiration). Audio recordings made of participants during 4-hour (240-minute) period after dosing. Based on audio recordings, a trained cough counter counted and recorded the number of cough bouts in 15 minute intervals.', 'unitOfMeasure': 'cough bouts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cough Severity Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'One placebo tablet administered orally as a single dose'}, {'id': 'OG001', 'title': 'Buckwheat Honey', 'description': '10 milliliters (mL) administered orally as a single dose'}, {'id': 'OG002', 'title': 'Guaifenesin', 'description': 'One 400 milligrams (mg) immediate release tablet administered orally as a single dose'}], 'classes': [{'title': '1 hour postdose', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.5', 'groupId': 'OG002'}]}]}, {'title': '2 hours postdose', 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': '3 hours postdose', 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': '4 hours postdose', 'categories': [{'measurements': [{'value': '1.0', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '0.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.264', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.27', 'pValueComment': 'p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.', 'groupDescription': 'Pairwise comparison of change from baseline in cough severity at 1 hour postdose', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.737', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '0.14', 'pValueComment': 'p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.', 'groupDescription': 'Pairwise comparison of change from baseline in cough severity at 1 hour postdose', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.078', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '0.01', 'pValueComment': 'p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.', 'groupDescription': 'Pairwise comparison of change from baseline in cough severity at 1 hour postdose', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.125', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '0.36', 'pValueComment': 'p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.', 'groupDescription': 'Pairwise comparison of change from baseline in cough severity at 2 hour postdose', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.688', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.24', 'pValueComment': 'p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.', 'groupDescription': 'Pairwise comparison of change from baseline in cough severity at 2 hour postdose', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.166', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.29', 'ciUpperLimit': '0.05', 'pValueComment': 'p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.', 'groupDescription': 'Pairwise comparison of change from baseline in cough severity at 2 hour postdose', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.233', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.13', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '0.35', 'pValueComment': 'p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.', 'groupDescription': 'Pairwise comparison of change from baseline in cough severity at 3 hour postdose', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.848', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '0.19', 'pValueComment': 'p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.', 'groupDescription': 'Pairwise comparison of change from baseline in cough severity at 3 hour postdose', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.093', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '0.03', 'pValueComment': 'p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.', 'groupDescription': 'Pairwise comparison of change from baseline in cough severity at 3 hour postdose', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.406', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.34', 'pValueComment': 'p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.', 'groupDescription': 'Pairwise comparison of change from baseline in cough severity at 4 hour postdose', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.991', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.00', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '0.24', 'pValueComment': 'p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.', 'groupDescription': 'Pairwise comparison of change from baseline in cough severity at 4 hour postdose', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.306', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.10', 'ciLowerLimit': '-0.30', 'ciUpperLimit': '0.09', 'pValueComment': 'p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.', 'groupDescription': 'Pairwise comparison of change from baseline in cough severity at 4 hour postdose', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '1, 2, 3, and 4 hours postdose', 'description': "Participant's self-assessment of cough severity using a 4-point categorical scale (0 = none; no cough present, 1 = mild; cough present but with minimal awareness, easily tolerated, 2 = moderate; cough definitely present and bothersome, but tolerable, or 3 = severe; cough was hard to tolerate; may have caused interference with daily activities and sleeping). Change from baseline derived by subtracting post baseline cough severity from baseline cough severity. Change from baseline values could have ranged from -1.0 to 3.0 with higher values indicative of greater improvement.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Global Evaluation of Study Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'One placebo tablet administered orally as a single dose'}, {'id': 'OG001', 'title': 'Buckwheat Honey', 'description': '10 milliliters (mL) administered orally as a single dose'}, {'id': 'OG002', 'title': 'Guaifenesin', 'description': 'One 400 milligrams (mg) immediate release tablet administered orally as a single dose'}], 'classes': [{'title': 'Poor', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Fair', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}, {'title': 'Very Good', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}, {'title': 'Excellent', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.254', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Goodman-Kruskal Gamma statistic', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.15', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '0.39', 'pValueComment': 'p-values from Cochran-Mantel-Haenszel test with modified ridit scores, controlling for gender, time stratum, and site.', 'groupDescription': 'Pairwise comparison of global evaluation of study medication.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.949', 'groupIds': ['OG000', 'OG002'], 'paramType': 'weighted Goodman-Kruskal Gamma statistic', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.25', 'ciUpperLimit': '0.23', 'pValueComment': 'p-values from Cochran-Mantel-Haenszel test with modified ridit scores, controlling for gender, time stratum, and site.', 'groupDescription': 'Pairwise comparison of global evaluation of study medication.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.256', 'groupIds': ['OG001', 'OG002'], 'paramType': 'weighted Goodman-Kruskal Gamma statistic', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.08', 'pValueComment': 'p-values from Cochran-Mantel-Haenszel test with modified ridit scores, controlling for gender, time stratum, and site.', 'groupDescription': 'Pairwise comparison of global evaluation of study medication.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '4 hours postdose or early termination', 'description': 'Participant-rated evaluation of study product; Participants responded to the following question:\n\n"How would you rate this product as a cough reliever?" 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participant With Cough Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'One placebo tablet administered orally as a single dose'}, {'id': 'OG001', 'title': 'Buckwheat Honey', 'description': '10 milliliters (mL) administered orally as a single dose'}, {'id': 'OG002', 'title': 'Guaifenesin', 'description': 'One 400 milligrams (mg) immediate release tablet administered orally as a single dose'}], 'classes': [{'title': 'Moderate', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': "Participant's self-assessment of cough severity using 4-point categorical scale (0 = none; no cough present, 1 = mild; cough present but with minimal awareness, easily tolerated, 2 = moderate; cough definitely present and bothersome, but tolerable, or 3 = severe; cough was hard to tolerate; may have caused interference with daily activities and sleeping). Participants were eligible for study if severity of cough at baseline was at least moderate.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'One placebo tablet administered orally as a single dose'}, {'id': 'FG001', 'title': 'Buckwheat Honey', 'description': '10 milliliters (mL) administered orally as a single dose'}, {'id': 'FG002', 'title': 'Guaifenesin', 'description': 'One 400 milligrams (mg) immediate release tablet administered orally as a single dose'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '103'}, {'groupId': 'FG002', 'numSubjects': '107'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '96'}, {'groupId': 'FG002', 'numSubjects': '103'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Administrative', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Participants stratified by gender and time of dosing (before or at 3:00 pm versus after 3:00 pm).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}, {'value': '265', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'One placebo tablet administered orally as a single dose'}, {'id': 'BG001', 'title': 'Buckwheat Honey', 'description': '10 milliliters (mL) administered orally as a single dose'}, {'id': 'BG002', 'title': 'Guaifenesin', 'description': 'One 400 milligrams (mg) immediate release tablet administered orally as a single dose'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.9', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '33.5', 'spread': '11.2', 'groupId': 'BG001'}, {'value': '32.4', 'spread': '11.1', 'groupId': 'BG002'}, {'value': '32.3', 'spread': '10.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '159', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 265}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-20', 'studyFirstSubmitDate': '2010-02-01', 'resultsFirstSubmitDate': '2011-02-09', 'studyFirstSubmitQcDate': '2010-02-02', 'lastUpdatePostDateStruct': {'date': '2013-02-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-02-09', 'studyFirstPostDateStruct': {'date': '2010-02-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participant With Cough Severity', 'timeFrame': 'Baseline', 'description': "Participant's self-assessment of cough severity using 4-point categorical scale (0 = none; no cough present, 1 = mild; cough present but with minimal awareness, easily tolerated, 2 = moderate; cough definitely present and bothersome, but tolerable, or 3 = severe; cough was hard to tolerate; may have caused interference with daily activities and sleeping). Participants were eligible for study if severity of cough at baseline was at least moderate."}], 'primaryOutcomes': [{'measure': 'Number of Cough Bouts Over 4-hour Postdose Period', 'timeFrame': '0 to 4 hours postdose', 'description': 'Cough bouts defined as one or several cough sounds occurring after one inspiration (one explosive bout between inspiration and expiration). Audio recordings made of participants during 4-hour period after dosing. Based on audio recordings, a trained cough counter counted and recorded the number of cough bouts.'}], 'secondaryOutcomes': [{'measure': 'Number of Cough Bouts Over 2-hour Postdose Period', 'timeFrame': '0 to 2 hours postdose', 'description': 'Cough bouts defined as one or several cough sounds occurring after one inspiration (one explosive bout between inspiration and expiration). Audio recordings made of participants during first 2 hours postdose. Based on audio recordings, a trained cough counter counted and recorded the number of cough bouts.'}, {'measure': 'Number of Cough Bouts Within Each 15-minute Time Interval Postdose', 'timeFrame': 'every 15 minutes postdose up to 240 minutes postdose', 'description': 'Cough bouts defined as one or several cough sounds occurring after one inspiration (one explosive bout between inspiration and expiration). Audio recordings made of participants during 4-hour (240-minute) period after dosing. Based on audio recordings, a trained cough counter counted and recorded the number of cough bouts in 15 minute intervals.'}, {'measure': 'Change From Baseline in Cough Severity Scale', 'timeFrame': '1, 2, 3, and 4 hours postdose', 'description': "Participant's self-assessment of cough severity using a 4-point categorical scale (0 = none; no cough present, 1 = mild; cough present but with minimal awareness, easily tolerated, 2 = moderate; cough definitely present and bothersome, but tolerable, or 3 = severe; cough was hard to tolerate; may have caused interference with daily activities and sleeping). Change from baseline derived by subtracting post baseline cough severity from baseline cough severity. Change from baseline values could have ranged from -1.0 to 3.0 with higher values indicative of greater improvement."}, {'measure': 'Number of Participants With Global Evaluation of Study Medication', 'timeFrame': '4 hours postdose or early termination', 'description': 'Participant-rated evaluation of study product; Participants responded to the following question:\n\n"How would you rate this product as a cough reliever?" 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cough assessment in upper respiratory infection', 'guaifenesin', 'honey'], 'conditions': ['Infection']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=GG-09-06&StudyName=Study%20of%20Count%20Coughs%20in%20Subjects%20with%20Acute%20Upper%20Respiratory%20Tract%20Infections%20%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The objectives of this study are: a) to assess the feasibility and sensitivity of manually count cough bouts over a 4-hour period; b) to assess the effects of buckwheat honey and guaifenesin 400 mg immediate release tablets compared to placebo on the frequency and severity of acute cough due to upper respiratory tract infection and c) to evaluate the correlation between cough bout frequency and subjective assessments of cough severity. The hypotheses to be tested is that 10 ml of buckwheat honey and 400 mg of immediate release guaifenesin will significantly reduce the frequency and severity of cough compared to placebo over a 4-hour evaluation period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects at least 18 years of age and in generally good health who are experiencing an acute upper respiratory infection of 10 days or less in duration;\n* Subjects currently have acute cough self-rated as at least moderate due to an acute Upper Respiratory Infection (URTI) (i.e., cold or flu) as established by a study physician, nurse practitioner, or physician\'s assistant;\n* Subjects who have \\> 5 cough bouts during the 30 minute baseline assessment period\n\nExclusion Criteria:\n\n* Subjects who have acute, subchronic, or chronic cough due to any condition other than a URTI as established by the Investigator, nurse practitioner, or physician\'s assistant, in accordance with the American College of Chest Physicians (ACCP) Guidelines for Diagnosis and Management of Cough. Special attention should be paid to highly prevalent conditions commonly presenting with cough such as asthma, Chronic Obstructive Pulmonary Disease (COPD), and Gastroesophageal Reflux Disease (GERD) (N.B. Subjects with exercise-induced asthma may be eligible for the study as long as they have not experienced an episode of asthma within 24 hours of enrollment)\n* In the opinion of a study physician, nurse practitioner, or physician\'s assistant, subjects with sinusitis or who have a history of (within the past 2 years) frequent clinically significant sinusitis;\n* Subjects with a history (within the last 3 years) of alcohol abuse (i.e., consuming greater than or equal to 3 alcoholic drinks/day on a regular basis) or substance abuse (i.e., ingesting/smoking marijuana more than once a week at any time during the past 6 months or using any other recreational drug more than once during the past 6 months). (Note: One "drink" of alcohol=1 oz. liquor, 6 oz wine, 12 oz. beer.);'}, 'identificationModule': {'nctId': 'NCT01062256', 'briefTitle': 'Study of Count Coughs in Subjects With Acute Upper Respiratory Tract Infections', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'A Methodology Study to Assess Cough Counts in Subjects With Acute Upper Respiratory Tract Infections', 'orgStudyIdInfo': {'id': 'GG-09-06'}, 'secondaryIdInfos': [{'id': 'B4361001'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Guaifenesin', 'description': 'Guaifenesin', 'interventionNames': ['Drug: Guaifenesin']}, {'type': 'EXPERIMENTAL', 'label': 'Buckwheat Honey', 'description': 'Buckwheat Honey', 'interventionNames': ['Other: Buckwheat Honey']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'One placebo tablet administered orally as a single dose', 'armGroupLabels': ['Placebo']}, {'name': 'Guaifenesin', 'type': 'DRUG', 'description': 'One 400 mg immediate release tablet administered orally as a single dose', 'armGroupLabels': ['Guaifenesin']}, {'name': 'Buckwheat Honey', 'type': 'OTHER', 'description': '10 mL administered orally as a single dose', 'armGroupLabels': ['Buckwheat Honey']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46240', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '40509', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}