Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2026-03-01 @ 12:32 PM
Study NCT ID:
NCT04079933
Status:
COMPLETED
Last Update Posted:
2024-09-27
First Post:
2019-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Changes in Smokers Using An Oral Tobacco-Derived Nicotine Product
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064424', 'term': 'Tobacco Use'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Jeffery.S.Edmiston@altria.com', 'phone': '8043352366', 'title': 'Jeffery Edmiston, Functional Director Clinical Research', 'organization': 'Altria'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.', 'description': 'One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.', 'eventGroups': [{'id': 'EG000', 'title': 'Test (ad Libitum VBM-FG2)', 'description': 'Subjects were allowed to continue smoking their own brand of cigarettes ad libitum and were provided the option to use the test product (VBM-FG2 oral discs) also under ad libitum conditions', 'otherNumAtRisk': 92, 'deathsNumAtRisk': 92, 'otherNumAffected': 25, 'seriousNumAtRisk': 92, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control (no VBM-FG2)', 'description': 'Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 7, 'seriousNumAtRisk': 62, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Pulmonary congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Dry throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Urogenital trichomoniasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Pain in jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Cutaneous lupus erythematosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Bladder discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Summary Statistics of Percent Change From Baseline for Urinary Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) (%) (Per-Protocol Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (ad Libitum VBM-FG2)', 'description': 'Subjects were allowed to continue smoking their own brand of cigarettes ad libitum and were provided the option to use the test product (VBM-FG2 oral discs) also under ad libitum conditions'}, {'id': 'OG001', 'title': 'Control (no VBM-FG2)', 'description': 'Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks'}], 'classes': [{'title': 'Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.8', 'spread': '34.11', 'groupId': 'OG000'}, {'value': '13.8', 'spread': '45.56', 'groupId': 'OG001'}]}]}, {'title': 'Visit 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.5', 'spread': '60.16', 'groupId': 'OG000'}, {'value': '30.4', 'spread': '63.66', 'groupId': 'OG001'}]}]}, {'title': 'Visit 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.0', 'spread': '50.87', 'groupId': 'OG000'}, {'value': '29.2', 'spread': '46.70', 'groupId': 'OG001'}]}]}, {'title': 'End of Study/Early Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.4', 'spread': '62.42', 'groupId': 'OG000'}, {'value': '28.4', 'spread': '57.66', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2347', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.6', 'ciLowerLimit': '-33.5', 'ciUpperLimit': '8.27', 'estimateComment': 'Difference in Least Square (LS) means (Test - Control) using Mixed Effects Repeated Measures Model 1:\n\nPercent Change from baseline = study group + visit + study group\\*visit + subject + random error, fitted with unstructured covariance matrix.', 'groupDescription': 'Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline in urinary total NNAL', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline in urinary total NNAL'}, {'pValue': '0.2905', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.9', 'ciLowerLimit': '-33.9', 'ciUpperLimit': '10.2', 'estimateComment': 'Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:\n\n%Change from baseline = study group +visit +study group\\*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix.', 'groupDescription': 'Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline in urinary total NNAL', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline in urinary total NNAL'}], 'paramType': 'MEAN', 'timeFrame': 'Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)', 'description': "Summary statistics of percent change from baseline for urinary total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol \\[NNAL\\] (%) in each study visit are presented.\n\nBaseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1\n\nMean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a Statistical Analysis System (SAS®) procedure.", 'unitOfMeasure': 'percent change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Per-protocol population. All Per-Protocol Test and Control subjects were included in the analysis. If a value was missing for any subject at any visit, that subject's value was omitted from the analysis for that visit only."}, {'type': 'SECONDARY', 'title': 'Summary Statistics of Change From Baseline for Urinary Total NNAL (ng/g Creatinine) (Per-Protocol Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (ad Libitum VBM-FG2)', 'description': 'Subjects were allowed to continue smoking their own brand of cigarettes ad libitum and were provided the option to use the test product (VBM-FG2 oral discs) also under ad libitum conditions'}, {'id': 'OG001', 'title': 'Control (no VBM-FG2)', 'description': 'Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks'}], 'classes': [{'title': 'Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.99', 'spread': '212.505', 'groupId': 'OG000'}, {'value': '9.47', 'spread': '207.308', 'groupId': 'OG001'}]}]}, {'title': 'Visit 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.90', 'spread': '436.326', 'groupId': 'OG000'}, {'value': '76.50', 'spread': '310.423', 'groupId': 'OG001'}]}]}, {'title': 'Visit 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.23', 'spread': '303.806', 'groupId': 'OG000'}, {'value': '117.69', 'spread': '289.763', 'groupId': 'OG001'}]}]}, {'title': 'End of Study/Early Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81.33', 'spread': '345.110', 'groupId': 'OG000'}, {'value': '86.53', 'spread': '209.749', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9433', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.72', 'ciLowerLimit': '-107', 'ciUpperLimit': '99.4', 'estimateComment': 'Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 1:\n\nChange from baseline = study group + visit + study group\\*visit + subject +random error, fitted with unstructured covariance matrix', 'groupDescription': 'Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study in urinary total NNAL', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study in urinary total NNAL'}, {'pValue': '0.8264', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.2', 'ciLowerLimit': '-122', 'ciUpperLimit': '97.5', 'estimateComment': 'Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:\n\nChange from baseline= study group + visit + study group\\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix', 'groupDescription': 'Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in urinary total NNAL', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in urinary total NNAL'}], 'paramType': 'MEAN', 'timeFrame': 'Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)', 'description': 'Summary statistics of change from baseline for urinary total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol \\[NNAL\\] (ng/g creatinine) in each study visit are presented.\n\nBaseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1', 'unitOfMeasure': 'ng/g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population'}, {'type': 'SECONDARY', 'title': 'Summary Statistics of Change From Baseline for Nicotine Equivalents (mg / g Creatinine) (Per-Protocol Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (ad Libitum VBM-FG2)', 'description': 'Subjects were allowed to continue smoking their own brand of cigarettes ad libitum and were provided the option to use the test product (VBM-FG2 oral discs) also under ad libitum conditions'}, {'id': 'OG001', 'title': 'Control (no VBM-FG2)', 'description': 'Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks'}], 'classes': [{'title': 'Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '5.28', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '6.45', 'groupId': 'OG001'}]}]}, {'title': 'Visit 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '8.46', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '6.48', 'groupId': 'OG001'}]}]}, {'title': 'Visit 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '8.03', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '9.47', 'groupId': 'OG001'}]}]}, {'title': 'End of Study/Early Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.6', 'spread': '9.75', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '6.89', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4903', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.13', 'ciLowerLimit': '-4.35', 'ciUpperLimit': '2.10', 'estimateComment': 'Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 1:\n\nChange from baseline = study group + visit + study group\\*visit + subject +random error, fitted with unstructured covariance matrix', 'groupDescription': 'Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in nicotine equivalents', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in nicotine equivalents'}, {'pValue': '0.4251', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.40', 'ciLowerLimit': '-4.88', 'ciUpperLimit': '2.07', 'estimateComment': 'Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:\n\nChange from baseline= study group + visit + study group\\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix', 'groupDescription': 'Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in nicotine equivalents', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in nicotine equivalents'}], 'paramType': 'MEAN', 'timeFrame': 'Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)', 'description': "Summary statistics of change from Baseline for urinary nicotine equivalents including nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide) (mg/g creatinine) in each study visit are presented.\n\nBaseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1", 'unitOfMeasure': 'mg/g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population'}, {'type': 'SECONDARY', 'title': 'Summary Statistics of Percent Change From Baseline for Nicotine Equivalents (%) (Per-Protocol Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (ad Libitum VBM-FG2)', 'description': 'Subjects were allowed to continue smoking their own brand of cigarettes ad libitum and were provided the option to use the test product (VBM-FG2 oral discs) also under ad libitum conditions'}, {'id': 'OG001', 'title': 'Control (no VBM-FG2)', 'description': 'Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks'}], 'classes': [{'title': 'Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '37.85', 'groupId': 'OG000'}, {'value': '14.8', 'spread': '51.81', 'groupId': 'OG001'}]}]}, {'title': 'Visit 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.7', 'spread': '57.95', 'groupId': 'OG000'}, {'value': '26.3', 'spread': '50.78', 'groupId': 'OG001'}]}]}, {'title': 'Visit 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.7', 'spread': '54.02', 'groupId': 'OG000'}, {'value': '30.8', 'spread': '53.08', 'groupId': 'OG001'}]}]}, {'title': 'End of Study/Early Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.2', 'spread': '65.08', 'groupId': 'OG000'}, {'value': '35.5', 'spread': '60.54', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4060', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.83', 'ciLowerLimit': '-33.2', 'ciUpperLimit': '13.5', 'estimateComment': 'Difference in Least Square means (Test - Control) using Mixed Effects Repeated Measures Model 1:\n\nPercent Change from baseline = study group + visit + study group\\*visit + subject + random error, fitted with unstructured covariance matrix.', 'groupDescription': 'Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in nicotine equivalents', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in nicotine equivalents'}, {'pValue': '0.4165', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.3', 'ciLowerLimit': '-35.4', 'ciUpperLimit': '14.7', 'estimateComment': 'Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:\n\n%Change from baseline = study group +visit +study group\\*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix.', 'groupDescription': 'Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in nicotine equivalents', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in nicotine equivalents'}], 'paramType': 'MEAN', 'timeFrame': 'Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)', 'description': "Summary statistics of percent change from Baseline for urinary nicotine equivalents including nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide) (%) in each study visit are presented.\n\nBaseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1\n\nMean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a SAS® procedure.", 'unitOfMeasure': 'percent change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population'}, {'type': 'SECONDARY', 'title': 'Summary Statistics of Change From Baseline for S-phenyl Mercapturic Acid (S-PMA) (ng/g Creatinine) (Per-Protocol Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (ad Libitum VBM-FG2)', 'description': 'Subjects were allowed to continue smoking their own brand of cigarettes ad libitum and were provided the option to use the test product (VBM-FG2 oral discs) also under ad libitum conditions'}, {'id': 'OG001', 'title': 'Control (no VBM-FG2)', 'description': 'Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks'}], 'classes': [{'title': 'Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '506.33', 'spread': '3150.049', 'groupId': 'OG000'}, {'value': '242.66', 'spread': '2846.817', 'groupId': 'OG001'}]}]}, {'title': 'Visit 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1129.88', 'spread': '4867.996', 'groupId': 'OG000'}, {'value': '809.04', 'spread': '3649.614', 'groupId': 'OG001'}]}]}, {'title': 'Visit 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1102.42', 'spread': '4045.946', 'groupId': 'OG000'}, {'value': '1637.29', 'spread': '4348.050', 'groupId': 'OG001'}]}]}, {'title': 'End of Study/Early Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '903.49', 'spread': '4985.072', 'groupId': 'OG000'}, {'value': '1160.48', 'spread': '2798.644', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7240', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-269', 'ciLowerLimit': '-1773', 'ciUpperLimit': '1235', 'estimateComment': 'Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 1:\n\nChange from baseline = study group + visit + study group\\*visit + subject +random error, fitted with unstructured covariance matrix', 'groupDescription': 'Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in S-PMA', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in S-PMA'}, {'pValue': '0.9508', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '50.5', 'ciLowerLimit': '-1566', 'ciUpperLimit': '1667', 'estimateComment': 'Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:\n\nChange from baseline= study group + visit + study group\\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix', 'groupDescription': 'Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in S-PMA', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in S-PMA'}], 'paramType': 'MEAN', 'timeFrame': 'Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)', 'description': 'Summary statistics of change from Baseline for urinary S-phenyl mercapturic acid \\[S-PMA\\] (ng/g creatinine) in each study visit are presented.\n\nBaseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1', 'unitOfMeasure': 'ng/g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population'}, {'type': 'SECONDARY', 'title': 'Summary Statistics of Percent Change From Baseline for S-PMA (%) (Per-Protocol Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (ad Libitum VBM-FG2)', 'description': 'Subjects were allowed to continue smoking their own brand of cigarettes ad libitum and were provided the option to use the test product (VBM-FG2 oral discs) also under ad libitum conditions'}, {'id': 'OG001', 'title': 'Control (no VBM-FG2)', 'description': 'Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks'}], 'classes': [{'title': 'Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.5', 'spread': '67.39', 'groupId': 'OG000'}, {'value': '21.1', 'spread': '77.37', 'groupId': 'OG001'}]}]}, {'title': 'Visit 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.4', 'spread': '67.41', 'groupId': 'OG000'}, {'value': '38.2', 'spread': '69.68', 'groupId': 'OG001'}]}]}, {'title': 'Visit 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.7', 'spread': '60.60', 'groupId': 'OG000'}, {'value': '44.4', 'spread': '87.87', 'groupId': 'OG001'}]}]}, {'title': 'End of Study/Early Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.9', 'spread': '76.27', 'groupId': 'OG000'}, {'value': '39.1', 'spread': '70.93', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1524', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.0', 'ciLowerLimit': '-45.1', 'ciUpperLimit': '7.12', 'estimateComment': 'Difference in Least Square means (Test - Control) using Mixed Effects Repeated Measures Model 1:\n\nPercent Change from baseline = study group + visit + study group\\*visit + subject + random error, fitted with unstructured covariance matrix.', 'groupDescription': 'Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in S-PMA', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in S-PMA'}, {'pValue': '0.4014', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.1', 'ciLowerLimit': '-40.4', 'ciUpperLimit': '16.3', 'estimateComment': 'Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:\n\n%Change from baseline = study group +visit +study group\\*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix.', 'groupDescription': 'Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in S-PMA', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in S-PMA'}], 'paramType': 'MEAN', 'timeFrame': 'Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)', 'description': "Summary statistics of percent change from Baseline for urinary S-phenyl mercapturic acid \\[S-PMA\\] (%) in each study visit are presented.\n\nBaseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1\n\nMean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a SAS® procedure.", 'unitOfMeasure': 'percent change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population'}, {'type': 'SECONDARY', 'title': 'Summary Statistics of Change From Baseline for Carboxyhemoglobin (%) (Per-Protocol Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (ad Libitum VBM-FG2)', 'description': 'Subjects were allowed to continue smoking their own brand of cigarettes ad libitum and were provided the option to use the test product (VBM-FG2 oral discs) also under ad libitum conditions'}, {'id': 'OG001', 'title': 'Control (no VBM-FG2)', 'description': 'Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks'}], 'classes': [{'title': 'Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.42', 'spread': '1.449', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '1.460', 'groupId': 'OG001'}]}]}, {'title': 'Visit 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.24', 'spread': '1.418', 'groupId': 'OG000'}, {'value': '0.39', 'spread': '1.374', 'groupId': 'OG001'}]}]}, {'title': 'Visit 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.02', 'spread': '1.547', 'groupId': 'OG000'}, {'value': '0.39', 'spread': '1.299', 'groupId': 'OG001'}]}]}, {'title': 'End of Study/Early Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.61', 'spread': '1.387', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '1.118', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0241', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.507', 'ciLowerLimit': '-0.946', 'ciUpperLimit': '-0.0674', 'estimateComment': 'Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 1:\n\nChange from baseline = study group + visit + study group\\*visit + subject +random error, fitted with unstructured covariance matrix', 'groupDescription': 'Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in carboxyhemoglobin', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in carboxyhemoglobin'}, {'pValue': '0.1292', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.367', 'ciLowerLimit': '-0.843', 'ciUpperLimit': '0.108', 'estimateComment': 'Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:\n\nChange from baseline= study group + visit + study group\\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix', 'groupDescription': 'Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in carboxyhemoglobin', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in carboxyhemoglobin'}], 'paramType': 'MEAN', 'timeFrame': 'Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)', 'description': 'Summary statistics of change from Baseline for blood carboxyhemoglobin (%) in each study visit are presented.\n\nBaseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1', 'unitOfMeasure': 'percent saturation of carboxyhemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population'}, {'type': 'SECONDARY', 'title': 'Summary Statistics of Percent Change From Baseline for Carboxyhemoglobin (%) (Per-Protocol Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (ad Libitum VBM-FG2)', 'description': 'Subjects were allowed to continue smoking their own brand of cigarettes ad libitum and were provided the option to use the test product (VBM-FG2 oral discs) also under ad libitum conditions'}, {'id': 'OG001', 'title': 'Control (no VBM-FG2)', 'description': 'Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks'}], 'classes': [{'title': 'Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.3', 'spread': '27.48', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '35.59', 'groupId': 'OG001'}]}]}, {'title': 'Visit 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.0', 'spread': '26.17', 'groupId': 'OG000'}, {'value': '9.8', 'spread': '27.21', 'groupId': 'OG001'}]}]}, {'title': 'Visit 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '28.26', 'groupId': 'OG000'}, {'value': '11.3', 'spread': '29.44', 'groupId': 'OG001'}]}]}, {'title': 'End of Study/Early Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.3', 'spread': '27.89', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '25.53', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0333', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.0', 'ciLowerLimit': '-19.2', 'ciUpperLimit': '-0.803', 'estimateComment': 'Difference in Least Square means (Test - Control) using Mixed Effects Repeated Measures Model 1:\n\nPercent Change from baseline = study group + visit + study group\\*visit + subject + random error, fitted with unstructured covariance matrix.', 'groupDescription': 'Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin'}, {'pValue': '0.1767', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.76', 'ciLowerLimit': '-16.6', 'ciUpperLimit': '3.08', 'estimateComment': 'Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:\n\n%Change from baseline = study group +visit +study group\\*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix.', 'groupDescription': 'Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin'}], 'paramType': 'MEAN', 'timeFrame': 'Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)', 'description': "Summary statistics of percent change from Baseline for blood carboxyhemoglobin (%) in each study visit are presented.\n\nBaseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1\n\nMean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a SAS® procedure.", 'unitOfMeasure': 'percent change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population'}, {'type': 'SECONDARY', 'title': 'Summary Statistics of Change From Baseline for Exhaled Carbon Monoxide (Ppm) (Per-Protocol Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (ad Libitum VBM-FG2)', 'description': 'Subjects were allowed to continue smoking their own brand of cigarettes ad libitum and were provided the option to use the test product (VBM-FG2 oral discs) also under ad libitum conditions'}, {'id': 'OG001', 'title': 'Control (no VBM-FG2)', 'description': 'Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks'}], 'classes': [{'title': 'Visit 4', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '9.41', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '7.84', 'groupId': 'OG001'}]}]}, {'title': 'Visit 5', 'categories': [{'measurements': [{'value': '-1.9', 'spread': '7.48', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '8.37', 'groupId': 'OG001'}]}]}, {'title': 'Visit 6', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '9.30', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '7.89', 'groupId': 'OG001'}]}]}, {'title': 'End of Study/Early Termination', 'categories': [{'measurements': [{'value': '-2.3', 'spread': '9.17', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '6.90', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2961', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.51', 'ciLowerLimit': '-4.36', 'ciUpperLimit': '1.34', 'estimateComment': 'Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 1:\n\nChange from baseline = study group + visit + study group\\*visit + subject +random error, fitted with unstructured covariance matrix', 'groupDescription': 'Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in exhaled carbon monoxide', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in exhaled carbon monoxide'}, {'pValue': '0.5015', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.05', 'ciLowerLimit': '-4.12', 'ciUpperLimit': '2.03', 'estimateComment': 'Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:\n\nChange from baseline= study group + visit + study group\\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix', 'groupDescription': 'Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in exhaled carbon monoxide', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in exhaled carbon monoxide'}], 'paramType': 'MEAN', 'timeFrame': 'Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)', 'description': 'Summary statistics of change from Baseline for exhaled carbon monoxide (ppm) in each study visit are presented.\n\nBaseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1', 'unitOfMeasure': 'ppm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population'}, {'type': 'SECONDARY', 'title': 'Summary Statistics of Percent Change From Baseline for Exhaled Carbon Monoxide (%) (Per-Protocol Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (ad Libitum VBM-FG2)', 'description': 'Subjects were allowed to continue smoking their own brand of cigarettes ad libitum and were provided the option to use the test product (VBM-FG2 oral discs) also under ad libitum conditions'}, {'id': 'OG001', 'title': 'Control (no VBM-FG2)', 'description': 'Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks'}], 'classes': [{'title': 'Visit 4', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '44.65', 'groupId': 'OG000'}, {'value': '12.0', 'spread': '65.86', 'groupId': 'OG001'}]}]}, {'title': 'Visit 5', 'categories': [{'measurements': [{'value': '-5.8', 'spread': '37.05', 'groupId': 'OG000'}, {'value': '11.4', 'spread': '54.87', 'groupId': 'OG001'}]}]}, {'title': 'Visit 6', 'categories': [{'measurements': [{'value': '3.5', 'spread': '49.07', 'groupId': 'OG000'}, {'value': '13.9', 'spread': '57.42', 'groupId': 'OG001'}]}]}, {'title': 'End of Study/Early Termination', 'categories': [{'measurements': [{'value': '-3.1', 'spread': '47.00', 'groupId': 'OG000'}, {'value': '9.0', 'spread': '66.04', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2048', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.1', 'ciLowerLimit': '-30.9', 'ciUpperLimit': '6.68', 'estimateComment': 'Difference in Least Square means (Test - Control) using Mixed Effects Repeated Measures Model 1:\n\nPercent Change from baseline = study group + visit + study group\\*visit + subject + random error, fitted with unstructured covariance matrix.', 'groupDescription': 'Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in exhaled carbon monoxide', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in exhaled carbon monoxide'}, {'pValue': '0.4731', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.32', 'ciLowerLimit': '-27.4', 'ciUpperLimit': '12.8', 'estimateComment': 'Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:\n\n%Change from baseline = study group +visit +study group\\*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix.', 'groupDescription': 'Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to control in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to control in exhaled carbon monoxide', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to control in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to control in exhaled carbon monoxide'}], 'paramType': 'MEAN', 'timeFrame': 'Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)', 'description': "Summary statistics of percent change from Baseline for exhaled carbon monoxide (%) in each study visit are presented.\n\nBaseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1\n\nMean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a SAS® procedure.", 'unitOfMeasure': 'percent change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population'}, {'type': 'SECONDARY', 'title': 'Summary Statistics of Change From Baseline in Cigarettes Smoked Per Day (Per-Protocol Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (ad Libitum VBM-FG2)', 'description': 'Subjects were allowed to continue smoking their own brand of cigarettes ad libitum and were provided the option to use the test product (VBM-FG2 oral discs) also under ad libitum conditions'}, {'id': 'OG001', 'title': 'Control (no VBM-FG2)', 'description': 'Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks'}], 'classes': [{'title': 'Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.7', 'spread': '3.28', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.96', 'groupId': 'OG001'}]}]}, {'title': 'Visit 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'spread': '4.34', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '2.37', 'groupId': 'OG001'}]}]}, {'title': 'Visit 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '4.41', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '2.78', 'groupId': 'OG001'}]}]}, {'title': 'End of Study/Early Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.5', 'spread': '4.78', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '2.76', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.86', 'ciLowerLimit': '-5.25', 'ciUpperLimit': '-2.47', 'estimateComment': 'Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 1:\n\nChange from baseline = study group + visit + study group\\*visit + subject +random error, fitted with unstructured covariance matrix', 'groupDescription': 'Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in cigarettes smoked per day', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in cigarettes smoked per day'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.74', 'ciLowerLimit': '-5.14', 'ciUpperLimit': '-2.34', 'estimateComment': 'Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:\n\nChange from baseline= study group + visit + study group\\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix', 'groupDescription': 'Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in cigarettes smoked per day', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in cigarettes smoked per day'}], 'paramType': 'MEAN', 'timeFrame': 'Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)', 'description': 'Summary statistics of change from Baseline in number or products used day in each study visit are presented.\n\nValues for visit are the average of daily values for the previous week Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1', 'unitOfMeasure': 'cigarettes per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population'}, {'type': 'SECONDARY', 'title': 'Summary Statistics of Percent Change From Baseline for Cigarettes Smoked Per Day (CPD) (Per-Protocol Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (ad Libitum VBM-FG2)', 'description': 'Subjects were allowed to continue smoking their own brand of cigarettes ad libitum and were provided the option to use the test product (VBM-FG2 oral discs) also under ad libitum conditions'}, {'id': 'OG001', 'title': 'Control (no VBM-FG2)', 'description': 'Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks'}], 'classes': [{'title': 'Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-15.0', 'spread': '19.30', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '10.85', 'groupId': 'OG001'}]}]}, {'title': 'Visit 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-16.5', 'spread': '26.21', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '15.18', 'groupId': 'OG001'}]}]}, {'title': 'Visit 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-16.3', 'spread': '24.78', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '18.01', 'groupId': 'OG001'}]}]}, {'title': 'End of Study/Early Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-19.2', 'spread': '27.03', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '17.28', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-22.5', 'ciLowerLimit': '-30.5', 'ciUpperLimit': '-14.5', 'estimateComment': 'Difference in Least Square means (Test - Control) using Mixed Effects Repeated Measures Model 1:\n\nPercent Change from baseline = study group + visit + study group\\*visit + subject + random error, fitted with unstructured covariance matrix.', 'groupDescription': 'Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-22.3', 'ciLowerLimit': '-30.4', 'ciUpperLimit': '-14.1', 'estimateComment': 'Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:\n\n%Change from baseline = study group +visit +study group\\*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix.', 'groupDescription': 'Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day'}], 'paramType': 'MEAN', 'timeFrame': 'Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)', 'description': "Summary statistics of percent change from Baseline of number of products used per day in each study visit are presented.\n\nCPD was tracked using an interactive voice response system (IVRS). During the Baseline Period (Days 1 to 8), subjects reported CPD daily through an IVRS each day between 16:00 and 19:00. Test and Control subjects continued daily tobacco use tracking via an IVRS and return to the study site once a week during the 4 week Product Use Period on Days 15, 22, 29, and 36.\n\nMean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing the calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a SAS procedure.", 'unitOfMeasure': 'percent change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population'}, {'type': 'SECONDARY', 'title': 'Summary Statistics of Change From Baseline for Total Score of Fagerstrom Test for Cigarette Dependence (Per-Protocol Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (ad Libitum VBM-FG2)', 'description': 'Subjects were allowed to continue smoking their own brand of cigarettes ad libitum and were provided the option to use the test product (VBM-FG2 oral discs) also under ad libitum conditions'}, {'id': 'OG001', 'title': 'Control (no VBM-FG2)', 'description': 'Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.66', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.82', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0919', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.408', 'ciLowerLimit': '-0.884', 'ciUpperLimit': '0.0673', 'estimateComment': 'Difference in LS mean change between study groups using Mixed Effects Repeated Measures Model 1:\n\nChange from baseline=study group + visit + study group\\*visit + subject + random error, fitted with unstructured covariance matrix', 'groupDescription': 'Null hypothesis = Test and Control groups will have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Null hypothesis = Test and Control groups will have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence'}, {'pValue': '0.0975', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.405', 'ciLowerLimit': '-0.886', 'ciUpperLimit': '0.0751', 'estimateComment': 'Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:\n\nChange from baseline= study group + visit + study group\\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix', 'groupDescription': 'Null hypothesis = Test and Control groups will have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Null hypothesis = Test and Control groups will have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence'}, {'pValue': '0.0643', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.31', 'ciLowerLimit': '-17.1', 'ciUpperLimit': '0.499', 'estimateComment': 'Difference in LS mean percent change between study groups using Mixed Effects Repeated Measures Model 1:\n\nChange from baseline=study group + visit + study group\\*visit + subject + random error, fitted with unstructured covariance matrix', 'groupDescription': 'Statistical Analysis of Difference in Percent Change from Baseline in Total Score of Fagerstrom Test for Cigarette Dependence between the Study Groups.\n\nNull hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Statistical Analysis of Difference in Percent Change from Baseline in Total Score of Fagerstrom Test for Cigarette Dependence between the Study Groups.\n\nNull hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence'}, {'pValue': '0.0517', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.84', 'ciLowerLimit': '-17.7', 'ciUpperLimit': '0.0661', 'estimateComment': 'Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:\n\nChange from baseline= study group + visit + study group\\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix', 'groupDescription': 'Statistical Analysis of Difference in Percent Change from Baseline in Total Score of Fagerstrom Test for Cigarette Dependence between the Study Groups.\n\nNull hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Statistical Analysis of Difference in Percent Change from Baseline in Total Score of Fagerstrom Test for Cigarette Dependence between the Study Groups.\n\nNull hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence'}], 'paramType': 'MEAN', 'timeFrame': 'Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)', 'description': "Summary statistics of change from Baseline for Total Score of Fagerstrom Test for Cigarette Dependence at the end of study/early termination are presented. The Fagerstrom Test for Nicotine Dependence consists of Yes/No and multiple-choice questions where each response is assigned a value from 0 to 1 (for yes/no questions) or 0 to 3 (for multiple-choice questions). Values are summed to yield a total score with a minimum score of 0 points and a maximum score of 10 points. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine.\n\nBaseline = Visit 3 (Day 8) value Population: Per-Protocol", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population'}, {'type': 'SECONDARY', 'title': 'Count of Subjects in Subgroups Based on Change From Baseline to End of Study on Change in Quit Attempts (Per-Protocol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (ad Libitum VBM-FG2)', 'description': 'Subjects were allowed to continue smoking their own brand of cigarettes ad libitum and were provided the option to use the test product (VBM-FG2 oral discs) also under ad libitum conditions'}, {'id': 'OG001', 'title': 'Control (no VBM-FG2)', 'description': 'Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks'}], 'classes': [{'title': 'Increase', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'Decrease', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2160', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Probability', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.2160', 'estimateComment': 'Estimated value is the probability of observed distribution assuming the null hypothesis', 'groupDescription': 'Null hypothesis = Test and Control groups will have equivalent levels of change in quit attempts from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quit attempts from baseline to end of study', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Null hypothesis = Test and Control groups will have equivalent levels of change in quit attempts from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quit attempts from baseline to end of study'}, {'pValue': '0.0648', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Probability', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.0648', 'groupDescription': 'Null hypothesis = Test and Control groups will have equivalent levels of change in quit attempts from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quit attempts from baseline to end of study', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Null hypothesis = Test and Control groups will have equivalent levels of change in quit attempts from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quit attempts from baseline to end of study'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)', 'description': 'Count of Test and Control subjects that reported an increase, decrease or no change in quit attempts from Baseline to End of Study are presented. Results for the number of self-reported attempts to quit smoking in the previous 30 days were collected from subject responses to the question "How many times during the past 30 days have you stopped smoking cigarettes for 24 hours or longer because you were trying to quit?".\n\nBaseline = Visit 2 values. Population: Per-Protocol.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population'}, {'type': 'SECONDARY', 'title': 'Count of Subjects in Subgroups Based on Change From Baseline to End of Study on Change in Quitting Intentions (Per-Protocol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (ad Libitum VBM-FG2)', 'description': 'Subjects were allowed to continue smoking their own brand of cigarettes ad libitum and were provided the option to use the test product (VBM-FG2 oral discs) also under ad libitum conditions'}, {'id': 'OG001', 'title': 'Control (no VBM-FG2)', 'description': 'Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks'}], 'classes': [{'title': 'No to Yes', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Same', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5977', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Probability', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.5977', 'estimateComment': 'Estimated value is the probability of observed distribution assuming the null hypothesis', 'groupDescription': 'Null hypothesis = Test and Control groups will have equivalent levels of change in quitting intentions from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quitting intentions from baseline to end of study', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Null hypothesis = Test and Control groups will have equivalent levels of change in quitting intentions from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quitting intentions from baseline to end of study'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)', 'description': 'Count of Test and Control subjects that reported a change (No to Yes) or no change in quitting intentions from Baseline to End of Study are presented. Results were collected from subject Yes/No responses to the question "Are you planning to quit smoking in the next 30 days?".\n\nBaseline = Visit 2 responses. Population: Per-Protocol.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population'}, {'type': 'SECONDARY', 'title': 'Difference in Means of Urinary Total NNAL Exposure Between Day 1 and Day 8 (Per-Protocol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 1 (Weekly Recall)', 'description': 'Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1)'}, {'id': 'OG001', 'title': 'Day 8 (Daily Tracking Using IVRS)', 'description': 'Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8).'}], 'classes': [{'categories': [{'measurements': [{'value': '485.0', 'spread': '348.45', 'groupId': 'OG000'}, {'value': '495.0', 'spread': '358.54', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4388', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.0', 'ciLowerLimit': '-15.5', 'ciUpperLimit': '35.5', 'groupDescription': 'Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of NNAL; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of NNAL', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of NNAL; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of NNAL'}], 'paramType': 'MEAN', 'timeFrame': 'Daily during Baseline Period (Day 1 to Day 8)', 'description': 'This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period.\n\nDifference in mean urinary total NNAL exposure between two methods for determining daily product use (Cigarettes Per Day \\[CPD\\]) during the Baseline Period:\n\nMethod 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1).\n\nMethod 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8).\n\nPopulation: Per-Protocol.', 'unitOfMeasure': 'ng/g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The CPD from Method 1 (Past 7 Day Cigarettes Use Questionnaire) for all subjects in the Per-Protocol population was compared to CPD from Method 2 (7 day average from IVRS) for all subjects in the Per-Protocol population.'}, {'type': 'SECONDARY', 'title': 'Difference in Means of Nicotine Equivalents Exposure Between Day 1 and Day 8 (Per-Protocol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 1 (Weekly Recall)', 'description': 'Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1)'}, {'id': 'OG001', 'title': 'Day 8 (Daily Tracking Using IVRS)', 'description': 'Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8).'}], 'classes': [{'categories': [{'measurements': [{'value': '13.29', 'spread': '9.138', 'groupId': 'OG000'}, {'value': '13.74', 'spread': '9.049', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3390', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.45', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '1.38', 'groupDescription': 'Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of nicotine metabolites; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of nicotine metabolites', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of nicotine metabolites; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of nicotine metabolites'}], 'paramType': 'MEAN', 'timeFrame': 'Daily during Baseline Period (Day 1 to Day 8)', 'description': "This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period.\n\nDifference in mean urinary nicotine equivalents exposure between two methods for determining daily product use (Cigarettes Per Day \\[CPD\\]) during the Baseline Period:\n\nMethod 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1).\n\nMethod 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8).\n\nNicotine equivalents include nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide) Population: Per-Protocol.", 'unitOfMeasure': 'mg/g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The CPD from Method 1 (Past 7 Day Cigarettes Use Questionnaire) for all subjects in the Per-Protocol population was compared to CPD from Method 2 (7 day average from IVRS) for all subjects in the Per-Protocol population.'}, {'type': 'SECONDARY', 'title': 'Difference in Means of S-PMA Exposure Between Day 1 and Day 8 (Per-Protocol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 1 (Weekly Recall)', 'description': 'Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1)'}, {'id': 'OG001', 'title': 'Day 8 (Daily Tracking Using IVRS)', 'description': 'Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8).'}], 'classes': [{'categories': [{'measurements': [{'value': '5773', 'spread': '5786.3', 'groupId': 'OG000'}, {'value': '5567', 'spread': '5222.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4526', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-205', 'ciLowerLimit': '-745', 'ciUpperLimit': '334', 'groupDescription': 'Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of S-PMA; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of S-PMA', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of S-PMA; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of S-PMA'}], 'paramType': 'MEAN', 'timeFrame': 'Daily during Baseline Period (Day 1 to Day 8)', 'description': 'This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period.\n\nDifference in mean urinary S-phenylmercapturic acid \\[S-PMA\\] exposure between two methods for determining daily product use (Cigarettes Per Day \\[CPD\\]) during the Baseline Period:\n\nMethod 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1).\n\nMethod 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8).\n\nPopulation: Per-Protocol.', 'unitOfMeasure': 'ng/g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The CPD from Method 1 (Past 7 Day Cigarettes Use Questionnaire) for all subjects in the Per-Protocol population was compared to CPD from Method 2 (7 day average from IVRS) for all subjects in the Per-Protocol population.'}, {'type': 'SECONDARY', 'title': 'Difference in Means of Carboxyhemoglobin (COHb) Exposure Between Day 1 and Day 8 (Per-Protocol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 1 (Weekly Recall)', 'description': 'Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1)'}, {'id': 'OG001', 'title': 'Day 8 (Daily Tracking Using IVRS)', 'description': 'Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8).'}], 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'spread': '2.13', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '1.96', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9440', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.2', 'groupDescription': 'Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of carboxyhemoglobin; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of carboxyhemoglobin', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of carboxyhemoglobin; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of carboxyhemoglobin'}], 'paramType': 'MEAN', 'timeFrame': 'Daily during Baseline Period (Day 1 to Day 8)', 'description': 'This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period.\n\nDifference in mean blood carboxyhemoglobin \\[COHb\\] exposure between two methods for determining daily product use (Cigarettes Per Day \\[CPD\\]) during the Baseline Period:\n\nMethod 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1).\n\nMethod 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8).\n\nPopulation: Per-Protocol.', 'unitOfMeasure': 'percent saturation of carboxyhemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The CPD from Method 1 (Past 7 Day Cigarettes Use Questionnaire) for all subjects in the Per-Protocol population was compared to CPD from Method 2 (7 day average from IVRS) for all subjects in the Per-Protocol population.'}, {'type': 'SECONDARY', 'title': 'Difference in Means of Carbon Monoxide (CO) Exposure Between Day 1 and Day 8 (Per-Protocol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 1 (Weekly Recall)', 'description': 'Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1)'}, {'id': 'OG001', 'title': 'Day 8 (Daily Tracking Using IVRS)', 'description': 'Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8).'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'spread': '10.0', 'groupId': 'OG000'}, {'value': '22', 'spread': '10.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7484', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-1', 'ciUpperLimit': '1', 'groupDescription': 'Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of carbon monoxide; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of carbon monoxide', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of carbon monoxide; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of carbon monoxide'}], 'paramType': 'MEAN', 'timeFrame': 'Daily during Baseline Period (Day 1 to Day 8)', 'description': 'This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period.\n\nDifference in mean exhaled carbon monoxide \\[CO\\] between two methods for determining daily product use (Cigarettes Per Day, CPD) during the Baseline Period:\n\nMethod 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1).\n\nMethod 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8).\n\nPopulation: Per-Protocol.', 'unitOfMeasure': 'ppm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The CPD from Method 1 (Past 7 Day Cigarettes Use Questionnaire) for all subjects in the Per-Protocol population was compared to CPD from Method 2 (7 day average from IVRS) for all subjects in the Per-Protocol population.'}, {'type': 'SECONDARY', 'title': 'Difference in Cigarettes Per Day Between the Once Weekly Recall at Day 8 (From Questionnaire) and the Average Daily Tracking Days 2 Through 8 (From IVRS) (Per-Protocol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 1 (Weekly Recall)', 'description': 'Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1)'}, {'id': 'OG001', 'title': 'Day 8 (Daily Tracking Using IVRS)', 'description': 'Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8).'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'spread': '6.4', 'groupId': 'OG000'}, {'value': '19', 'spread': '6.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9992', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '0', 'ciUpperLimit': '0', 'groupDescription': 'Null hypothesis = Cigarette consumption (CPD) determined using the Day 1 (Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will be equivalent; Alternate hypothesis = Cigarette consumption (CPD) determined using the Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT be equivalent', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Null hypothesis = Cigarette consumption (CPD) determined using the Day 1 (Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will be equivalent; Alternate hypothesis = Cigarette consumption (CPD) determined using the Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT be equivalent'}], 'paramType': 'MEAN', 'timeFrame': 'Daily during Baseline Period (Day 1 to Day 8)', 'description': 'This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period.\n\nDifference in product use (Cigarettes Per Day \\[CPD\\]), including test product, between two methods for determining CPD during the Baseline Period:\n\nMethod 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1).\n\nMethod 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8).\n\nPopulation: Per-Protocol.', 'unitOfMeasure': 'cigarettes per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The CPD from Method 1 (Past 7 Day Cigarettes Use Questionnaire) for all subjects in the Per-Protocol population was compared to CPD from Method 2 (7 day average from IVRS) for all subjects in the Per-Protocol population.'}, {'type': 'SECONDARY', 'title': 'Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '87', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}, {'value': '85', 'groupId': 'OG006'}, {'value': '55', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (Visit 4)', 'description': 'Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) cigarette consumption from Baseline to Visit 4'}, {'id': 'OG001', 'title': 'Control (Visit 4)', 'description': 'Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 4'}, {'id': 'OG002', 'title': 'Test (Visit 5)', 'description': 'Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) cigarette consumption from Baseline to Visit 5'}, {'id': 'OG003', 'title': 'Control (Visit 5)', 'description': 'Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 5'}, {'id': 'OG004', 'title': 'Test (Visit 6)', 'description': 'Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) cigarette consumption from Baseline to Visit 6'}, {'id': 'OG005', 'title': 'Control (Visit 6)', 'description': 'Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to Visit 6'}, {'id': 'OG006', 'title': 'Test (End of Study)', 'description': 'Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) cigarette consumption from Baseline to End of Study'}, {'id': 'OG007', 'title': 'Control (End of Study)', 'description': 'Change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) cigarette consumption from Baseline to End of Study'}], 'classes': [{'categories': [{'title': 'No Change', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}, {'title': '<50% Reduction', 'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '57', 'groupId': 'OG006'}, {'value': '24', 'groupId': 'OG007'}]}, {'title': '50% to < 100%', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}, {'title': '100% Reduction', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}, {'title': 'Increase', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7)', 'description': "Change in cigarette consumption, categorized as 'No change', '\\<50% reduction', '50% to \\< 100% reduction', '100% reduction' or 'Increase', among subjects in Test and Control groups are presented. Baseline values are based on the average of daily values for the week prior to randomization (Visit 3/Day 8±1).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population'}, {'type': 'SECONDARY', 'title': 'Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '87', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}, {'value': '87', 'groupId': 'OG006'}, {'value': '55', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (Visit 4)', 'description': 'Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) cigarette consumption from Baseline to Visit 4'}, {'id': 'OG001', 'title': 'Control (Visit 4)', 'description': 'Change in Control Group cigarette (subjects continued ad libitum use of their own brand of tobacco products) consumption from Baseline to Visit 4'}, {'id': 'OG002', 'title': 'Test (Visit 5)', 'description': 'Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) cigarette consumption from Baseline to Visit 5'}, {'id': 'OG003', 'title': 'Control (Visit 5)', 'description': 'Change in Control Group cigarette (subjects continued ad libitum use of their own brand of tobacco products) consumption from Baseline to Visit 5'}, {'id': 'OG004', 'title': 'Test (Visit 6)', 'description': 'Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) cigarette consumption from Baseline to Visit 6'}, {'id': 'OG005', 'title': 'Control (Visit 6)', 'description': 'Change in Control Group cigarette (subjects continued ad libitum use of their own brand of tobacco products) consumption from Baseline to Visit 6'}, {'id': 'OG006', 'title': 'Test (End of Study)', 'description': 'Change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) cigarette consumption from Baseline to End of Study'}, {'id': 'OG007', 'title': 'Control (End of Study)', 'description': 'Change in Control Group cigarette (subjects continued ad libitum use of their own brand of tobacco products) consumption from Baseline to End of Study'}], 'classes': [{'categories': [{'title': 'No Change', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}, {'title': 'Reduction', 'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}]}, {'title': 'Increase', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}, {'value': '46', 'groupId': 'OG006'}, {'value': '36', 'groupId': 'OG007'}]}, {'title': 'Missing', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7)', 'description': "Change in Urinary Total NNAL, categorized as 'No change', 'Reduction', 'Increase' or 'Missing', among subjects in Test and Control groups are presented. Baseline values are Visit 3 (Day 8) values.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population'}, {'type': 'SECONDARY', 'title': 'Frequency and Percentage of Subjects With Change From Baseline in Quitting Intentions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test', 'description': 'Subjects were allowed to continue smoking their own brand of cigarettes ad libitum and were provided the option to use the test product (VBM-FG2 oral discs) also under ad libitum conditions'}, {'id': 'OG001', 'title': 'Control', 'description': 'Subjects continued ad libitum use of their own brand of cigarettes and/or other tobacco products throughout the study but were not provided the test product (VBM-FG2 oral discs) for use in the study.'}], 'classes': [{'categories': [{'title': 'No to Yes', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Yes to No', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Same', 'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)', 'description': "Change in subject quitting intentions from Baseline to End of Study are presented. Subject responses were categorized as 'No to Yes', 'Yes to No' and 'Same' (no change in quitting intention). Baseline = Visit 2 (Day 1)", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population'}, {'type': 'SECONDARY', 'title': 'Summary Statistics of Cigarettes Smoked Per Day on Visits 2 (Day 1) and 3 (Day 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (Visit 2)', 'description': 'Summary statistics of CPD for Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) on Visit 2'}, {'id': 'OG001', 'title': 'Control (Visit 2)', 'description': 'Summary statistics of CPD for Control Group (subjects continued ad libitum use of their own brand of tobacco products) on Visit 2'}, {'id': 'OG002', 'title': 'Test (Visit 3)', 'description': 'Summary statistics of CPD for Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) on Visit 3'}, {'id': 'OG003', 'title': 'Control (Visit 3)', 'description': 'Summary statistics of CPD for Control Group (subjects continued ad libitum use of their own brand of tobacco products) on Visit 3'}], 'classes': [{'categories': [{'measurements': [{'value': '17.7', 'spread': '6.04', 'groupId': 'OG000'}, {'value': '19.8', 'spread': '7.64', 'groupId': 'OG001'}, {'value': '17.6', 'spread': '5.36', 'groupId': 'OG002'}, {'value': '20.0', 'spread': '7.43', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (Visit 2) and Day 8 (Visit 3)', 'description': 'Summary statistics of average cigarettes smoked per day \\[CPD\\] over previous 7 days collected from Cigarette Use questionnaire on Visit 2 (Day 1) and Visit 3 (Day 8) are presented.', 'unitOfMeasure': 'cigarettes per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population'}, {'type': 'SECONDARY', 'title': 'Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '87', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}, {'value': '86', 'groupId': 'OG006'}, {'value': '55', 'groupId': 'OG007'}, {'value': '87', 'groupId': 'OG008'}, {'value': '55', 'groupId': 'OG009'}, {'value': '87', 'groupId': 'OG010'}, {'value': '55', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (Visit 2)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) Visit 2'}, {'id': 'OG001', 'title': 'Control (Visit 2)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 2'}, {'id': 'OG002', 'title': 'Test (Visit 3)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) Visit 3'}, {'id': 'OG003', 'title': 'Control (Visit 3)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 3'}, {'id': 'OG004', 'title': 'Test (Visit 4)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) Visit 4'}, {'id': 'OG005', 'title': 'Control (Visit 4)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 4'}, {'id': 'OG006', 'title': 'Test (Visit 5)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) Visit 5'}, {'id': 'OG007', 'title': 'Control (Visit 5)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 5'}, {'id': 'OG008', 'title': 'Test (Visit 6)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) Visit 6'}, {'id': 'OG009', 'title': 'Control (Visit 6)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6'}, {'id': 'OG010', 'title': 'Test (End of Study)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) End of Study'}, {'id': 'OG011', 'title': 'Control (End of Study)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study'}], 'classes': [{'title': 'Increase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '29', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}, {'value': '11', 'groupId': 'OG008'}, {'value': '29', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}, {'value': '29', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '6.5', 'spread': '2.61', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '2.10', 'groupId': 'OG001'}, {'value': '6.6', 'spread': '2.15', 'groupId': 'OG002'}, {'value': '5.3', 'spread': '1.63', 'groupId': 'OG003'}, {'value': '6.2', 'spread': '2.15', 'groupId': 'OG004'}, {'value': '5.5', 'spread': '1.65', 'groupId': 'OG005'}, {'value': '6.8', 'spread': '2.46', 'groupId': 'OG006'}, {'value': '6.1', 'spread': '2.26', 'groupId': 'OG007'}, {'value': '6.6', 'spread': '2.15', 'groupId': 'OG008'}, {'value': '5.8', 'spread': '2.07', 'groupId': 'OG009'}, {'value': '6.0', 'spread': '1.80', 'groupId': 'OG010'}, {'value': '5.4', 'spread': '1.79', 'groupId': 'OG011'}]}]}, {'title': 'No Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '8', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '4.7', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '0.14', 'groupId': 'OG001'}, {'value': '5.7', 'spread': '2.15', 'groupId': 'OG002'}, {'value': '3.7', 'spread': '2.19', 'groupId': 'OG003'}, {'value': '5.2', 'spread': '1.73', 'groupId': 'OG004'}, {'value': '3.3', 'spread': '0.14', 'groupId': 'OG005'}, {'value': '5.2', 'spread': '1.76', 'groupId': 'OG006'}, {'value': '3.2', 'spread': '0.07', 'groupId': 'OG007'}, {'value': '4.9', 'spread': '1.42', 'groupId': 'OG008'}, {'value': '5.6', 'spread': '3.11', 'groupId': 'OG009'}, {'value': '5.0', 'spread': '1.28', 'groupId': 'OG010'}, {'value': '4.6', 'spread': '1.41', 'groupId': 'OG011'}]}]}, {'title': '<50% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}, {'value': '55', 'groupId': 'OG006'}, {'value': '24', 'groupId': 'OG007'}, {'value': '56', 'groupId': 'OG008'}, {'value': '24', 'groupId': 'OG009'}, {'value': '56', 'groupId': 'OG010'}, {'value': '24', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '5.5', 'spread': '2.01', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '2.35', 'groupId': 'OG001'}, {'value': '5.4', 'spread': '1.92', 'groupId': 'OG002'}, {'value': '5.0', 'spread': '2.18', 'groupId': 'OG003'}, {'value': '5.2', 'spread': '2.05', 'groupId': 'OG004'}, {'value': '4.8', 'spread': '2.15', 'groupId': 'OG005'}, {'value': '5.4', 'spread': '2.24', 'groupId': 'OG006'}, {'value': '5.0', 'spread': '2.08', 'groupId': 'OG007'}, {'value': '5.8', 'spread': '2.28', 'groupId': 'OG008'}, {'value': '5.1', 'spread': '1.82', 'groupId': 'OG009'}, {'value': '5.1', 'spread': '2.07', 'groupId': 'OG010'}, {'value': '4.6', 'spread': '1.85', 'groupId': 'OG011'}]}]}, {'title': '50% to < 100% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '8', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '5.0', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '2.16', 'groupId': 'OG002'}, {'value': '4.7', 'spread': '2.03', 'groupId': 'OG004'}, {'value': '4.4', 'spread': '1.98', 'groupId': 'OG006'}, {'value': '3.7', 'spread': '1.90', 'groupId': 'OG008'}, {'value': '3.2', 'spread': '1.87', 'groupId': 'OG010'}]}]}, {'title': '100% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '0.35', 'groupId': 'OG002'}, {'value': '2.0', 'spread': '0.64', 'groupId': 'OG004'}, {'value': '1.2', 'spread': '0.21', 'groupId': 'OG006'}, {'value': '1.2', 'spread': '0.00', 'groupId': 'OG008'}, {'value': '1.5', 'spread': '0.21', 'groupId': 'OG010'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '1.63', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '2.33', 'groupId': 'OG002'}, {'value': '2.2', 'spread': '0.14', 'groupId': 'OG004'}, {'value': '3.3', 'spread': '1.98', 'groupId': 'OG006'}, {'value': '4.1', 'spread': '1.91', 'groupId': 'OG008'}, {'value': '3.7', 'spread': '0.92', 'groupId': 'OG010'}]}]}, {'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '87', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}, {'value': '86', 'groupId': 'OG006'}, {'value': '55', 'groupId': 'OG007'}, {'value': '87', 'groupId': 'OG008'}, {'value': '55', 'groupId': 'OG009'}, {'value': '87', 'groupId': 'OG010'}, {'value': '55', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '5.4', 'spread': '2.11', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '2.18', 'groupId': 'OG001'}, {'value': '5.5', 'spread': '1.99', 'groupId': 'OG002'}, {'value': '5.1', 'spread': '1.90', 'groupId': 'OG003'}, {'value': '5.1', 'spread': '2.10', 'groupId': 'OG004'}, {'value': '5.1', 'spread': '1.91', 'groupId': 'OG005'}, {'value': '5.3', 'spread': '2.32', 'groupId': 'OG006'}, {'value': '5.5', 'spread': '2.23', 'groupId': 'OG007'}, {'value': '5.5', 'spread': '2.33', 'groupId': 'OG008'}, {'value': '5.5', 'spread': '1.98', 'groupId': 'OG009'}, {'value': '4.9', 'spread': '2.07', 'groupId': 'OG010'}, {'value': '5.0', 'spread': '1.82', 'groupId': 'OG011'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (Visit 2), Day 8 (Visit 3), Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7)', 'description': "Summary statistics of blood carboxyhemoglobin in each visit among subjects in Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \\>50% Reduction', '50 to \\<100% Reduction', '100% Reduction' and 'Missing') are presented.", 'unitOfMeasure': 'percent saturation of carboxyhemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results.'}, {'type': 'SECONDARY', 'title': 'Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '87', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}, {'value': '87', 'groupId': 'OG006'}, {'value': '55', 'groupId': 'OG007'}, {'value': '87', 'groupId': 'OG008'}, {'value': '55', 'groupId': 'OG009'}, {'value': '87', 'groupId': 'OG010'}, {'value': '55', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (Visit 2)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) Visit 2'}, {'id': 'OG001', 'title': 'Control (Visit 2)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 2'}, {'id': 'OG002', 'title': 'Test (Visit 3)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) Visit 3'}, {'id': 'OG003', 'title': 'Control (Visit 3)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 3'}, {'id': 'OG004', 'title': 'Test (Visit 4)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) Visit 4'}, {'id': 'OG005', 'title': 'Control (Visit 4)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 4'}, {'id': 'OG006', 'title': 'Test (Visit 5)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) Visit 5'}, {'id': 'OG007', 'title': 'Control (Visit 5)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 5'}, {'id': 'OG008', 'title': 'Test (Visit 6)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) Visit 6'}, {'id': 'OG009', 'title': 'Control (Visit 6)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6'}, {'id': 'OG010', 'title': 'Test (End of Study)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) End of Study'}, {'id': 'OG011', 'title': 'Control (End of Study)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study'}], 'classes': [{'title': 'Increase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '29', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}, {'value': '11', 'groupId': 'OG008'}, {'value': '29', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}, {'value': '29', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '28.3', 'spread': '11.13', 'groupId': 'OG000'}, {'value': '21.0', 'spread': '9.65', 'groupId': 'OG001'}, {'value': '29.6', 'spread': '12.12', 'groupId': 'OG002'}, {'value': '20.6', 'spread': '9.11', 'groupId': 'OG003'}, {'value': '28.5', 'spread': '15.29', 'groupId': 'OG004'}, {'value': '21.4', 'spread': '8.57', 'groupId': 'OG005'}, {'value': '28.1', 'spread': '13.60', 'groupId': 'OG006'}, {'value': '22.7', 'spread': '13.28', 'groupId': 'OG007'}, {'value': '27.8', 'spread': '12.32', 'groupId': 'OG008'}, {'value': '21.8', 'spread': '10.44', 'groupId': 'OG009'}, {'value': '25.9', 'spread': '8.86', 'groupId': 'OG010'}, {'value': '20.2', 'spread': '9.54', 'groupId': 'OG011'}]}]}, {'title': 'No Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '8', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '17.3', 'spread': '10.77', 'groupId': 'OG000'}, {'value': '15.5', 'spread': '3.54', 'groupId': 'OG001'}, {'value': '22.5', 'spread': '9.56', 'groupId': 'OG002'}, {'value': '11.5', 'spread': '10.61', 'groupId': 'OG003'}, {'value': '21.6', 'spread': '8.88', 'groupId': 'OG004'}, {'value': '12.0', 'spread': '4.24', 'groupId': 'OG005'}, {'value': '22.4', 'spread': '10.88', 'groupId': 'OG006'}, {'value': '11.5', 'spread': '2.12', 'groupId': 'OG007'}, {'value': '19.3', 'spread': '9.82', 'groupId': 'OG008'}, {'value': '18.0', 'spread': '9.90', 'groupId': 'OG009'}, {'value': '21.5', 'spread': '9.96', 'groupId': 'OG010'}, {'value': '18.5', 'spread': '2.12', 'groupId': 'OG011'}]}]}, {'title': '<50% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}, {'value': '56', 'groupId': 'OG006'}, {'value': '24', 'groupId': 'OG007'}, {'value': '56', 'groupId': 'OG008'}, {'value': '24', 'groupId': 'OG009'}, {'value': '56', 'groupId': 'OG010'}, {'value': '24', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '22.2', 'spread': '9.21', 'groupId': 'OG000'}, {'value': '22.3', 'spread': '10.87', 'groupId': 'OG001'}, {'value': '21.6', 'spread': '10.01', 'groupId': 'OG002'}, {'value': '21.0', 'spread': '11.13', 'groupId': 'OG003'}, {'value': '20.9', 'spread': '11.16', 'groupId': 'OG004'}, {'value': '19.4', 'spread': '10.89', 'groupId': 'OG005'}, {'value': '20.5', 'spread': '10.25', 'groupId': 'OG006'}, {'value': '19.9', 'spread': '9.98', 'groupId': 'OG007'}, {'value': '23.0', 'spread': '11.32', 'groupId': 'OG008'}, {'value': '20.4', 'spread': '9.24', 'groupId': 'OG009'}, {'value': '21.1', 'spread': '10.09', 'groupId': 'OG010'}, {'value': '19.1', 'spread': '8.71', 'groupId': 'OG011'}]}]}, {'title': '50% to < 100% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '8', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '19.3', 'spread': '12.14', 'groupId': 'OG000'}, {'value': '20.6', 'spread': '9.86', 'groupId': 'OG002'}, {'value': '18.0', 'spread': '8.83', 'groupId': 'OG004'}, {'value': '15.5', 'spread': '8.38', 'groupId': 'OG006'}, {'value': '12.1', 'spread': '8.54', 'groupId': 'OG008'}, {'value': '9.9', 'spread': '6.08', 'groupId': 'OG010'}]}]}, {'title': '100% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '20.0', 'spread': '5.66', 'groupId': 'OG000'}, {'value': '17.0', 'spread': '4.24', 'groupId': 'OG002'}, {'value': '4.5', 'spread': '0.71', 'groupId': 'OG004'}, {'value': '2.5', 'spread': '0.71', 'groupId': 'OG006'}, {'value': '5.5', 'spread': '2.12', 'groupId': 'OG008'}, {'value': '4.0', 'spread': '2.83', 'groupId': 'OG010'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '20.5', 'spread': '14.85', 'groupId': 'OG000'}, {'value': '18.5', 'spread': '16.26', 'groupId': 'OG002'}, {'value': '10.5', 'spread': '2.12', 'groupId': 'OG004'}, {'value': '9.5', 'spread': '6.36', 'groupId': 'OG006'}, {'value': '15.5', 'spread': '12.02', 'groupId': 'OG008'}, {'value': '13.0', 'spread': '8.49', 'groupId': 'OG010'}]}]}, {'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '87', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}, {'value': '87', 'groupId': 'OG006'}, {'value': '55', 'groupId': 'OG007'}, {'value': '87', 'groupId': 'OG008'}, {'value': '55', 'groupId': 'OG009'}, {'value': '87', 'groupId': 'OG010'}, {'value': '55', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '22.1', 'spread': '10.05', 'groupId': 'OG000'}, {'value': '21.4', 'spread': '10.03', 'groupId': 'OG001'}, {'value': '22.4', 'spread': '10.40', 'groupId': 'OG002'}, {'value': '20.4', 'spread': '10.05', 'groupId': 'OG003'}, {'value': '21.0', 'spread': '11.68', 'groupId': 'OG004'}, {'value': '20.2', 'spread': '9.62', 'groupId': 'OG005'}, {'value': '20.5', 'spread': '11.18', 'groupId': 'OG006'}, {'value': '21.1', 'spread': '11.81', 'groupId': 'OG007'}, {'value': '21.7', 'spread': '11.71', 'groupId': 'OG008'}, {'value': '21.0', 'spread': '9.77', 'groupId': 'OG009'}, {'value': '20.1', 'spread': '10.41', 'groupId': 'OG010'}, {'value': '19.7', 'spread': '8.94', 'groupId': 'OG011'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (Visit 2), Day 8 (Visit 3), Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7)', 'description': "Summary Statistics of exhaled carbon monoxide in each visit among subjects in Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \\>50% Reduction', '50 to \\<100% Reduction', '100% Reduction' and 'Missing') are presented.", 'unitOfMeasure': 'ppm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results.'}, {'type': 'SECONDARY', 'title': 'Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '80', 'groupId': 'OG004'}, {'value': '50', 'groupId': 'OG005'}, {'value': '84', 'groupId': 'OG006'}, {'value': '49', 'groupId': 'OG007'}, {'value': '77', 'groupId': 'OG008'}, {'value': '52', 'groupId': 'OG009'}, {'value': '83', 'groupId': 'OG010'}, {'value': '52', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (Visit 2)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) Visit 2'}, {'id': 'OG001', 'title': 'Control (Visit 2)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 2'}, {'id': 'OG002', 'title': 'Test (Visit 3)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) Visit 3'}, {'id': 'OG003', 'title': 'Control (Visit 3)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 3'}, {'id': 'OG004', 'title': 'Test (Visit 4)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) Visit 4'}, {'id': 'OG005', 'title': 'Control (Visit 4)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 4'}, {'id': 'OG006', 'title': 'Test (Visit 5)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) Visit 5'}, {'id': 'OG007', 'title': 'Control (Visit 5)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 5'}, {'id': 'OG008', 'title': 'Test (Visit 6)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) Visit 6'}, {'id': 'OG009', 'title': 'Control (Visit 6)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 6'}, {'id': 'OG010', 'title': 'Test (End of Study)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) End of Study'}, {'id': 'OG011', 'title': 'Control (End of Study)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study'}], 'classes': [{'title': 'Increase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '26', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}, {'value': '28', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}, {'value': '27', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '7331.62', 'spread': '6411.996', 'groupId': 'OG000'}, {'value': '5283.78', 'spread': '4744.807', 'groupId': 'OG001'}, {'value': '5731.61', 'spread': '5064.881', 'groupId': 'OG002'}, {'value': '4934.00', 'spread': '4812.350', 'groupId': 'OG003'}, {'value': '6793.00', 'spread': '6076.280', 'groupId': 'OG004'}, {'value': '5961.02', 'spread': '5470.426', 'groupId': 'OG005'}, {'value': '7572.53', 'spread': '9023.363', 'groupId': 'OG006'}, {'value': '6342.74', 'spread': '5917.203', 'groupId': 'OG007'}, {'value': '5863.90', 'spread': '5274.304', 'groupId': 'OG008'}, {'value': '7369.19', 'spread': '6552.358', 'groupId': 'OG009'}, {'value': '8389.80', 'spread': '6625.523', 'groupId': 'OG010'}, {'value': '6358.61', 'spread': '5253.083', 'groupId': 'OG011'}]}]}, {'title': 'No Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '5283.54', 'spread': '4043.599', 'groupId': 'OG000'}, {'value': '5743.41', 'spread': '2819.277', 'groupId': 'OG001'}, {'value': '4216.93', 'spread': '2660.723', 'groupId': 'OG002'}, {'value': '6930.38', 'spread': '5483.666', 'groupId': 'OG003'}, {'value': '6412.49', 'spread': '4323.454', 'groupId': 'OG004'}, {'value': '5649.83', 'spread': '1833.540', 'groupId': 'OG005'}, {'value': '6158.33', 'spread': '5186.584', 'groupId': 'OG006'}, {'value': '6108.42', 'spread': '1258.428', 'groupId': 'OG007'}, {'value': '8118.69', 'spread': '5998.806', 'groupId': 'OG008'}, {'value': '4683.26', 'spread': '7.859', 'groupId': 'OG009'}, {'value': '4352.99', 'spread': '3873.342', 'groupId': 'OG010'}, {'value': '8688.22', 'spread': '3272.243', 'groupId': 'OG011'}]}]}, {'title': '<50% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}, {'value': '55', 'groupId': 'OG006'}, {'value': '21', 'groupId': 'OG007'}, {'value': '50', 'groupId': 'OG008'}, {'value': '22', 'groupId': 'OG009'}, {'value': '56', 'groupId': 'OG010'}, {'value': '23', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '6422.25', 'spread': '6830.753', 'groupId': 'OG000'}, {'value': '5449.38', 'spread': '5289.323', 'groupId': 'OG001'}, {'value': '6495.06', 'spread': '5936.803', 'groupId': 'OG002'}, {'value': '5356.63', 'spread': '5359.524', 'groupId': 'OG003'}, {'value': '6848.24', 'spread': '6467.601', 'groupId': 'OG004'}, {'value': '5315.31', 'spread': '6041.242', 'groupId': 'OG005'}, {'value': '7836.17', 'spread': '8644.447', 'groupId': 'OG006'}, {'value': '5399.55', 'spread': '4159.097', 'groupId': 'OG007'}, {'value': '8304.71', 'spread': '8562.548', 'groupId': 'OG008'}, {'value': '6567.55', 'spread': '7807.345', 'groupId': 'OG009'}, {'value': '7335.57', 'spread': '7068.643', 'groupId': 'OG010'}, {'value': '6481.35', 'spread': '6132.009', 'groupId': 'OG011'}]}]}, {'title': '50% to < 100% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '2925.07', 'spread': '3765.497', 'groupId': 'OG000'}, {'value': '5352.66', 'spread': '8413.472', 'groupId': 'OG002'}, {'value': '5151.19', 'spread': '6608.284', 'groupId': 'OG004'}, {'value': '4892.41', 'spread': '7615.700', 'groupId': 'OG006'}, {'value': '7230.42', 'spread': '9546.409', 'groupId': 'OG008'}, {'value': '9795.94', 'spread': '12602.08', 'groupId': 'OG010'}]}]}, {'title': '100% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '5647.56', 'spread': '1738.940', 'groupId': 'OG000'}, {'value': '5510.19', 'spread': '123.439', 'groupId': 'OG002'}, {'value': '2265.42', 'spread': '2731.172', 'groupId': 'OG004'}, {'value': '731.08', 'groupId': 'OG006'}, {'value': '533.76', 'spread': '461.885', 'groupId': 'OG008'}, {'value': '440.59', 'spread': '225.383', 'groupId': 'OG010'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '2389.46', 'spread': '964.418', 'groupId': 'OG000'}, {'value': '2693.13', 'spread': '1334.197', 'groupId': 'OG002'}, {'value': '2482.52', 'spread': '208.398', 'groupId': 'OG004'}, {'value': '2450.90', 'spread': '1729.041', 'groupId': 'OG006'}, {'value': '2144.28', 'spread': '1851.862', 'groupId': 'OG008'}, {'value': '2896.76', 'spread': '1518.588', 'groupId': 'OG010'}]}]}, {'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '80', 'groupId': 'OG004'}, {'value': '50', 'groupId': 'OG005'}, {'value': '84', 'groupId': 'OG006'}, {'value': '49', 'groupId': 'OG007'}, {'value': '77', 'groupId': 'OG008'}, {'value': '52', 'groupId': 'OG009'}, {'value': '83', 'groupId': 'OG010'}, {'value': '52', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '6072.78', 'spread': '6251.565', 'groupId': 'OG000'}, {'value': '5374.40', 'spread': '4875.645', 'groupId': 'OG001'}, {'value': '5991.56', 'spread': '5741.490', 'groupId': 'OG002'}, {'value': '5195.78', 'spread': '4999.201', 'groupId': 'OG003'}, {'value': '6431.69', 'spread': '6100.377', 'groupId': 'OG004'}, {'value': '5677.37', 'spread': '5562.787', 'groupId': 'OG005'}, {'value': '7151.83', 'spread': '8160.286', 'groupId': 'OG006'}, {'value': '5928.95', 'spread': '5068.858', 'groupId': 'OG007'}, {'value': '7525.25', 'spread': '7893.011', 'groupId': 'OG008'}, {'value': '6926.73', 'spread': '6941.824', 'groupId': 'OG009'}, {'value': '7098.86', 'spread': '7113.465', 'groupId': 'OG010'}, {'value': '6502.50', 'spread': '5540.461', 'groupId': 'OG011'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (Visit 2), Day 8 (Visit 3), Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7)', 'description': "Summary statistics of urinary S-PMA (ng/g creatinine) in each visit among subjects in Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \\>50% Reduction', '50 to \\<100% Reduction', '100% Reduction' and 'Missing') are presented.", 'unitOfMeasure': 'ng/g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results.'}, {'type': 'SECONDARY', 'title': 'Descriptive Statistics for Cigarettes Smoked Per Day (CPD) (Recall Data) in Day 1 and 8 (Respectively) by Study Group and Cigarette Consumption Categories', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (Visit 2)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) Visit 2 (Day 1)'}, {'id': 'OG001', 'title': 'Control (Visit 2)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 2 (Day 1)'}, {'id': 'OG002', 'title': 'Test (Visit 3)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) Visit 3 (Day 8)'}, {'id': 'OG003', 'title': 'Control (Visit 3)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 3 (Day 8)'}], 'classes': [{'title': 'Increase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.6', 'spread': '4.12', 'groupId': 'OG000'}, {'value': '19.7', 'spread': '8.52', 'groupId': 'OG001'}, {'value': '16.1', 'spread': '4.68', 'groupId': 'OG002'}, {'value': '19.9', 'spread': '8.47', 'groupId': 'OG003'}]}]}, {'title': 'No Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19.5', 'spread': '8.80', 'groupId': 'OG000'}, {'value': '20.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '17.6', 'spread': '8.28', 'groupId': 'OG002'}, {'value': '20.0', 'spread': '0.00', 'groupId': 'OG003'}]}]}, {'title': '<50% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18.4', 'spread': '5.97', 'groupId': 'OG000'}, {'value': '19.8', 'spread': '6.96', 'groupId': 'OG001'}, {'value': '18.2', 'spread': '4.94', 'groupId': 'OG002'}, {'value': '20.2', 'spread': '6.36', 'groupId': 'OG003'}]}]}, {'title': '50% to < 100% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16.0', 'spread': '6.54', 'groupId': 'OG000'}, {'value': '16.8', 'spread': '5.85', 'groupId': 'OG002'}]}]}, {'title': '100% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.5', 'spread': '3.54', 'groupId': 'OG000'}, {'value': '11.0', 'spread': '2.83', 'groupId': 'OG002'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.0', 'spread': '7.07', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG002'}]}]}, {'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17.7', 'spread': '6.04', 'groupId': 'OG000'}, {'value': '19.8', 'spread': '7.64', 'groupId': 'OG001'}, {'value': '17.6', 'spread': '5.36', 'groupId': 'OG002'}, {'value': '20.0', 'spread': '7.43', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (Visit 2) and Day 8 (Visit 3)', 'description': "Descriptive statistics for Cigarettes Smoked per Day (CPD) in Day 1 (Visit 2) and Day 8 (Visit 3) in Test and Control groups using recall data are presented. Subjects were sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \\>50% Reduction', '50 to \\<100% Reduction', '100% Reduction' and 'Missing').", 'unitOfMeasure': 'cigarettes per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results.'}, {'type': 'SECONDARY', 'title': 'Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '69', 'groupId': 'OG004'}, {'value': '47', 'groupId': 'OG005'}, {'value': '72', 'groupId': 'OG006'}, {'value': '44', 'groupId': 'OG007'}, {'value': '68', 'groupId': 'OG008'}, {'value': '43', 'groupId': 'OG009'}, {'value': '67', 'groupId': 'OG010'}, {'value': '49', 'groupId': 'OG011'}, {'value': '76', 'groupId': 'OG012'}, {'value': '42', 'groupId': 'OG013'}, {'value': '87', 'groupId': 'OG014'}, {'value': '55', 'groupId': 'OG015'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (Day 1)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) Day 1'}, {'id': 'OG001', 'title': 'Control (Day 1)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 1'}, {'id': 'OG002', 'title': 'Test (Day 2)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) Day 2'}, {'id': 'OG003', 'title': 'Control (Day 2)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 2'}, {'id': 'OG004', 'title': 'Test (Day 3)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) Day 3'}, {'id': 'OG005', 'title': 'Control (Day 3)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 3'}, {'id': 'OG006', 'title': 'Test (Day 4)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) Day 4'}, {'id': 'OG007', 'title': 'Control (Day 4)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 4'}, {'id': 'OG008', 'title': 'Test (Day 5)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) Day 5'}, {'id': 'OG009', 'title': 'Control (Day 5)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 5'}, {'id': 'OG010', 'title': 'Test (Day 6)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) Day 6'}, {'id': 'OG011', 'title': 'Control (Day 6)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 6'}, {'id': 'OG012', 'title': 'Test (Day 7)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) Day 7'}, {'id': 'OG013', 'title': 'Control (Day 7)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 7'}, {'id': 'OG014', 'title': 'Test (Day 8)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) Day 8'}, {'id': 'OG015', 'title': 'Control (Day 8)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) Day 8'}], 'classes': [{'title': 'Increase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '26', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '23', 'groupId': 'OG009'}, {'value': '8', 'groupId': 'OG010'}, {'value': '25', 'groupId': 'OG011'}, {'value': '10', 'groupId': 'OG012'}, {'value': '19', 'groupId': 'OG013'}, {'value': '11', 'groupId': 'OG014'}, {'value': '29', 'groupId': 'OG015'}]}], 'categories': [{'measurements': [{'value': '16.5', 'spread': '3.67', 'groupId': 'OG000'}, {'value': '19.1', 'spread': '8.04', 'groupId': 'OG001'}, {'value': '15.4', 'spread': '4.42', 'groupId': 'OG002'}, {'value': '17.4', 'spread': '8.39', 'groupId': 'OG003'}, {'value': '17.0', 'spread': '5.13', 'groupId': 'OG004'}, {'value': '20.00', 'spread': '8.66', 'groupId': 'OG005'}, {'value': '17.0', 'spread': '5.34', 'groupId': 'OG006'}, {'value': '20.3', 'spread': '8.49', 'groupId': 'OG007'}, {'value': '15.8', 'spread': '5.31', 'groupId': 'OG008'}, {'value': '19.4', 'spread': '9.63', 'groupId': 'OG009'}, {'value': '15.8', 'spread': '7.91', 'groupId': 'OG010'}, {'value': '20.7', 'spread': '9.82', 'groupId': 'OG011'}, {'value': '15.4', 'spread': '9.06', 'groupId': 'OG012'}, {'value': '18.4', 'spread': '8.75', 'groupId': 'OG013'}, {'value': '17.5', 'spread': '7.67', 'groupId': 'OG014'}, {'value': '19.3', 'spread': '8.58', 'groupId': 'OG015'}]}]}, {'title': 'No Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '8', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '8', 'groupId': 'OG012'}, {'value': '2', 'groupId': 'OG013'}, {'value': '8', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}]}], 'categories': [{'measurements': [{'value': '17.4', 'spread': '8.43', 'groupId': 'OG000'}, {'value': '20.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '18.7', 'spread': '8.30', 'groupId': 'OG002'}, {'value': '20.0', 'spread': '0.00', 'groupId': 'OG003'}, {'value': '17.4', 'spread': '8.40', 'groupId': 'OG004'}, {'value': '20.0', 'spread': '0.00', 'groupId': 'OG005'}, {'value': '17.6', 'spread': '8.28', 'groupId': 'OG006'}, {'value': '20.0', 'groupId': 'OG007'}, {'value': '18.4', 'spread': '8.52', 'groupId': 'OG008'}, {'value': '20.0', 'groupId': 'OG009'}, {'value': '17.1', 'spread': '8.54', 'groupId': 'OG010'}, {'value': '20.0', 'spread': '0.00', 'groupId': 'OG011'}, {'value': '17.5', 'spread': '8.33', 'groupId': 'OG012'}, {'value': '20.0', 'spread': '0.00', 'groupId': 'OG013'}, {'value': '17.3', 'spread': '8.48', 'groupId': 'OG014'}, {'value': '20.0', 'spread': '0.00', 'groupId': 'OG015'}]}]}, {'title': '<50% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}, {'value': '44', 'groupId': 'OG006'}, {'value': '17', 'groupId': 'OG007'}, {'value': '43', 'groupId': 'OG008'}, {'value': '19', 'groupId': 'OG009'}, {'value': '43', 'groupId': 'OG010'}, {'value': '22', 'groupId': 'OG011'}, {'value': '47', 'groupId': 'OG012'}, {'value': '21', 'groupId': 'OG013'}, {'value': '56', 'groupId': 'OG014'}, {'value': '24', 'groupId': 'OG015'}]}], 'categories': [{'measurements': [{'value': '19.1', 'spread': '5.92', 'groupId': 'OG000'}, {'value': '17.4', 'spread': '7.12', 'groupId': 'OG001'}, {'value': '17.9', 'spread': '5.50', 'groupId': 'OG002'}, {'value': '19.1', 'spread': '6.48', 'groupId': 'OG003'}, {'value': '17.3', 'spread': '5.06', 'groupId': 'OG004'}, {'value': '20.6', 'spread': '6.45', 'groupId': 'OG005'}, {'value': '18.8', 'spread': '5.42', 'groupId': 'OG006'}, {'value': '21.2', 'spread': '7.06', 'groupId': 'OG007'}, {'value': '17.8', 'spread': '5.64', 'groupId': 'OG008'}, {'value': '20.8', 'spread': '8.30', 'groupId': 'OG009'}, {'value': '17.9', 'spread': '5.77', 'groupId': 'OG010'}, {'value': '19.1', 'spread': '5.77', 'groupId': 'OG011'}, {'value': '18.9', 'spread': '5.39', 'groupId': 'OG012'}, {'value': '18.8', 'spread': '6.74', 'groupId': 'OG013'}, {'value': '18.6', 'spread': '5.21', 'groupId': 'OG014'}, {'value': '19.0', 'spread': '6.87', 'groupId': 'OG015'}]}]}, {'title': '50% to < 100% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '7', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '8', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}], 'categories': [{'measurements': [{'value': '18.4', 'spread': '8.22', 'groupId': 'OG000'}, {'value': '16.2', 'spread': '5.85', 'groupId': 'OG002'}, {'value': '19.1', 'spread': '6.28', 'groupId': 'OG004'}, {'value': '17.4', 'spread': '5.66', 'groupId': 'OG006'}, {'value': '18.6', 'spread': '5.62', 'groupId': 'OG008'}, {'value': '18.3', 'spread': '8.88', 'groupId': 'OG010'}, {'value': '17.4', 'spread': '10.44', 'groupId': 'OG012'}, {'value': '19.0', 'spread': '5.86', 'groupId': 'OG014'}]}]}, {'title': '100% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '2', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}], 'categories': [{'measurements': [{'value': '8.5', 'spread': '4.95', 'groupId': 'OG000'}, {'value': '11.5', 'spread': '4.95', 'groupId': 'OG002'}, {'value': '8.5', 'spread': '2.12', 'groupId': 'OG004'}, {'value': '10.0', 'groupId': 'OG006'}, {'value': '15.0', 'spread': '0.00', 'groupId': 'OG010'}, {'value': '11.5', 'spread': '3.54', 'groupId': 'OG012'}, {'value': '11.0', 'spread': '5.66', 'groupId': 'OG014'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '2', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}], 'categories': [{'measurements': [{'value': '15.0', 'spread': '7.07', 'groupId': 'OG000'}, {'value': '15.0', 'spread': '7.07', 'groupId': 'OG002'}, {'value': '15.5', 'spread': '6.36', 'groupId': 'OG004'}, {'value': '16.0', 'spread': '5.66', 'groupId': 'OG006'}, {'value': '17.0', 'spread': '7.07', 'groupId': 'OG008'}, {'value': '17.0', 'spread': '7.07', 'groupId': 'OG010'}, {'value': '21.0', 'spread': '12.73', 'groupId': 'OG012'}, {'value': '17.5', 'spread': '10.61', 'groupId': 'OG014'}]}]}, {'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '69', 'groupId': 'OG004'}, {'value': '47', 'groupId': 'OG005'}, {'value': '72', 'groupId': 'OG006'}, {'value': '44', 'groupId': 'OG007'}, {'value': '68', 'groupId': 'OG008'}, {'value': '43', 'groupId': 'OG009'}, {'value': '67', 'groupId': 'OG010'}, {'value': '49', 'groupId': 'OG011'}, {'value': '76', 'groupId': 'OG012'}, {'value': '42', 'groupId': 'OG013'}, {'value': '87', 'groupId': 'OG014'}, {'value': '55', 'groupId': 'OG015'}]}], 'categories': [{'measurements': [{'value': '18.2', 'spread': '6.26', 'groupId': 'OG000'}, {'value': '18.4', 'spread': '7.49', 'groupId': 'OG001'}, {'value': '17.3', 'spread': '5.72', 'groupId': 'OG002'}, {'value': '18.2', 'spread': '7.41', 'groupId': 'OG003'}, {'value': '17.2', 'spread': '5.68', 'groupId': 'OG004'}, {'value': '20.2', 'spread': '7.46', 'groupId': 'OG005'}, {'value': '18.1', 'spread': '5.74', 'groupId': 'OG006'}, {'value': '20.7', 'spread': '7.79', 'groupId': 'OG007'}, {'value': '17.6', 'spread': '5.83', 'groupId': 'OG008'}, {'value': '20.0', 'spread': '8.87', 'groupId': 'OG009'}, {'value': '17.4', 'spread': '6.37', 'groupId': 'OG010'}, {'value': '20.0', 'spread': '7.96', 'groupId': 'OG011'}, {'value': '18.0', 'spread': '6.93', 'groupId': 'OG012'}, {'value': '18.7', 'spread': '7.48', 'groupId': 'OG013'}, {'value': '18.2', 'spread': '6.01', 'groupId': 'OG014'}, {'value': '19.2', 'spread': '7.63', 'groupId': 'OG015'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Daily during Baseline Period (Day 1 to Day 8)', 'description': "Summary Statistics of Cigarettes Smoked per Day collected by IVRS Data method on Days 1 to 8 for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \\>50% Reduction', '50 to \\<100% Reduction', '100% Reduction' and 'Missing') are presented.", 'unitOfMeasure': 'cigarettes per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '87', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (Visit 3)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) Visit 3'}, {'id': 'OG001', 'title': 'Control (Visit 3)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 3'}, {'id': 'OG002', 'title': 'Test (End of Study)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) End of Study'}, {'id': 'OG003', 'title': 'Control (End of Study)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study'}, {'id': 'OG004', 'title': 'Test (Change at End of Study/Early Term)', 'description': 'Median change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) from Baseline to End of Study'}, {'id': 'OG005', 'title': 'Control (Change at End of Study/Early Term)', 'description': 'Median change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) from Baseline to End of Study'}], 'classes': [{'categories': [{'measurements': [{'value': '472.893', 'groupId': 'OG000', 'lowerLimit': '42.92', 'upperLimit': '2072.61'}, {'value': '395.108', 'groupId': 'OG001', 'lowerLimit': '41.9', 'upperLimit': '1524.88'}, {'value': '444.709', 'groupId': 'OG002', 'lowerLimit': '16.53', 'upperLimit': '2851.85'}, {'value': '476.795', 'groupId': 'OG003', 'lowerLimit': '59.67', 'upperLimit': '1558.82'}, {'value': '5.448', 'groupId': 'OG004', 'lowerLimit': '-564.08', 'upperLimit': '1872.75'}, {'value': '70.129', 'groupId': 'OG005', 'lowerLimit': '-408.32', 'upperLimit': '683.71'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 8 (Visit 3) and End of Study (Day 36±1)', 'description': 'Median change from baseline to End of Study for urinary total NNAL in Test and Control groups are presented. Baseline = Day 8 (Visit 3) values.', 'unitOfMeasure': 'ng/g', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Population'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '84', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (Visit 3)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) Visit 3'}, {'id': 'OG001', 'title': 'Control (Visit 3)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 3'}, {'id': 'OG002', 'title': 'Test (End of Study)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) End of Study'}, {'id': 'OG003', 'title': 'Control (End of Study)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study'}, {'id': 'OG004', 'title': 'Test (Change at End of Study/Early Term)', 'description': 'Median change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) from Baseline to End of Study'}, {'id': 'OG005', 'title': 'Control (Change at End of Study/Early Term)', 'description': 'Median change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) from Baseline to End of Study'}], 'classes': [{'title': 'Increase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '548.817', 'groupId': 'OG000', 'lowerLimit': '103.304', 'upperLimit': '1289.911'}, {'value': '415.790', 'groupId': 'OG001', 'lowerLimit': '75.406', 'upperLimit': '1238.478'}, {'value': '719.799', 'groupId': 'OG002', 'lowerLimit': '252.923', 'upperLimit': '1424.581'}, {'value': '489.729', 'groupId': 'OG003', 'lowerLimit': '59.671', 'upperLimit': '1188.119'}, {'value': '168.889', 'groupId': 'OG004', 'lowerLimit': '-36.828', 'upperLimit': '376.475'}, {'value': '67.998', 'groupId': 'OG005', 'lowerLimit': '-325.835', 'upperLimit': '638.215'}]}]}, {'title': 'No Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '499.544', 'groupId': 'OG000', 'lowerLimit': '132.328', 'upperLimit': '843.698'}, {'value': '789.559', 'groupId': 'OG001', 'lowerLimit': '54.238', 'upperLimit': '1524.880'}, {'value': '376.087', 'groupId': 'OG002', 'lowerLimit': '175.045', 'upperLimit': '590.850'}, {'value': '592.508', 'groupId': 'OG003', 'lowerLimit': '68.451', 'upperLimit': '1116.564'}, {'value': '30.576', 'groupId': 'OG004', 'lowerLimit': '-467.611', 'upperLimit': '54.268'}, {'value': '-197.051', 'groupId': 'OG005', 'lowerLimit': '-408.315', 'upperLimit': '14.213'}]}]}, {'title': '<50% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '516.752', 'groupId': 'OG000', 'lowerLimit': '42.916', 'upperLimit': '2072.612'}, {'value': '356.857', 'groupId': 'OG001', 'lowerLimit': '41.901', 'upperLimit': '1431.914'}, {'value': '444.709', 'groupId': 'OG002', 'lowerLimit': '18.574', 'upperLimit': '2050.275'}, {'value': '467.615', 'groupId': 'OG003', 'lowerLimit': '84.686', 'upperLimit': '1558.824'}, {'value': '1.776', 'groupId': 'OG004', 'lowerLimit': '-564.082', 'upperLimit': '1208.177'}, {'value': '73.507', 'groupId': 'OG005', 'lowerLimit': '-111.025', 'upperLimit': '683.712'}]}]}, {'title': '50% to < 100% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '375.183', 'groupId': 'OG000', 'lowerLimit': '57.698', 'upperLimit': '979.102'}, {'value': '263.677', 'groupId': 'OG002', 'lowerLimit': '62.899', 'upperLimit': '2851.852'}, {'value': '-48.425', 'groupId': 'OG004', 'lowerLimit': '-365.303', 'upperLimit': '1872.750'}]}]}, {'title': '100% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '158.649', 'groupId': 'OG000', 'lowerLimit': '157.063', 'upperLimit': '160.236'}, {'value': '28.686', 'groupId': 'OG002', 'lowerLimit': '16.528', 'upperLimit': '40.844'}, {'value': '-129.963', 'groupId': 'OG004', 'lowerLimit': '-140.535', 'upperLimit': '-119.392'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '303.452', 'groupId': 'OG000', 'lowerLimit': '124.886', 'upperLimit': '482.019'}, {'value': '268.140', 'groupId': 'OG002', 'lowerLimit': '146.165', 'upperLimit': '390.115'}, {'value': '-35.312', 'groupId': 'OG004', 'lowerLimit': '-91.904', 'upperLimit': '21.279'}]}]}, {'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '84', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '472.893', 'groupId': 'OG000', 'lowerLimit': '42.916', 'upperLimit': '2072.612'}, {'value': '395.108', 'groupId': 'OG001', 'lowerLimit': '41.901', 'upperLimit': '1524.880'}, {'value': '444.709', 'groupId': 'OG002', 'lowerLimit': '16.528', 'upperLimit': '2851.852'}, {'value': '476.795', 'groupId': 'OG003', 'lowerLimit': '59.671', 'upperLimit': '1558.824'}, {'value': '5.448', 'groupId': 'OG004', 'lowerLimit': '-564.082', 'upperLimit': '1872.750'}, {'value': '70.129', 'groupId': 'OG005', 'lowerLimit': '-408.315', 'upperLimit': '683.712'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)', 'description': "Median Change from baseline to End of Study for urinary total NNAL in Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \\>50% Reduction', '50 to \\<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Day 8 (Visit 3) values", 'unitOfMeasure': 'ng/g', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '84', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (Visit 3)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) Visit 3'}, {'id': 'OG001', 'title': 'Control (Visit 3)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 3'}, {'id': 'OG002', 'title': 'Test (End of Study)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) End of Study'}, {'id': 'OG003', 'title': 'Control (End of Study)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study'}, {'id': 'OG004', 'title': 'Test (Change at End of Study/Early Term)', 'description': 'Mean change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) from Baseline to End of Study'}, {'id': 'OG005', 'title': 'Control (Change at End of Study/Early Term)', 'description': 'Mean change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) from Baseline to End of Study'}], 'classes': [{'title': 'Increase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '551.02', 'spread': '318.270', 'groupId': 'OG000'}, {'value': '440.36', 'spread': '261.806', 'groupId': 'OG001'}, {'value': '721.93', 'spread': '327.377', 'groupId': 'OG002'}, {'value': '538.09', 'spread': '287.478', 'groupId': 'OG003'}, {'value': '158.11', 'spread': '140.443', 'groupId': 'OG004'}, {'value': '92.60', 'spread': '227.975', 'groupId': 'OG005'}]}]}, {'title': 'No Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '456.39', 'spread': '275.603', 'groupId': 'OG000'}, {'value': '789.56', 'spread': '1039.900', 'groupId': 'OG001'}, {'value': '389.46', 'spread': '170.153', 'groupId': 'OG002'}, {'value': '592.51', 'spread': '741.128', 'groupId': 'OG003'}, {'value': '-66.92', 'spread': '185.884', 'groupId': 'OG004'}, {'value': '-197.05', 'spread': '298.772', 'groupId': 'OG005'}]}]}, {'title': '<50% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '535.46', 'spread': '393.698', 'groupId': 'OG000'}, {'value': '487.20', 'spread': '378.047', 'groupId': 'OG001'}, {'value': '614.61', 'spread': '517.499', 'groupId': 'OG002'}, {'value': '590.28', 'spread': '451.453', 'groupId': 'OG003'}, {'value': '88.22', 'spread': '320.921', 'groupId': 'OG004'}, {'value': '103.08', 'spread': '170.772', 'groupId': 'OG005'}]}]}, {'title': '50% to < 100% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '443.02', 'spread': '343.687', 'groupId': 'OG000'}, {'value': '592.73', 'spread': '932.562', 'groupId': 'OG002'}, {'value': '149.71', 'spread': '713.457', 'groupId': 'OG004'}]}]}, {'title': '100% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '158.65', 'spread': '2.244', 'groupId': 'OG000'}, {'value': '28.69', 'spread': '17.194', 'groupId': 'OG002'}, {'value': '-129.96', 'spread': '14.950', 'groupId': 'OG004'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '303.45', 'spread': '252.531', 'groupId': 'OG000'}, {'value': '268.14', 'spread': '172.499', 'groupId': 'OG002'}, {'value': '-35.31', 'spread': '80.032', 'groupId': 'OG004'}]}]}, {'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '84', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '507.43', 'spread': '365.172', 'groupId': 'OG000'}, {'value': '473.50', 'spread': '347.581', 'groupId': 'OG001'}, {'value': '586.29', 'spread': '525.084', 'groupId': 'OG002'}, {'value': '563.30', 'spread': '376.309', 'groupId': 'OG003'}, {'value': '81.33', 'spread': '345.110', 'groupId': 'OG004'}, {'value': '86.53', 'spread': '209.749', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)', 'description': "Change from Baseline to End of Study summary statistics of urinary total NNAL (ng/g Creatinine) by Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \\>50% Reduction', '50 to \\<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values.", 'unitOfMeasure': 'ng/g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (%) by Study Group and Cigarette Consumption Categories Over Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '84', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (Visit 3)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) Visit 3'}, {'id': 'OG001', 'title': 'Control (Visit 3)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 3'}, {'id': 'OG002', 'title': 'Test (End of Study)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) End of Study'}, {'id': 'OG003', 'title': 'Control (End of Study)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study'}, {'id': 'OG004', 'title': 'Test (Change at End of Study/Early Term)', 'description': 'Mean change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) from Baseline to End of Study'}, {'id': 'OG005', 'title': 'Control (Change at End of Study/Early Term)', 'description': 'Mean change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) from Baseline to End of Study'}], 'classes': [{'title': 'Increase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '551.02', 'spread': '318.270', 'groupId': 'OG000'}, {'value': '440.36', 'spread': '261.806', 'groupId': 'OG001'}, {'value': '721.93', 'spread': '327.377', 'groupId': 'OG002'}, {'value': '538.09', 'spread': '287.478', 'groupId': 'OG003'}, {'value': '43.2', 'spread': '49.11', 'groupId': 'OG004'}, {'value': '31.7', 'spread': '66.12', 'groupId': 'OG005'}]}]}, {'title': 'No Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '456.39', 'spread': '275.603', 'groupId': 'OG000'}, {'value': '789.56', 'spread': '1039.900', 'groupId': 'OG001'}, {'value': '389.46', 'spread': '170.153', 'groupId': 'OG002'}, {'value': '592.51', 'spread': '741.128', 'groupId': 'OG003'}, {'value': '-0.3', 'spread': '29.55', 'groupId': 'OG004'}, {'value': '-0.3', 'spread': '37.46', 'groupId': 'OG005'}]}]}, {'title': '<50% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '535.46', 'spread': '393.698', 'groupId': 'OG000'}, {'value': '487.20', 'spread': '378.047', 'groupId': 'OG001'}, {'value': '614.61', 'spread': '517.499', 'groupId': 'OG002'}, {'value': '590.28', 'spread': '451.453', 'groupId': 'OG003'}, {'value': '17.6', 'spread': '63.88', 'groupId': 'OG004'}, {'value': '26.9', 'spread': '48.80', 'groupId': 'OG005'}]}]}, {'title': '50% to < 100% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '443.02', 'spread': '343.687', 'groupId': 'OG000'}, {'value': '592.73', 'spread': '932.562', 'groupId': 'OG002'}, {'value': '7.3', 'spread': '80.69', 'groupId': 'OG004'}]}]}, {'title': '100% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '158.65', 'spread': '2.244', 'groupId': 'OG000'}, {'value': '28.69', 'spread': '17.194', 'groupId': 'OG002'}, {'value': '-82.0', 'spread': '10.58', 'groupId': 'OG004'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '303.45', 'spread': '252.531', 'groupId': 'OG000'}, {'value': '268.14', 'spread': '172.499', 'groupId': 'OG002'}, {'value': '-1.0', 'spread': '25.53', 'groupId': 'OG004'}]}]}, {'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '84', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '507.43', 'spread': '365.172', 'groupId': 'OG000'}, {'value': '473.50', 'spread': '347.581', 'groupId': 'OG001'}, {'value': '586.29', 'spread': '525.084', 'groupId': 'OG002'}, {'value': '563.30', 'spread': '376.309', 'groupId': 'OG003'}, {'value': '15.4', 'spread': '62.42', 'groupId': 'OG004'}, {'value': '28.4', 'spread': '57.66', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)', 'description': "Percent change from Baseline to End of study summary statistics of urinary total NNAL (%) for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \\>50% Reduction', '50 to \\<100% Reduction', '100% Reduction' and 'Missing') are presented.\n\nBaseline = Visit 3 (Day 8) values.", 'unitOfMeasure': 'percent change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (mg/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '74', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (Visit 3)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) Visit 3'}, {'id': 'OG001', 'title': 'Control (Visit 3)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 3'}, {'id': 'OG002', 'title': 'Test (End of Study)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) End of Study'}, {'id': 'OG003', 'title': 'Control (End of Study)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study'}, {'id': 'OG004', 'title': 'Test (Change at End of Study/Early Term)', 'description': 'Mean change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) from Baseline to End of Study'}, {'id': 'OG005', 'title': 'Control (Change at End of Study/Early Term)', 'description': 'Mean change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) from Baseline to End of Study'}], 'classes': [{'title': 'Increase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '18.24', 'spread': '14.941', 'groupId': 'OG000'}, {'value': '13.70', 'spread': '7.870', 'groupId': 'OG001'}, {'value': '24.84', 'spread': '14.892', 'groupId': 'OG002'}, {'value': '16.55', 'spread': '6.791', 'groupId': 'OG003'}, {'value': '6.77', 'spread': '7.432', 'groupId': 'OG004'}, {'value': '3.73', 'spread': '5.932', 'groupId': 'OG005'}]}]}, {'title': 'No Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '8.75', 'spread': '4.809', 'groupId': 'OG000'}, {'value': '8.14', 'groupId': 'OG001'}, {'value': '10.23', 'spread': '3.053', 'groupId': 'OG002'}, {'value': '13.62', 'spread': '1.600', 'groupId': 'OG003'}, {'value': '1.48', 'spread': '3.418', 'groupId': 'OG004'}, {'value': '6.61', 'groupId': 'OG005'}]}]}, {'title': '<50% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '15.00', 'spread': '9.726', 'groupId': 'OG000'}, {'value': '14.77', 'spread': '10.432', 'groupId': 'OG001'}, {'value': '16.07', 'spread': '11.551', 'groupId': 'OG002'}, {'value': '18.07', 'spread': '14.909', 'groupId': 'OG003'}, {'value': '1.80', 'spread': '9.214', 'groupId': 'OG004'}, {'value': '3.29', 'spread': '8.011', 'groupId': 'OG005'}]}]}, {'title': '50% to < 100% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '11.51', 'spread': '6.995', 'groupId': 'OG000'}, {'value': '16.62', 'spread': '22.808', 'groupId': 'OG002'}, {'value': '4.89', 'spread': '20.082', 'groupId': 'OG004'}]}]}, {'title': '100% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '8.19', 'spread': '1.870', 'groupId': 'OG000'}, {'value': '7.41', 'groupId': 'OG002'}, {'value': '-2.11', 'groupId': 'OG004'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '9.09', 'spread': '1.956', 'groupId': 'OG000'}, {'value': '8.81', 'spread': '0.629', 'groupId': 'OG002'}, {'value': '-0.28', 'spread': '2.585', 'groupId': 'OG004'}]}]}, {'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '74', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '14.32', 'spread': '9.996', 'groupId': 'OG000'}, {'value': '14.06', 'spread': '8.973', 'groupId': 'OG001'}, {'value': '16.60', 'spread': '13.108', 'groupId': 'OG002'}, {'value': '17.13', 'spread': '11.092', 'groupId': 'OG003'}, {'value': '2.59', 'spread': '9.748', 'groupId': 'OG004'}, {'value': '3.59', 'spread': '6.886', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)', 'description': "Change from Baseline to End of Study summary statistics of urinary nicotine equivalents (mg/g creatinine) by Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \\>50% Reduction', '50 to \\<100% Reduction', '100% Reduction' and 'Missing') are presented.\n\nNicotine equivalents include nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide).\n\nBaseline = Visit 3 (Day 8) values.", 'unitOfMeasure': 'mg/g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (%) by Study Group and Cigarette Consumption Categories Over Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '74', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (Visit 3)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) Visit 3'}, {'id': 'OG001', 'title': 'Control (Visit 3)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 3'}, {'id': 'OG002', 'title': 'Test (End of Study)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) End of Study'}, {'id': 'OG003', 'title': 'Control (End of Study)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study'}, {'id': 'OG004', 'title': 'Test (Change at End of Study/Early Term)', 'description': 'Mean change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) from Baseline to End of Study'}, {'id': 'OG005', 'title': 'Control (Change at End of Study/Early Term)', 'description': 'Mean change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) from Baseline to End of Study'}], 'classes': [{'title': 'Increase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '18.24', 'spread': '14.941', 'groupId': 'OG000'}, {'value': '13.70', 'spread': '7.870', 'groupId': 'OG001'}, {'value': '24.84', 'spread': '14.892', 'groupId': 'OG002'}, {'value': '16.55', 'spread': '6.791', 'groupId': 'OG003'}, {'value': '62.5', 'spread': '69.50', 'groupId': 'OG004'}, {'value': '41.1', 'spread': '72.40', 'groupId': 'OG005'}]}]}, {'title': 'No Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '8.75', 'spread': '4.809', 'groupId': 'OG000'}, {'value': '8.14', 'groupId': 'OG001'}, {'value': '10.23', 'spread': '3.053', 'groupId': 'OG002'}, {'value': '13.62', 'spread': '1.600', 'groupId': 'OG003'}, {'value': '40.0', 'spread': '55.51', 'groupId': 'OG004'}, {'value': '81.1', 'groupId': 'OG005'}]}]}, {'title': '<50% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '15.00', 'spread': '9.726', 'groupId': 'OG000'}, {'value': '14.77', 'spread': '10.432', 'groupId': 'OG001'}, {'value': '16.07', 'spread': '11.551', 'groupId': 'OG002'}, {'value': '18.07', 'spread': '14.909', 'groupId': 'OG003'}, {'value': '19.0', 'spread': '61.98', 'groupId': 'OG004'}, {'value': '27.6', 'spread': '46.51', 'groupId': 'OG005'}]}]}, {'title': '50% to < 100% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '11.51', 'spread': '6.995', 'groupId': 'OG000'}, {'value': '16.62', 'spread': '22.808', 'groupId': 'OG002'}, {'value': '15.1', 'spread': '93.59', 'groupId': 'OG004'}]}]}, {'title': '100% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '8.19', 'spread': '1.870', 'groupId': 'OG000'}, {'value': '7.41', 'groupId': 'OG002'}, {'value': '-22.1', 'groupId': 'OG004'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '9.09', 'spread': '1.956', 'groupId': 'OG000'}, {'value': '8.81', 'spread': '0.629', 'groupId': 'OG002'}, {'value': '-0.1', 'spread': '28.42', 'groupId': 'OG004'}]}]}, {'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '74', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '14.32', 'spread': '9.996', 'groupId': 'OG000'}, {'value': '14.06', 'spread': '8.973', 'groupId': 'OG001'}, {'value': '16.60', 'spread': '13.108', 'groupId': 'OG002'}, {'value': '17.13', 'spread': '11.092', 'groupId': 'OG003'}, {'value': '25.2', 'spread': '65.08', 'groupId': 'OG004'}, {'value': '35.5', 'spread': '60.54', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)', 'description': "Percent change from Baseline to End of study summary statistics of urinary nicotine equivalents (%) for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \\>50% Reduction', '50 to \\<100% Reduction', '100% Reduction' and 'Missing') are presented.\n\nNicotine equivalents include nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide).\n\nBaseline = Visit 3 (Day 8) values.", 'unitOfMeasure': 'percent change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to End of Study Summary Statistics of S-PMA (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '81', 'groupId': 'OG004'}, {'value': '51', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (Visit 3)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) Visit 3'}, {'id': 'OG001', 'title': 'Control (Visit 3)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 3'}, {'id': 'OG002', 'title': 'Test (End of Study)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) End of Study'}, {'id': 'OG003', 'title': 'Control (End of Study)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study'}, {'id': 'OG004', 'title': 'Test (Change at End of Study/Early Term)', 'description': 'Mean change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) from Baseline to End of Study'}, {'id': 'OG005', 'title': 'Control (Change at End of Study/Early Term)', 'description': 'Mean change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) from Baseline to End of Study'}], 'classes': [{'title': 'Increase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '5731.61', 'spread': '5064.881', 'groupId': 'OG000'}, {'value': '4934.00', 'spread': '4812.350', 'groupId': 'OG001'}, {'value': '8389.80', 'spread': '6625.523', 'groupId': 'OG002'}, {'value': '6358.61', 'spread': '5253.083', 'groupId': 'OG003'}, {'value': '2410.02', 'spread': '2986.346', 'groupId': 'OG004'}, {'value': '1341.70', 'spread': '2495.655', 'groupId': 'OG005'}]}]}, {'title': 'No Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '4216.93', 'spread': '2660.723', 'groupId': 'OG000'}, {'value': '6930.38', 'spread': '5483.666', 'groupId': 'OG001'}, {'value': '4352.99', 'spread': '3873.342', 'groupId': 'OG002'}, {'value': '8688.22', 'spread': '3272.243', 'groupId': 'OG003'}, {'value': '136.06', 'spread': '3959.381', 'groupId': 'OG004'}, {'value': '1757.84', 'spread': '2211.423', 'groupId': 'OG005'}]}]}, {'title': '<50% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '6495.06', 'spread': '5936.803', 'groupId': 'OG000'}, {'value': '5356.63', 'spread': '5359.524', 'groupId': 'OG001'}, {'value': '7335.57', 'spread': '7068.643', 'groupId': 'OG002'}, {'value': '6481.35', 'spread': '6132.009', 'groupId': 'OG003'}, {'value': '875.52', 'spread': '4755.856', 'groupId': 'OG004'}, {'value': '903.68', 'spread': '3218.825', 'groupId': 'OG005'}]}]}, {'title': '50% to < 100% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '5352.66', 'spread': '8413.472', 'groupId': 'OG000'}, {'value': '9795.94', 'spread': '12602.08', 'groupId': 'OG002'}, {'value': '1941.73', 'spread': '11042.40', 'groupId': 'OG004'}]}]}, {'title': '100% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '5510.19', 'spread': '123.439', 'groupId': 'OG000'}, {'value': '440.59', 'spread': '225.383', 'groupId': 'OG002'}, {'value': '-5069.60', 'spread': '101.944', 'groupId': 'OG004'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2693.13', 'spread': '1334.197', 'groupId': 'OG000'}, {'value': '2896.76', 'spread': '1518.588', 'groupId': 'OG002'}, {'value': '203.64', 'spread': '184.391', 'groupId': 'OG004'}]}]}, {'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '81', 'groupId': 'OG004'}, {'value': '51', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '5991.56', 'spread': '5741.490', 'groupId': 'OG000'}, {'value': '5195.78', 'spread': '4999.201', 'groupId': 'OG001'}, {'value': '7098.86', 'spread': '7113.465', 'groupId': 'OG002'}, {'value': '6502.50', 'spread': '5540.461', 'groupId': 'OG003'}, {'value': '903.49', 'spread': '4985.072', 'groupId': 'OG004'}, {'value': '1160.48', 'spread': '2798.644', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)', 'description': "Change from Baseline to End of Study summary statistics of urinary S-phenyl mercapturic acid \\[S-PMA\\] (ng/g creatinine) by Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \\>50% Reduction', '50 to \\<100% Reduction', '100% Reduction' and 'Missing') are presented.\n\nBaseline = Visit 3 (Day 8) values.", 'unitOfMeasure': 'ng/g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to End of Study Summary Statistics of S-PMA (%) by Study Group and Cigarette Consumption Categories Over Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '81', 'groupId': 'OG004'}, {'value': '51', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (Visit 3)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) Visit 3'}, {'id': 'OG001', 'title': 'Control (Visit 3)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 3'}, {'id': 'OG002', 'title': 'Test (End of Study)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) End of Study'}, {'id': 'OG003', 'title': 'Control (End of Study)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study'}, {'id': 'OG004', 'title': 'Test (Change at End of Study/Early Term)', 'description': 'Mean change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) from Baseline to End of Study'}, {'id': 'OG005', 'title': 'Control (Change at End of Study/Early Term)', 'description': 'Mean change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) from Baseline to End of Study'}], 'classes': [{'title': 'Increase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '5731.61', 'spread': '5064.881', 'groupId': 'OG000'}, {'value': '4934.00', 'spread': '4812.350', 'groupId': 'OG001'}, {'value': '8389.80', 'spread': '6625.523', 'groupId': 'OG002'}, {'value': '6358.61', 'spread': '5253.083', 'groupId': 'OG003'}, {'value': '50.0', 'spread': '58.51', 'groupId': 'OG004'}, {'value': '46.5', 'spread': '76.26', 'groupId': 'OG005'}]}]}, {'title': 'No Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '4216.93', 'spread': '2660.723', 'groupId': 'OG000'}, {'value': '6930.38', 'spread': '5483.666', 'groupId': 'OG001'}, {'value': '4352.99', 'spread': '3873.342', 'groupId': 'OG002'}, {'value': '8688.22', 'spread': '3272.243', 'groupId': 'OG003'}, {'value': '16.1', 'spread': '61.36', 'groupId': 'OG004'}, {'value': '55.3', 'spread': '75.66', 'groupId': 'OG005'}]}]}, {'title': '<50% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '6495.06', 'spread': '5936.803', 'groupId': 'OG000'}, {'value': '5356.63', 'spread': '5359.524', 'groupId': 'OG001'}, {'value': '7335.57', 'spread': '7068.643', 'groupId': 'OG002'}, {'value': '6481.35', 'spread': '6132.009', 'groupId': 'OG003'}, {'value': '19.9', 'spread': '76.46', 'groupId': 'OG004'}, {'value': '29.4', 'spread': '66.18', 'groupId': 'OG005'}]}]}, {'title': '50% to < 100% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '5352.66', 'spread': '8413.472', 'groupId': 'OG000'}, {'value': '9795.94', 'spread': '12602.08', 'groupId': 'OG002'}, {'value': '30.3', 'spread': '123.78', 'groupId': 'OG004'}]}]}, {'title': '100% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '5510.19', 'spread': '123.439', 'groupId': 'OG000'}, {'value': '440.59', 'spread': '225.383', 'groupId': 'OG002'}, {'value': '-92.0', 'spread': '3.91', 'groupId': 'OG004'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2693.13', 'spread': '1334.197', 'groupId': 'OG000'}, {'value': '2896.76', 'spread': '1518.588', 'groupId': 'OG002'}, {'value': '6.7', 'spread': '3.53', 'groupId': 'OG004'}]}]}, {'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '81', 'groupId': 'OG004'}, {'value': '51', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '5991.56', 'spread': '5741.490', 'groupId': 'OG000'}, {'value': '5195.78', 'spread': '4999.201', 'groupId': 'OG001'}, {'value': '7098.86', 'spread': '7113.465', 'groupId': 'OG002'}, {'value': '6502.50', 'spread': '5540.461', 'groupId': 'OG003'}, {'value': '20.9', 'spread': '76.27', 'groupId': 'OG004'}, {'value': '39.1', 'spread': '70.93', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)', 'description': "Percent change from Baseline to End of study summary statistics of urinary S-phenyl mercapturic acid \\[S-PMA\\] (%) for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \\>50% Reduction', '50 to \\<100% Reduction', '100% Reduction' and 'Missing') are presented.\n\nBaseline = Visit 3 (Day 8) values.", 'unitOfMeasure': 'percent change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '87', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (Visit 3)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) Visit 3'}, {'id': 'OG001', 'title': 'Control (Visit 3)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 3'}, {'id': 'OG002', 'title': 'Test (End of Study)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) End of Study'}, {'id': 'OG003', 'title': 'Control (End of Study)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study'}, {'id': 'OG004', 'title': 'Test (Change at End of Study/Early Term)', 'description': 'Mean change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) from Baseline to End of Study'}, {'id': 'OG005', 'title': 'Control (Change at End of Study/Early Term)', 'description': 'Mean change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) from Baseline to End of Study'}], 'classes': [{'title': 'Increase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '29', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '6.62', 'spread': '2.151', 'groupId': 'OG000'}, {'value': '5.31', 'spread': '1.627', 'groupId': 'OG001'}, {'value': '5.97', 'spread': '1.803', 'groupId': 'OG002'}, {'value': '5.39', 'spread': '1.786', 'groupId': 'OG003'}, {'value': '-0.65', 'spread': '1.099', 'groupId': 'OG004'}, {'value': '0.09', 'spread': '1.178', 'groupId': 'OG005'}]}]}, {'title': 'No Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '5.68', 'spread': '2.153', 'groupId': 'OG000'}, {'value': '3.65', 'spread': '2.192', 'groupId': 'OG001'}, {'value': '5.00', 'spread': '1.278', 'groupId': 'OG002'}, {'value': '4.60', 'spread': '1.414', 'groupId': 'OG003'}, {'value': '-0.68', 'spread': '1.342', 'groupId': 'OG004'}, {'value': '0.95', 'spread': '0.778', 'groupId': 'OG005'}]}]}, {'title': '<50% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '5.40', 'spread': '1.918', 'groupId': 'OG000'}, {'value': '4.99', 'spread': '2.184', 'groupId': 'OG001'}, {'value': '5.11', 'spread': '2.066', 'groupId': 'OG002'}, {'value': '4.57', 'spread': '1.847', 'groupId': 'OG003'}, {'value': '-0.29', 'spread': '1.323', 'groupId': 'OG004'}, {'value': '-0.42', 'spread': '0.986', 'groupId': 'OG005'}]}]}, {'title': '50% to < 100% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '5.36', 'spread': '2.159', 'groupId': 'OG000'}, {'value': '3.21', 'spread': '1.870', 'groupId': 'OG002'}, {'value': '-2.15', 'spread': '0.952', 'groupId': 'OG004'}]}]}, {'title': '100% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '4.45', 'spread': '0.354', 'groupId': 'OG000'}, {'value': '1.45', 'spread': '0.212', 'groupId': 'OG002'}, {'value': '-3.00', 'spread': '0.141', 'groupId': 'OG004'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '4.25', 'spread': '2.333', 'groupId': 'OG000'}, {'value': '3.65', 'spread': '0.919', 'groupId': 'OG002'}, {'value': '-0.60', 'spread': '1.414', 'groupId': 'OG004'}]}]}, {'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '87', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '5.53', 'spread': '1.986', 'groupId': 'OG000'}, {'value': '5.11', 'spread': '1.897', 'groupId': 'OG001'}, {'value': '4.91', 'spread': '2.071', 'groupId': 'OG002'}, {'value': '5.00', 'spread': '1.821', 'groupId': 'OG003'}, {'value': '-0.61', 'spread': '1.387', 'groupId': 'OG004'}, {'value': '-0.10', 'spread': '1.118', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)', 'description': "Change from Baseline to End of Study summary statistics of blood carboxyhemoglobin (%) by Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \\>50% Reduction', '50 to \\<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values.", 'unitOfMeasure': 'percent saturation of carboxyhemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '87', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (Visit 3)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) Visit 3'}, {'id': 'OG001', 'title': 'Control (Visit 3)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 3'}, {'id': 'OG002', 'title': 'Test (End of Study)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) End of Study'}, {'id': 'OG003', 'title': 'Control (End of Study)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study'}, {'id': 'OG004', 'title': 'Test (Change at End of Study/Early Term)', 'description': 'Mean change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) from Baseline to End of Study'}, {'id': 'OG005', 'title': 'Control (Change at End of Study/Early Term)', 'description': 'Mean change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) from Baseline to End of Study'}], 'classes': [{'title': 'Increase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '29', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '6.62', 'spread': '2.151', 'groupId': 'OG000'}, {'value': '5.31', 'spread': '1.627', 'groupId': 'OG001'}, {'value': '5.97', 'spread': '1.803', 'groupId': 'OG002'}, {'value': '5.39', 'spread': '1.786', 'groupId': 'OG003'}, {'value': '-7.6', 'spread': '17.41', 'groupId': 'OG004'}, {'value': '3.6', 'spread': '27.54', 'groupId': 'OG005'}]}]}, {'title': 'No Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '5.68', 'spread': '2.153', 'groupId': 'OG000'}, {'value': '3.65', 'spread': '2.192', 'groupId': 'OG001'}, {'value': '5.00', 'spread': '1.278', 'groupId': 'OG002'}, {'value': '4.60', 'spread': '1.414', 'groupId': 'OG003'}, {'value': '-4.0', 'spread': '29.21', 'groupId': 'OG004'}, {'value': '39.6', 'spread': '45.07', 'groupId': 'OG005'}]}]}, {'title': '<50% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '5.40', 'spread': '1.918', 'groupId': 'OG000'}, {'value': '4.99', 'spread': '2.184', 'groupId': 'OG001'}, {'value': '5.11', 'spread': '2.066', 'groupId': 'OG002'}, {'value': '4.57', 'spread': '1.847', 'groupId': 'OG003'}, {'value': '-3.7', 'spread': '25.91', 'groupId': 'OG004'}, {'value': '-6.1', 'spread': '18.12', 'groupId': 'OG005'}]}]}, {'title': '50% to < 100% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '5.36', 'spread': '2.159', 'groupId': 'OG000'}, {'value': '3.21', 'spread': '1.870', 'groupId': 'OG002'}, {'value': '-42.5', 'spread': '18.66', 'groupId': 'OG004'}]}]}, {'title': '100% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '4.45', 'spread': '0.354', 'groupId': 'OG000'}, {'value': '1.45', 'spread': '0.212', 'groupId': 'OG002'}, {'value': '-67.5', 'spread': '2.19', 'groupId': 'OG004'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '4.25', 'spread': '2.333', 'groupId': 'OG000'}, {'value': '3.65', 'spread': '0.919', 'groupId': 'OG002'}, {'value': '-5.9', 'spread': '30.05', 'groupId': 'OG004'}]}]}, {'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '87', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '5.53', 'spread': '1.986', 'groupId': 'OG000'}, {'value': '5.11', 'spread': '1.897', 'groupId': 'OG001'}, {'value': '4.91', 'spread': '2.071', 'groupId': 'OG002'}, {'value': '5.00', 'spread': '1.821', 'groupId': 'OG003'}, {'value': '-9.3', 'spread': '27.89', 'groupId': 'OG004'}, {'value': '0.7', 'spread': '25.53', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)', 'description': "Percent change from Baseline to End of study summary statistics of blood carboxyhemoglobin (%) for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \\>50% Reduction', '50 to \\<100% Reduction', '100% Reduction' and 'Missing') are presented.\n\nBaseline = Visit 3 (Day 8) values.", 'unitOfMeasure': 'percent change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (Ppm) by Study Group and Cigarette Consumption Categories Over Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '87', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (Visit 3)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) Visit 3'}, {'id': 'OG001', 'title': 'Control (Visit 3)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 3'}, {'id': 'OG002', 'title': 'Test (End of Study)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) End of Study'}, {'id': 'OG003', 'title': 'Control (End of Study)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study'}, {'id': 'OG004', 'title': 'Test (Change at End of Study/Early Term)', 'description': 'Mean change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) from Baseline to End of Study'}, {'id': 'OG005', 'title': 'Control (Change at End of Study/Early Term)', 'description': 'Mean change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) from Baseline to End of Study'}], 'classes': [{'title': 'Increase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '29', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '29.64', 'spread': '12.118', 'groupId': 'OG000'}, {'value': '20.59', 'spread': '9.109', 'groupId': 'OG001'}, {'value': '25.91', 'spread': '8.860', 'groupId': 'OG002'}, {'value': '20.21', 'spread': '9.537', 'groupId': 'OG003'}, {'value': '-3.73', 'spread': '10.248', 'groupId': 'OG004'}, {'value': '-0.38', 'spread': '7.894', 'groupId': 'OG005'}]}]}, {'title': 'No Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '22.50', 'spread': '9.562', 'groupId': 'OG000'}, {'value': '11.50', 'spread': '10.607', 'groupId': 'OG001'}, {'value': '21.50', 'spread': '9.957', 'groupId': 'OG002'}, {'value': '18.50', 'spread': '2.121', 'groupId': 'OG003'}, {'value': '-1.00', 'spread': '9.798', 'groupId': 'OG004'}, {'value': '7.00', 'spread': '8.485', 'groupId': 'OG005'}]}]}, {'title': '<50% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '21.32', 'spread': '10.133', 'groupId': 'OG000'}, {'value': '20.96', 'spread': '11.126', 'groupId': 'OG001'}, {'value': '21.13', 'spread': '10.091', 'groupId': 'OG002'}, {'value': '19.08', 'spread': '8.707', 'groupId': 'OG003'}, {'value': '-0.46', 'spread': '8.466', 'groupId': 'OG004'}, {'value': '-1.88', 'spread': '5.102', 'groupId': 'OG005'}]}]}, {'title': '50% to < 100% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '20.63', 'spread': '9.855', 'groupId': 'OG000'}, {'value': '9.88', 'spread': '6.081', 'groupId': 'OG002'}, {'value': '-10.75', 'spread': '8.172', 'groupId': 'OG004'}]}]}, {'title': '100% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '17.00', 'spread': '4.243', 'groupId': 'OG000'}, {'value': '4.00', 'spread': '2.828', 'groupId': 'OG002'}, {'value': '-13.00', 'spread': '1.414', 'groupId': 'OG004'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '18.50', 'spread': '16.263', 'groupId': 'OG000'}, {'value': '13.00', 'spread': '8.485', 'groupId': 'OG002'}, {'value': '-5.50', 'spread': '7.778', 'groupId': 'OG004'}]}]}, {'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '87', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '22.24', 'spread': '10.491', 'groupId': 'OG000'}, {'value': '20.42', 'spread': '10.046', 'groupId': 'OG001'}, {'value': '20.15', 'spread': '10.410', 'groupId': 'OG002'}, {'value': '19.65', 'spread': '8.939', 'groupId': 'OG003'}, {'value': '-2.28', 'spread': '9.175', 'groupId': 'OG004'}, {'value': '-0.76', 'spread': '6.899', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)', 'description': "Change from Baseline to End of Study summary statistics of exhaled carbon monoxide (ppm) by Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \\>50% Reduction', '50 to \\<100% Reduction', '100% Reduction' and 'Missing') are presented.\n\nBaseline = Visit 3 (Day 8) values.", 'unitOfMeasure': 'ppm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (%) by Study Group and Cigarette Consumption Categories Over Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '87', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (Visit 3)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) Visit 3'}, {'id': 'OG001', 'title': 'Control (Visit 3)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) Visit 3'}, {'id': 'OG002', 'title': 'Test (End of Study)', 'description': 'Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) End of Study'}, {'id': 'OG003', 'title': 'Control (End of Study)', 'description': 'Control Group (subjects continued ad libitum use of their own brand of tobacco products) End of Study'}, {'id': 'OG004', 'title': 'Test (Change at End of Study/Early Term)', 'description': 'Mean change in Test Group (subjects continued ad libitum use of their own brand of tobacco products and permitted ad libitum use of the test product \\[VBM-FG2 oral discs\\]) from Baseline to End of Study'}, {'id': 'OG005', 'title': 'Control (Change at End of Study/Early Term)', 'description': 'Mean change in Control Group (subjects continued ad libitum use of their own brand of tobacco products) from Baseline to End of Study'}], 'classes': [{'title': 'Increase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '29', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '29.64', 'spread': '12.118', 'groupId': 'OG000'}, {'value': '20.59', 'spread': '9.109', 'groupId': 'OG001'}, {'value': '25.91', 'spread': '8.860', 'groupId': 'OG002'}, {'value': '20.21', 'spread': '9.537', 'groupId': 'OG003'}, {'value': '-7.0', 'spread': '32.63', 'groupId': 'OG004'}, {'value': '6.8', 'spread': '58.17', 'groupId': 'OG005'}]}]}, {'title': 'No Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '22.50', 'spread': '9.562', 'groupId': 'OG000'}, {'value': '11.50', 'spread': '10.607', 'groupId': 'OG001'}, {'value': '21.50', 'spread': '9.957', 'groupId': 'OG002'}, {'value': '18.50', 'spread': '2.121', 'groupId': 'OG003'}, {'value': '6.6', 'spread': '45.21', 'groupId': 'OG004'}, {'value': '165.1', 'spread': '226.09', 'groupId': 'OG005'}]}]}, {'title': '<50% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '21.32', 'spread': '10.133', 'groupId': 'OG000'}, {'value': '20.96', 'spread': '11.126', 'groupId': 'OG001'}, {'value': '21.13', 'spread': '10.091', 'groupId': 'OG002'}, {'value': '19.08', 'spread': '8.707', 'groupId': 'OG003'}, {'value': '6.0', 'spread': '47.63', 'groupId': 'OG004'}, {'value': '-1.4', 'spread': '40.74', 'groupId': 'OG005'}]}]}, {'title': '50% to < 100% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '20.63', 'spread': '9.855', 'groupId': 'OG000'}, {'value': '9.88', 'spread': '6.081', 'groupId': 'OG002'}, {'value': '-49.2', 'spread': '27.25', 'groupId': 'OG004'}]}]}, {'title': '100% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '17.00', 'spread': '4.243', 'groupId': 'OG000'}, {'value': '4.00', 'spread': '2.828', 'groupId': 'OG002'}, {'value': '-77.9', 'spread': '11.11', 'groupId': 'OG004'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '18.50', 'spread': '16.263', 'groupId': 'OG000'}, {'value': '13.00', 'spread': '8.485', 'groupId': 'OG002'}, {'value': '-18.3', 'spread': '25.93', 'groupId': 'OG004'}]}]}, {'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '87', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '22.24', 'spread': '10.491', 'groupId': 'OG000'}, {'value': '20.42', 'spread': '10.046', 'groupId': 'OG001'}, {'value': '20.15', 'spread': '10.410', 'groupId': 'OG002'}, {'value': '19.65', 'spread': '8.939', 'groupId': 'OG003'}, {'value': '-3.1', 'spread': '47.00', 'groupId': 'OG004'}, {'value': '9.0', 'spread': '66.04', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)', 'description': "Percent change from Baseline to End of study summary statistics of exhaled carbon monoxide for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \\>50% Reduction', '50 to \\<100% Reduction', '100% Reduction' and 'Missing') are presented.\n\nBaseline = Visit 3 (Day 8) values.", 'unitOfMeasure': 'percent change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results.'}, {'type': 'SECONDARY', 'title': 'Characterization of Subgroups Based on Change From Baseline in Total NNAL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (ad Libitum VBM-FG2)', 'description': 'Subjects were allowed to continue smoking their own brand of cigarettes ad libitum and were provided the option to use the test product (VBM-FG2 oral discs) also under ad libitum conditions)'}, {'id': 'OG001', 'title': 'Control (no VBM-FG2)', 'description': 'Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks'}], 'classes': [{'categories': [{'title': 'Increase', 'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'title': 'Reduction', 'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1661', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Probability', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.1661', 'estimateComment': 'Estimated value is the probability of observed distribution assuming the null hypothesis', 'groupDescription': 'Null hypothesis = Test and Control groups will have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Null hypothesis = Test and Control groups will have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study'}, {'pValue': '0.2139', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Probability', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.2139', 'estimateComment': 'Estimated value is the probability of observed distribution assuming the null hypothesis', 'groupDescription': 'Null hypothesis = Test and Control groups will have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Null hypothesis = Test and Control groups will have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)', 'description': 'Statistical analyses on the number of subjects in subgroups based on urinary total NNAL change from baseline to the last visit are presented.\n\nBaseline = Visit 3 values.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Test (ad Libitum VERVE® Discs Blue Mint [VBM-FG2] Use)', 'description': 'Subjects were allowed to continue smoking their own brand of cigarettes ad libitum and were provided the option to use the test product (VBM-FG2 oral discs) also under ad libitum conditions.'}, {'id': 'FG001', 'title': 'Control (no VBM-FG2)', 'description': 'Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Subjects were required to complete an 8 day baseline assessment during which subject cigarette use data was collected using daily interactive voice response system (IVRS) calls and recall of the previous week methods. Three subjects were withdrawn from the study prior to randomization. A total of 154 subjects were randomized in this study; 92 subjects were randomized to the Test Group and 62 subjects were randomized to the Control Group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Test (ad Libitum VBM-FG2)', 'description': 'Subjects were allowed to continue smoking their own brand of cigarettes ad libitum and were provided the option to use the test product (VBM-FG2 oral discs) also under ad libitum conditions'}, {'id': 'BG001', 'title': 'Control (no VBM-FG2)', 'description': 'Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000', 'lowerLimit': '21', 'upperLimit': '65'}, {'value': '42', 'groupId': 'BG001', 'lowerLimit': '21', 'upperLimit': '64'}, {'value': '43', 'groupId': 'BG002', 'lowerLimit': '21', 'upperLimit': '65'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '82.8', 'spread': '20.94', 'groupId': 'BG000'}, {'value': '85.3', 'spread': '23.56', 'groupId': 'BG001'}, {'value': '83.8', 'spread': '21.99', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '170.8', 'spread': '8.32', 'groupId': 'BG000'}, {'value': '171.1', 'spread': '9.40', 'groupId': 'BG001'}, {'value': '170.9', 'spread': '8.75', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '28.3', 'spread': '6.69', 'groupId': 'BG000'}, {'value': '29.0', 'spread': '7.26', 'groupId': 'BG001'}, {'value': '28.6', 'spread': '6.91', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Quit Attempts', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Quit Attempts and Quitting Intentions Questionnaire - Day 1 was used to determine Quit Attempts', 'unitOfMeasure': 'Participants'}, {'title': 'Cigarette Consumption per Day', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}], 'categories': [{'title': '≤ 20', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}, {'title': '>20', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Day 7 IVRS data (or the last available data entered before the Day 8 site visit) were used to derive the Cigarette Consumption per day and it was in the randomization on Day 8', 'unitOfMeasure': 'Participants'}, {'title': 'Quit Attempts in previous 6 months', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.89', 'groupId': 'BG000'}, {'value': '0.2', 'spread': '0.67', 'groupId': 'BG001'}, {'value': '0.3', 'spread': '0.81', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Number of times stopped smoking cigarettes for 24 hours or longer in an attempt to quit in past 6 months', 'unitOfMeasure': 'smoking cessations', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Intent to Treat population. Data was not available for four subjects.'}, {'title': 'Number of years smoked since turning 21 years of age', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '19.5', 'spread': '10.99', 'groupId': 'BG000'}, {'value': '20.3', 'spread': '10.30', 'groupId': 'BG001'}, {'value': '19.8', 'spread': '10.69', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Intent to Treat population. Data was not available for three subjects.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-08-09', 'size': 945422, 'label': 'Study Protocol: COV-VER-01-13 Protocol Version 1', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-04-01T12:35', 'hasProtocol': True}, {'date': '2013-08-20', 'size': 732230, 'label': 'Study Protocol: COV-VER-01-13 Protocol Version 2', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-04-01T12:37', 'hasProtocol': True}, {'date': '2013-10-31', 'size': 433401, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-04-01T12:28', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 154}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2013-11-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-30', 'studyFirstSubmitDate': '2019-08-14', 'resultsFirstSubmitDate': '2023-08-08', 'studyFirstSubmitQcDate': '2019-09-04', 'lastUpdatePostDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-30', 'studyFirstPostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-11-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Summary Statistics of Percent Change From Baseline for Urinary Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) (%) (Per-Protocol Population)', 'timeFrame': 'Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)', 'description': "Summary statistics of percent change from baseline for urinary total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol \\[NNAL\\] (%) in each study visit are presented.\n\nBaseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1\n\nMean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a Statistical Analysis System (SAS®) procedure."}], 'secondaryOutcomes': [{'measure': 'Summary Statistics of Change From Baseline for Urinary Total NNAL (ng/g Creatinine) (Per-Protocol Population)', 'timeFrame': 'Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)', 'description': 'Summary statistics of change from baseline for urinary total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol \\[NNAL\\] (ng/g creatinine) in each study visit are presented.\n\nBaseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1'}, {'measure': 'Summary Statistics of Change From Baseline for Nicotine Equivalents (mg / g Creatinine) (Per-Protocol Population)', 'timeFrame': 'Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)', 'description': "Summary statistics of change from Baseline for urinary nicotine equivalents including nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide) (mg/g creatinine) in each study visit are presented.\n\nBaseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1"}, {'measure': 'Summary Statistics of Percent Change From Baseline for Nicotine Equivalents (%) (Per-Protocol Population)', 'timeFrame': 'Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)', 'description': "Summary statistics of percent change from Baseline for urinary nicotine equivalents including nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide) (%) in each study visit are presented.\n\nBaseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1\n\nMean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a SAS® procedure."}, {'measure': 'Summary Statistics of Change From Baseline for S-phenyl Mercapturic Acid (S-PMA) (ng/g Creatinine) (Per-Protocol Population)', 'timeFrame': 'Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)', 'description': 'Summary statistics of change from Baseline for urinary S-phenyl mercapturic acid \\[S-PMA\\] (ng/g creatinine) in each study visit are presented.\n\nBaseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1'}, {'measure': 'Summary Statistics of Percent Change From Baseline for S-PMA (%) (Per-Protocol Population)', 'timeFrame': 'Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)', 'description': "Summary statistics of percent change from Baseline for urinary S-phenyl mercapturic acid \\[S-PMA\\] (%) in each study visit are presented.\n\nBaseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1\n\nMean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a SAS® procedure."}, {'measure': 'Summary Statistics of Change From Baseline for Carboxyhemoglobin (%) (Per-Protocol Population)', 'timeFrame': 'Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)', 'description': 'Summary statistics of change from Baseline for blood carboxyhemoglobin (%) in each study visit are presented.\n\nBaseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1'}, {'measure': 'Summary Statistics of Percent Change From Baseline for Carboxyhemoglobin (%) (Per-Protocol Population)', 'timeFrame': 'Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)', 'description': "Summary statistics of percent change from Baseline for blood carboxyhemoglobin (%) in each study visit are presented.\n\nBaseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1\n\nMean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a SAS® procedure."}, {'measure': 'Summary Statistics of Change From Baseline for Exhaled Carbon Monoxide (Ppm) (Per-Protocol Population)', 'timeFrame': 'Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)', 'description': 'Summary statistics of change from Baseline for exhaled carbon monoxide (ppm) in each study visit are presented.\n\nBaseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1'}, {'measure': 'Summary Statistics of Percent Change From Baseline for Exhaled Carbon Monoxide (%) (Per-Protocol Population)', 'timeFrame': 'Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)', 'description': "Summary statistics of percent change from Baseline for exhaled carbon monoxide (%) in each study visit are presented.\n\nBaseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1\n\nMean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a SAS® procedure."}, {'measure': 'Summary Statistics of Change From Baseline in Cigarettes Smoked Per Day (Per-Protocol Population)', 'timeFrame': 'Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)', 'description': 'Summary statistics of change from Baseline in number or products used day in each study visit are presented.\n\nValues for visit are the average of daily values for the previous week Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1'}, {'measure': 'Summary Statistics of Percent Change From Baseline for Cigarettes Smoked Per Day (CPD) (Per-Protocol Population)', 'timeFrame': 'Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)', 'description': "Summary statistics of percent change from Baseline of number of products used per day in each study visit are presented.\n\nCPD was tracked using an interactive voice response system (IVRS). During the Baseline Period (Days 1 to 8), subjects reported CPD daily through an IVRS each day between 16:00 and 19:00. Test and Control subjects continued daily tobacco use tracking via an IVRS and return to the study site once a week during the 4 week Product Use Period on Days 15, 22, 29, and 36.\n\nMean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing the calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a SAS procedure."}, {'measure': 'Summary Statistics of Change From Baseline for Total Score of Fagerstrom Test for Cigarette Dependence (Per-Protocol Population)', 'timeFrame': 'Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)', 'description': "Summary statistics of change from Baseline for Total Score of Fagerstrom Test for Cigarette Dependence at the end of study/early termination are presented. The Fagerstrom Test for Nicotine Dependence consists of Yes/No and multiple-choice questions where each response is assigned a value from 0 to 1 (for yes/no questions) or 0 to 3 (for multiple-choice questions). Values are summed to yield a total score with a minimum score of 0 points and a maximum score of 10 points. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine.\n\nBaseline = Visit 3 (Day 8) value Population: Per-Protocol"}, {'measure': 'Count of Subjects in Subgroups Based on Change From Baseline to End of Study on Change in Quit Attempts (Per-Protocol)', 'timeFrame': 'Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)', 'description': 'Count of Test and Control subjects that reported an increase, decrease or no change in quit attempts from Baseline to End of Study are presented. Results for the number of self-reported attempts to quit smoking in the previous 30 days were collected from subject responses to the question "How many times during the past 30 days have you stopped smoking cigarettes for 24 hours or longer because you were trying to quit?".\n\nBaseline = Visit 2 values. Population: Per-Protocol.'}, {'measure': 'Count of Subjects in Subgroups Based on Change From Baseline to End of Study on Change in Quitting Intentions (Per-Protocol)', 'timeFrame': 'Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)', 'description': 'Count of Test and Control subjects that reported a change (No to Yes) or no change in quitting intentions from Baseline to End of Study are presented. Results were collected from subject Yes/No responses to the question "Are you planning to quit smoking in the next 30 days?".\n\nBaseline = Visit 2 responses. Population: Per-Protocol.'}, {'measure': 'Difference in Means of Urinary Total NNAL Exposure Between Day 1 and Day 8 (Per-Protocol)', 'timeFrame': 'Daily during Baseline Period (Day 1 to Day 8)', 'description': 'This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period.\n\nDifference in mean urinary total NNAL exposure between two methods for determining daily product use (Cigarettes Per Day \\[CPD\\]) during the Baseline Period:\n\nMethod 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1).\n\nMethod 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8).\n\nPopulation: Per-Protocol.'}, {'measure': 'Difference in Means of Nicotine Equivalents Exposure Between Day 1 and Day 8 (Per-Protocol)', 'timeFrame': 'Daily during Baseline Period (Day 1 to Day 8)', 'description': "This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period.\n\nDifference in mean urinary nicotine equivalents exposure between two methods for determining daily product use (Cigarettes Per Day \\[CPD\\]) during the Baseline Period:\n\nMethod 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1).\n\nMethod 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8).\n\nNicotine equivalents include nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide) Population: Per-Protocol."}, {'measure': 'Difference in Means of S-PMA Exposure Between Day 1 and Day 8 (Per-Protocol)', 'timeFrame': 'Daily during Baseline Period (Day 1 to Day 8)', 'description': 'This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period.\n\nDifference in mean urinary S-phenylmercapturic acid \\[S-PMA\\] exposure between two methods for determining daily product use (Cigarettes Per Day \\[CPD\\]) during the Baseline Period:\n\nMethod 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1).\n\nMethod 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8).\n\nPopulation: Per-Protocol.'}, {'measure': 'Difference in Means of Carboxyhemoglobin (COHb) Exposure Between Day 1 and Day 8 (Per-Protocol)', 'timeFrame': 'Daily during Baseline Period (Day 1 to Day 8)', 'description': 'This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period.\n\nDifference in mean blood carboxyhemoglobin \\[COHb\\] exposure between two methods for determining daily product use (Cigarettes Per Day \\[CPD\\]) during the Baseline Period:\n\nMethod 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1).\n\nMethod 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8).\n\nPopulation: Per-Protocol.'}, {'measure': 'Difference in Means of Carbon Monoxide (CO) Exposure Between Day 1 and Day 8 (Per-Protocol)', 'timeFrame': 'Daily during Baseline Period (Day 1 to Day 8)', 'description': 'This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period.\n\nDifference in mean exhaled carbon monoxide \\[CO\\] between two methods for determining daily product use (Cigarettes Per Day, CPD) during the Baseline Period:\n\nMethod 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1).\n\nMethod 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8).\n\nPopulation: Per-Protocol.'}, {'measure': 'Difference in Cigarettes Per Day Between the Once Weekly Recall at Day 8 (From Questionnaire) and the Average Daily Tracking Days 2 Through 8 (From IVRS) (Per-Protocol)', 'timeFrame': 'Daily during Baseline Period (Day 1 to Day 8)', 'description': 'This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period.\n\nDifference in product use (Cigarettes Per Day \\[CPD\\]), including test product, between two methods for determining CPD during the Baseline Period:\n\nMethod 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1).\n\nMethod 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8).\n\nPopulation: Per-Protocol.'}, {'measure': 'Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption', 'timeFrame': 'Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7)', 'description': "Change in cigarette consumption, categorized as 'No change', '\\<50% reduction', '50% to \\< 100% reduction', '100% reduction' or 'Increase', among subjects in Test and Control groups are presented. Baseline values are based on the average of daily values for the week prior to randomization (Visit 3/Day 8±1)."}, {'measure': 'Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine)', 'timeFrame': 'Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7)', 'description': "Change in Urinary Total NNAL, categorized as 'No change', 'Reduction', 'Increase' or 'Missing', among subjects in Test and Control groups are presented. Baseline values are Visit 3 (Day 8) values."}, {'measure': 'Frequency and Percentage of Subjects With Change From Baseline in Quitting Intentions', 'timeFrame': 'Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)', 'description': "Change in subject quitting intentions from Baseline to End of Study are presented. Subject responses were categorized as 'No to Yes', 'Yes to No' and 'Same' (no change in quitting intention). Baseline = Visit 2 (Day 1)"}, {'measure': 'Summary Statistics of Cigarettes Smoked Per Day on Visits 2 (Day 1) and 3 (Day 8)', 'timeFrame': 'Day 1 (Visit 2) and Day 8 (Visit 3)', 'description': 'Summary statistics of average cigarettes smoked per day \\[CPD\\] over previous 7 days collected from Cigarette Use questionnaire on Visit 2 (Day 1) and Visit 3 (Day 8) are presented.'}, {'measure': 'Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits', 'timeFrame': 'Day 1 (Visit 2), Day 8 (Visit 3), Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7)', 'description': "Summary statistics of blood carboxyhemoglobin in each visit among subjects in Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \\>50% Reduction', '50 to \\<100% Reduction', '100% Reduction' and 'Missing') are presented."}, {'measure': 'Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits', 'timeFrame': 'Day 1 (Visit 2), Day 8 (Visit 3), Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7)', 'description': "Summary Statistics of exhaled carbon monoxide in each visit among subjects in Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \\>50% Reduction', '50 to \\<100% Reduction', '100% Reduction' and 'Missing') are presented."}, {'measure': 'Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits', 'timeFrame': 'Day 1 (Visit 2), Day 8 (Visit 3), Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7)', 'description': "Summary statistics of urinary S-PMA (ng/g creatinine) in each visit among subjects in Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \\>50% Reduction', '50 to \\<100% Reduction', '100% Reduction' and 'Missing') are presented."}, {'measure': 'Descriptive Statistics for Cigarettes Smoked Per Day (CPD) (Recall Data) in Day 1 and 8 (Respectively) by Study Group and Cigarette Consumption Categories', 'timeFrame': 'Day 1 (Visit 2) and Day 8 (Visit 3)', 'description': "Descriptive statistics for Cigarettes Smoked per Day (CPD) in Day 1 (Visit 2) and Day 8 (Visit 3) in Test and Control groups using recall data are presented. Subjects were sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \\>50% Reduction', '50 to \\<100% Reduction', '100% Reduction' and 'Missing')."}, {'measure': 'Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8', 'timeFrame': 'Daily during Baseline Period (Day 1 to Day 8)', 'description': "Summary Statistics of Cigarettes Smoked per Day collected by IVRS Data method on Days 1 to 8 for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \\>50% Reduction', '50 to \\<100% Reduction', '100% Reduction' and 'Missing') are presented."}, {'measure': 'Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group', 'timeFrame': 'Day 8 (Visit 3) and End of Study (Day 36±1)', 'description': 'Median change from baseline to End of Study for urinary total NNAL in Test and Control groups are presented. Baseline = Day 8 (Visit 3) values.'}, {'measure': 'Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories', 'timeFrame': 'Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)', 'description': "Median Change from baseline to End of Study for urinary total NNAL in Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \\>50% Reduction', '50 to \\<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Day 8 (Visit 3) values"}, {'measure': 'Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits', 'timeFrame': 'Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)', 'description': "Change from Baseline to End of Study summary statistics of urinary total NNAL (ng/g Creatinine) by Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \\>50% Reduction', '50 to \\<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values."}, {'measure': 'Percent Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (%) by Study Group and Cigarette Consumption Categories Over Visits', 'timeFrame': 'Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)', 'description': "Percent change from Baseline to End of study summary statistics of urinary total NNAL (%) for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \\>50% Reduction', '50 to \\<100% Reduction', '100% Reduction' and 'Missing') are presented.\n\nBaseline = Visit 3 (Day 8) values."}, {'measure': 'Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (mg/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits', 'timeFrame': 'Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)', 'description': "Change from Baseline to End of Study summary statistics of urinary nicotine equivalents (mg/g creatinine) by Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \\>50% Reduction', '50 to \\<100% Reduction', '100% Reduction' and 'Missing') are presented.\n\nNicotine equivalents include nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide).\n\nBaseline = Visit 3 (Day 8) values."}, {'measure': 'Percent Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (%) by Study Group and Cigarette Consumption Categories Over Visits', 'timeFrame': 'Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)', 'description': "Percent change from Baseline to End of study summary statistics of urinary nicotine equivalents (%) for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \\>50% Reduction', '50 to \\<100% Reduction', '100% Reduction' and 'Missing') are presented.\n\nNicotine equivalents include nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide).\n\nBaseline = Visit 3 (Day 8) values."}, {'measure': 'Change From Baseline to End of Study Summary Statistics of S-PMA (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits', 'timeFrame': 'Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)', 'description': "Change from Baseline to End of Study summary statistics of urinary S-phenyl mercapturic acid \\[S-PMA\\] (ng/g creatinine) by Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \\>50% Reduction', '50 to \\<100% Reduction', '100% Reduction' and 'Missing') are presented.\n\nBaseline = Visit 3 (Day 8) values."}, {'measure': 'Percent Change From Baseline to End of Study Summary Statistics of S-PMA (%) by Study Group and Cigarette Consumption Categories Over Visits', 'timeFrame': 'Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)', 'description': "Percent change from Baseline to End of study summary statistics of urinary S-phenyl mercapturic acid \\[S-PMA\\] (%) for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \\>50% Reduction', '50 to \\<100% Reduction', '100% Reduction' and 'Missing') are presented.\n\nBaseline = Visit 3 (Day 8) values."}, {'measure': 'Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits', 'timeFrame': 'Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)', 'description': "Change from Baseline to End of Study summary statistics of blood carboxyhemoglobin (%) by Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \\>50% Reduction', '50 to \\<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values."}, {'measure': 'Percent Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits', 'timeFrame': 'Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)', 'description': "Percent change from Baseline to End of study summary statistics of blood carboxyhemoglobin (%) for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \\>50% Reduction', '50 to \\<100% Reduction', '100% Reduction' and 'Missing') are presented.\n\nBaseline = Visit 3 (Day 8) values."}, {'measure': 'Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (Ppm) by Study Group and Cigarette Consumption Categories Over Visits', 'timeFrame': 'Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)', 'description': "Change from Baseline to End of Study summary statistics of exhaled carbon monoxide (ppm) by Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \\>50% Reduction', '50 to \\<100% Reduction', '100% Reduction' and 'Missing') are presented.\n\nBaseline = Visit 3 (Day 8) values."}, {'measure': 'Percent Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (%) by Study Group and Cigarette Consumption Categories Over Visits', 'timeFrame': 'Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)', 'description': "Percent change from Baseline to End of study summary statistics of exhaled carbon monoxide for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \\>50% Reduction', '50 to \\<100% Reduction', '100% Reduction' and 'Missing') are presented.\n\nBaseline = Visit 3 (Day 8) values."}, {'measure': 'Characterization of Subgroups Based on Change From Baseline in Total NNAL', 'timeFrame': 'Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)', 'description': 'Statistical analyses on the number of subjects in subgroups based on urinary total NNAL change from baseline to the last visit are presented.\n\nBaseline = Visit 3 values.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tobacco Use']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to estimate changes in biomarkers of exposure (BOE) in adult cigarette smokers using an oral tobacco-derived nicotine (OTDN) product relative to adult smokers who continue smoking exclusively.', 'detailedDescription': 'This was a randomized, controlled, open-label, parallel group, multicenter, 9-week study to determine changes in BOE in adult smokers allowed ad libitum use of an OTDN product relative to adult smokers who were not allowed to use an OTDN product. This study was conducted in adult smokers who were considered to be in overall good health. Subjects were randomized to Test (allowed OTDN use) or Control (not allowed OTDN use) groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'genderBased': True, 'genderDescription': 'This study enrolled adult male and female (no more than 60% of either gender) self-affirmed combustible cigarette smokers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubject must:\n\n1. sign an Institutional Review Board (IRB)-approved Informed Consent Form (ICF) for the study.\n2. be between the ages of 21 and 65 years, inclusive, at the time of Screening.\n3. have consumed a minimum of 10 manufactured cigarettes per day (CPD) daily during the last 6 months (entire 6 month period must have occurred after subject turned 21 years of age).\n4. indicate that he/she smokes cigarettes "every day" at Screening and on Day 1\n5. be able to fully comprehend the English language.\n6. have an active phone number and must have daily access to a touchtone phone between 1600 and 1900 hours.\n7. be interested in alternative tobacco products to cigarettes at Screening.\n8. indicate that they "definitely would buy" or "probably would buy" on the VBM-FG2 Potential Purchase Interest Questionnaire.\n9. be in generally good health.\n10. if female, have a negative urine dipstick pregnancy test.\n11. if female heterosexually active and of childbearing potential (i.e., not surgically sterile or two years naturally postmenopausal), agree to use a medically accepted method of contraception from Screening through the End of Study.\n12. have clinical laboratory tests within the appropriate reference range or which are clinically acceptable to the Investigator.\n13. have a negative ethanol, amphetamines, opiates, cannabinoids, and cocaine urine drug screen.\n14. test negative for human immunodeficiency (HIV), hepatitis B (hepatitis B surface antigen \\[HBsAg\\]), and Hepatitis C (anti-hepatitis C virus antibody \\[anti-HCV\\]).\n15. be willing and able to comply with the requirements of the study.\n\nExclusion Criteria:\n\nSubject must not:\n\n1. be pregnant, nursing, or planning to become pregnant during the study period.\n2. indicate that he/she intends to quit smoking within the next 30 days (at Screening or on Day 1).\n3. have uncontrolled hypertension, history of coronary heart disease or other significant heart conditions, and/or other significant medical conditions that might interfere with study procedures.\n4. have used prescription anti-diabetic medication and/or insulin therapy within 12 months of Day 1.\n5. have a history of drug or alcohol abuse within the 24 months prior to Screening.\n6. have participated in a clinical study for an investigational drug, device, or biologic within 30 days prior to enrollment (Day 1).\n7. be a current user of nicotine replacement therapy (indicate every day or some days on Subject Screener/Tobacco History Questionnaire).\n8. be a current or former employee of the tobacco industry or a first-degree relative (e.g., parent, sibling, child) of a current or former employee of the tobacco industry.\n9. have been involved in the development of the study design/conduct or be a first-degree relative (e.g., parent, sibling, child) of someone involved in the development of the study design/conduct.\n10. be a current employee or personnel involved with the study at the study site.\n11. be currently participating in the study at a different study site (i.e., each subject can only be in the study population once).'}, 'identificationModule': {'nctId': 'NCT04079933', 'briefTitle': 'A Study to Evaluate Changes in Smokers Using An Oral Tobacco-Derived Nicotine Product', 'organization': {'class': 'INDUSTRY', 'fullName': 'Altria Client Services LLC'}, 'officialTitle': 'A Randomized, Controlled, Parallel Group Clinical Study of Cigarette Smokers Using an Innovative Oral Tobacco-derived Nicotine Product to Determine Impact on Cigarette Consumption and Biomarkers of Exposure', 'orgStudyIdInfo': {'id': 'COV-VER-01-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Group 1: Continue Smoking', 'description': 'Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks'}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: OTDN', 'description': 'Subjects were allowed to continue smoking their own brand of cigarettes ad libitum and provided the option to use an OTDN (specifically, VERVE® Discs Blue Mint \\[VBM-FG2\\]) also under ad libitum conditions', 'interventionNames': ['Other: Oral tobacco-derived nicotine product (OTDN)']}], 'interventions': [{'name': 'Oral tobacco-derived nicotine product (OTDN)', 'type': 'OTHER', 'otherNames': ['VERVE® Discs Blue Mint, VBM-FG2 oral discs'], 'armGroupLabels': ['Group 2: OTDN']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32117', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Covance Daytona Clinical Research Unit', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'zip': '47710', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Covance Evansville Clinical Research Unit', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '75247', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Covance Dallas Clinical Research Unit', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Jeffery S Edmiston, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Altria Client Services LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Altria Client Services LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}