Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-06 @ 3:59 AM
Study NCT ID:
NCT03364751
Status:
COMPLETED
Last Update Posted:
2023-01-30
First Post:
2017-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Switching From Cigarette Smoking to the Use of IQOS on Periodontitis Treatment Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D055113', 'term': 'Chronic Periodontitis'}, {'id': 'D010514', 'term': 'Periodontal Pocket'}, {'id': 'D014086', 'term': 'Tooth Mobility'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D000073865', 'term': 'Cigarette Smoking'}, {'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064424', 'term': 'Tobacco Use'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062789', 'term': 'Tobacco Products'}], 'ancestors': [{'id': 'D000074602', 'term': 'Smoking Devices'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.PMI@pmi.com', 'phone': '+41 58 242 11 11', 'title': 'Christelle Haziza, Director Clinical Science & Biostatistics', 'organization': 'Philip Morris Products S.A.'}, 'certainAgreement': {'otherDetails': "We confirm we have the contractual provisions in place which specify that in no event will the study site be allowed to disclose to any third party (or publicly release) any information obtained through the study without the CRO's prior written consent which in turn cannot provide such consent without Sponsor's approval unless such publication is made to satisfy regulatory requirements.\n\nThe Intellectual Property rights and research results from the present study belong to the Sponsor.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, for a total study duration of up to 31 weeks for each subject.', 'description': 'The safety population comprised the 179 subjects enrolled in the study, of which 172 subjects were randomized to the IQOS or Cigarette arms.\n\nAdverse events are reported according to subjects\' product exposure over the study period (Product Use Category, i.e., IQOS use; Cigarette use; Dual use; or Other use) as detailed in the "Arm/Group" (Reporting Groups) table.\n\nThe seven subjects who were enrolled but not randomized are included in the Cigarette group for adverse event reporting.', 'eventGroups': [{'id': 'EG000', 'title': 'IQOS', 'description': 'IQOS users (safety population)', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 25, 'seriousNumAtRisk': 70, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cigarette', 'description': 'Cigarette users (safety population; includes 7 subjects who were enrolled but not randomized and were considered to be in the cigarette users group)', 'otherNumAtRisk': 91, 'deathsNumAtRisk': 91, 'otherNumAffected': 29, 'seriousNumAtRisk': 91, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Dual', 'description': 'Dual users (safety population)', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 13, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Other', 'description': 'Other users (safety population)', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Tooth fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Procedural Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Oral papilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hyperaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Device breakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Device failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Gingival Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}], 'seriousEvents': [{'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Jaw cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Periodontal Pocket Depth (PD) Change From Baseline at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IQOS', 'description': 'IQOS Product Use Category'}, {'id': 'OG001', 'title': 'Cigarette', 'description': 'Cigarette Product Use Category'}, {'id': 'OG002', 'title': 'Dual User', 'description': 'Dual User Product Use Category'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.046', 'groupId': 'OG000', 'lowerLimit': '-1.194', 'upperLimit': '-0.898'}, {'value': '-1.114', 'groupId': 'OG001', 'lowerLimit': '-1.258', 'upperLimit': '-0.970'}, {'value': '-1.177', 'groupId': 'OG002', 'lowerLimit': '-1.399', 'upperLimit': '-0.956'}]}]}], 'analyses': [{'pValue': '0.297', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.068', 'ciLowerLimit': '-0.060', 'ciUpperLimit': '0.196', 'groupDescription': 'Month 6: Difference between Cigarette and IQOS', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.550', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.064', 'ciLowerLimit': '-0.273', 'ciUpperLimit': '0.146', 'groupDescription': 'Month 6: Difference between Cigarette and Dual Use', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'At 6 months', 'description': 'Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Mean Periodontal PD change from baseline will be measured in all sites with initial PD ≥ 4 mm, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.', 'unitOfMeasure': 'millimeters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements). The "Other" reporting group, which included one subject, was not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IQOS', 'description': 'IQOS Product Use Category - As Exposed Set'}, {'id': 'OG001', 'title': 'Cigarette', 'description': 'Cigarette Product Use Category - As Exposed Set'}, {'id': 'OG002', 'title': 'Dual User', 'description': 'Dual User Product Use Category - As Exposed Set'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.972', 'groupId': 'OG000', 'lowerLimit': '-1.120', 'upperLimit': '-0.824'}, {'value': '-1.016', 'groupId': 'OG001', 'lowerLimit': '-1.158', 'upperLimit': '-0.873'}, {'value': '-1.035', 'groupId': 'OG002', 'lowerLimit': '-1.257', 'upperLimit': '-0.814'}]}]}], 'analyses': [{'pValue': '0.502', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.043', 'ciLowerLimit': '-0.084', 'ciUpperLimit': '0.171', 'groupDescription': 'Month 3: Difference between Cigarette and IQOS', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.851', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.020', 'ciLowerLimit': '-0.229', 'ciUpperLimit': '0.189', 'groupDescription': 'Month 3: Difference between Cigarette and Dual Use', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At 3 months', 'description': 'Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Mean Periodontal PD change from baseline will be measured in all sites with initial PD ≥ 4 mm, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.', 'unitOfMeasure': 'millimeters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements). The "Other" reporting group, which included one subject, was not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IQOS', 'description': 'IQOS Product Use Category - As Exposed Set'}, {'id': 'OG001', 'title': 'Cigarette', 'description': 'Cigarette Product Use Category - As Exposed Set'}, {'id': 'OG002', 'title': 'Dual User', 'description': 'Dual User Product Use Category - As Exposed Set'}], 'classes': [{'title': 'Month 3: Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.820', 'groupId': 'OG000', 'lowerLimit': '-0.980', 'upperLimit': '-0.660'}, {'value': '-0.889', 'groupId': 'OG001', 'lowerLimit': '-1.043', 'upperLimit': '-0.736'}, {'value': '-0.865', 'groupId': 'OG002', 'lowerLimit': '-1.122', 'upperLimit': '-0.608'}]}]}, {'title': 'Month 6: Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.903', 'groupId': 'OG000', 'lowerLimit': '-1.064', 'upperLimit': '-0.743'}, {'value': '-0.995', 'groupId': 'OG001', 'lowerLimit': '-1.150', 'upperLimit': '-0.840'}, {'value': '-1.100', 'groupId': 'OG002', 'lowerLimit': '-1.357', 'upperLimit': '-0.843'}]}]}], 'analyses': [{'pValue': '0.376', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.070', 'ciLowerLimit': '-0.085', 'ciUpperLimit': '0.224', 'groupDescription': 'Month 3: Difference between Cigarette and IQOS', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.848', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.025', 'ciLowerLimit': '-0.229', 'ciUpperLimit': '0.279', 'groupDescription': 'Month 3: Difference between Cigarette and DualUse', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.246', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.092', 'ciLowerLimit': '-0.064', 'ciUpperLimit': '0.247', 'groupDescription': 'Month 6: Difference between Cigarette and IQOS', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.417', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.105', 'ciLowerLimit': '-0.359', 'ciUpperLimit': '0.150', 'groupDescription': 'Month 6: Difference between Cigarette and Dual Use', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'At 3 months and 6 months', 'description': 'Clinical attachment level (CAL) is the measured distance from cementoenamel junction (CEJ) to the bottom of pocket using a periodontal probe. Mean CAL change from baseline will be measured in sites with initial PD ≥ 4 mm, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.', 'unitOfMeasure': 'millimeters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements). The "Other" reporting group, which included one subject, was not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'IQOS', 'description': 'IQOS Product Use Category - As Exposed Set'}, {'id': 'OG001', 'title': 'Cigarette', 'description': 'Cigarette Product Use Category - As Exposed Set'}, {'id': 'OG002', 'title': 'Dual User', 'description': 'Dual User Product Use Category - As Exposed Set'}, {'id': 'OG003', 'title': 'Other', 'description': 'Other Product Use Category'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.45', 'groupId': 'OG000', 'lowerLimit': '4.34', 'upperLimit': '4.56'}, {'value': '4.43', 'groupId': 'OG001', 'lowerLimit': '4.35', 'upperLimit': '4.51'}, {'value': '4.34', 'groupId': 'OG002', 'lowerLimit': '4.25', 'upperLimit': '4.44'}, {'value': '4.07', 'groupId': 'OG003'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.44', 'groupId': 'OG000', 'lowerLimit': '3.28', 'upperLimit': '3.60'}, {'value': '3.47', 'groupId': 'OG001', 'lowerLimit': '3.34', 'upperLimit': '3.60'}, {'value': '4.34', 'groupId': 'OG002', 'lowerLimit': '4.25', 'upperLimit': '4.44'}, {'value': '3.04', 'groupId': 'OG003'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.36', 'groupId': 'OG000', 'lowerLimit': '3.20', 'upperLimit': '3.52'}, {'value': '3.37', 'groupId': 'OG001', 'lowerLimit': '3.23', 'upperLimit': '3.51'}, {'value': '3.29', 'groupId': 'OG002', 'lowerLimit': '3.03', 'upperLimit': '3.54'}, {'value': '3.09', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline to 3 months and 6 months', 'description': 'Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Mean Periodontal PD change from baseline will be measured in all sites with initial PD ≥ 4 mm, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.', 'unitOfMeasure': 'millimeters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).'}, {'type': 'SECONDARY', 'title': 'Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'IQOS', 'description': 'IQOS Product Use Category - As Exposed Set'}, {'id': 'OG001', 'title': 'Cigarette', 'description': 'Cigarette Product Use Category - As Exposed Set'}, {'id': 'OG002', 'title': 'Dual User', 'description': 'Dual User Product Use Category - As Exposed Set'}, {'id': 'OG003', 'title': 'Other', 'description': 'Other Product Use Category - As Exposed Set'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.65', 'groupId': 'OG000', 'lowerLimit': '4.45', 'upperLimit': '4.84'}, {'value': '4.64', 'groupId': 'OG001', 'lowerLimit': '4.45', 'upperLimit': '4.82'}, {'value': '4.60', 'groupId': 'OG002', 'lowerLimit': '4.36', 'upperLimit': '4.85'}, {'value': '4.13', 'groupId': 'OG003'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.82', 'groupId': 'OG000', 'lowerLimit': '3.57', 'upperLimit': '4.07'}, {'value': '3.79', 'groupId': 'OG001', 'lowerLimit': '3.57', 'upperLimit': '4.01'}, {'value': '3.87', 'groupId': 'OG002', 'lowerLimit': '3.48', 'upperLimit': '4.26'}, {'value': '3.20', 'groupId': 'OG003'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.74', 'groupId': 'OG000', 'lowerLimit': '3.48', 'upperLimit': '3.99'}, {'value': '3.69', 'groupId': 'OG001', 'lowerLimit': '3.46', 'upperLimit': '3.91'}, {'value': '3.64', 'groupId': 'OG002', 'lowerLimit': '3.24', 'upperLimit': '4.04'}, {'value': '3.21', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to 3 months and 6 months', 'description': 'Clinical attachment level (CAL) is the measured distance from cementoenamel junction (CEJ) to the bottom of pocket using a periodontal probe. Mean CAL change from baseline will be measured in sites with initial PD ≥ 4 mm, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.', 'unitOfMeasure': 'millimeters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).'}, {'type': 'SECONDARY', 'title': 'Full-mouth Periodontal PD Change Over Time.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'IQOS', 'description': 'IQOS Product Use Category - As Exposed Set'}, {'id': 'OG001', 'title': 'Cigarette', 'description': 'Cigarette Product Use Category - As Exposed Set'}, {'id': 'OG002', 'title': 'Dual User', 'description': 'Dual User Product Use Category - As Exposed Set'}, {'id': 'OG003', 'title': 'Other', 'description': 'Other Product Use Category - As Exposed Set'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.15', 'groupId': 'OG000', 'lowerLimit': '3.02', 'upperLimit': '3.29'}, {'value': '3.20', 'groupId': 'OG001', 'lowerLimit': '3.09', 'upperLimit': '3.31'}, {'value': '2.99', 'groupId': 'OG002', 'lowerLimit': '2.80', 'upperLimit': '3.17'}, {'value': '2.92', 'groupId': 'OG003'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.70', 'groupId': 'OG000', 'lowerLimit': '2.59', 'upperLimit': '2.81'}, {'value': '2.78', 'groupId': 'OG001', 'lowerLimit': '2.67', 'upperLimit': '2.88'}, {'value': '2.69', 'groupId': 'OG002', 'lowerLimit': '2.50', 'upperLimit': '2.88'}, {'value': '2.57', 'groupId': 'OG003'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.70', 'groupId': 'OG000', 'lowerLimit': '2.58', 'upperLimit': '2.82'}, {'value': '2.72', 'groupId': 'OG001', 'lowerLimit': '2.60', 'upperLimit': '2.84'}, {'value': '2.62', 'groupId': 'OG002', 'lowerLimit': '2.39', 'upperLimit': '2.84'}, {'value': '2.55', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to 3 months and 6 months', 'description': 'Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Change in mean full-mouth PD will be measured, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.', 'unitOfMeasure': 'millimeters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).'}, {'type': 'SECONDARY', 'title': 'Full-mouth Clinical Attachment Level (CAL) Over Time.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'IQOS', 'description': 'IQOS Product Use Category - As Exposed Set'}, {'id': 'OG001', 'title': 'Cigarette', 'description': 'Cigarette Product Use Category - As Exposed Set'}, {'id': 'OG002', 'title': 'Dual User', 'description': 'Dual User Product Use Category - As Exposed Set'}, {'id': 'OG003', 'title': 'Other', 'description': 'Other Product Use Category - As Exposed Set'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.48', 'groupId': 'OG000', 'lowerLimit': '3.26', 'upperLimit': '3.69'}, {'value': '3.52', 'groupId': 'OG001', 'lowerLimit': '3.34', 'upperLimit': '3.71'}, {'value': '3.34', 'groupId': 'OG002', 'lowerLimit': '3.00', 'upperLimit': '3.69'}, {'value': '2.99', 'groupId': 'OG003'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.10', 'groupId': 'OG000', 'lowerLimit': '2.88', 'upperLimit': '3.31'}, {'value': '3.13', 'groupId': 'OG001', 'lowerLimit': '2.93', 'upperLimit': '3.32'}, {'value': '3.15', 'groupId': 'OG002', 'lowerLimit': '2.75', 'upperLimit': '3.54'}, {'value': '2.70', 'groupId': 'OG003'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.10', 'groupId': 'OG000', 'lowerLimit': '2.86', 'upperLimit': '3.33'}, {'value': '3.09', 'groupId': 'OG001', 'lowerLimit': '2.89', 'upperLimit': '3.29'}, {'value': '2.97', 'groupId': 'OG002', 'lowerLimit': '2.59', 'upperLimit': '3.36'}, {'value': '2.70', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to 3 months and 6 months', 'description': 'Clinical attachment level (CAL) is the measured distance from cementoenamel junction (CEJ) to the bottom of pocket using a periodontal probe. Change in mean full-mouth CAL will be measured, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.', 'unitOfMeasure': 'millimeters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).'}, {'type': 'SECONDARY', 'title': 'Peridontal PD Reduction.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'IQOS', 'description': 'IQOS Product Use Category - As Exposed Set'}, {'id': 'OG001', 'title': 'Cigarette', 'description': 'Cigarette Product Use Category - As Exposed Set'}, {'id': 'OG002', 'title': 'Dual User', 'description': 'Dual User Product Use Category - As Exposed Set'}, {'id': 'OG003', 'title': 'Other', 'description': 'Other Product Use Category - As Exposed Set'}], 'classes': [{'title': '<4mm (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '2.6'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '2.6'}, {'value': '2.5', 'groupId': 'OG002', 'lowerLimit': '2.4', 'upperLimit': '2.6'}, {'value': '2.6', 'groupId': 'OG003'}]}]}, {'title': '<4mm (Month 3: Change from Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '-0.1'}, {'value': '-0.2', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '-0.1'}, {'value': '-0.1', 'groupId': 'OG002', 'lowerLimit': '-0.2', 'upperLimit': '0.0'}, {'value': '-0.1', 'groupId': 'OG003'}]}]}, {'title': '<4mm (Month 6: Change from Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '-0.1'}, {'value': '-0.2', 'groupId': 'OG001', 'lowerLimit': '-0.3', 'upperLimit': '-0.2'}, {'value': '-0.1', 'groupId': 'OG002', 'lowerLimit': '-0.3', 'upperLimit': '0.0'}, {'value': '-0.1', 'groupId': 'OG003'}]}]}, {'title': '4mm-5mm (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '4.0'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '4.0'}, {'value': '4.0', 'groupId': 'OG002', 'lowerLimit': '4.0', 'upperLimit': '4.0'}, {'value': '4.0', 'groupId': 'OG003'}]}]}, {'title': '4mm-5mm (Month 3: Change from Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'groupId': 'OG000', 'lowerLimit': '-0.9', 'upperLimit': '-0.7'}, {'value': '-0.8', 'groupId': 'OG001', 'lowerLimit': '-0.9', 'upperLimit': '-0.7'}, {'value': '-0.8', 'groupId': 'OG002', 'lowerLimit': '-0.9', 'upperLimit': '-0.6'}, {'value': '-1.0', 'groupId': 'OG003'}]}]}, {'title': '4mm-5mm (Month 6: Change from Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '-0.8'}, {'value': '-0.9', 'groupId': 'OG001', 'lowerLimit': '-1.0', 'upperLimit': '-0.8'}, {'value': '-0.8', 'groupId': 'OG002', 'lowerLimit': '-1.1', 'upperLimit': '-0.6'}, {'value': '-0.9', 'groupId': 'OG003'}]}]}, {'title': '5mm-6mm (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '5.0'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '5.0'}, {'value': '5.0', 'groupId': 'OG002', 'lowerLimit': '5.0', 'upperLimit': '5.0'}, {'value': '5.0', 'groupId': 'OG003'}]}]}, {'title': '5mm-6mm (Month 3: Change from Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'groupId': 'OG000', 'lowerLimit': '-1.3', 'upperLimit': '-1.0'}, {'value': '-1.1', 'groupId': 'OG001', 'lowerLimit': '-1.2', 'upperLimit': '-0.9'}, {'value': '-1.0', 'groupId': 'OG002', 'lowerLimit': '-1.3', 'upperLimit': '-0.7'}, {'value': '-1.8', 'groupId': 'OG003'}]}]}, {'title': '5mm-6mm (Month 6: Change from Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'groupId': 'OG000', 'lowerLimit': '-1.4', 'upperLimit': '-1.0'}, {'value': '-1.2', 'groupId': 'OG001', 'lowerLimit': '-1.4', 'upperLimit': '-1.1'}, {'value': '-1.2', 'groupId': 'OG002', 'lowerLimit': '-1.6', 'upperLimit': '-0.9'}, {'value': '-2.0', 'groupId': 'OG003'}]}]}, {'title': '6mm-7mm (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '6.0'}, {'value': '6.0', 'groupId': 'OG001', 'lowerLimit': '6.0', 'upperLimit': '6.0'}, {'value': '6.0', 'groupId': 'OG002', 'lowerLimit': '6.0', 'upperLimit': '6.0'}, {'value': 'NA', 'comment': 'The sole subject in this use category did not have any sites with a PD ≥6mm.', 'groupId': 'OG003'}]}]}, {'title': '6mm-7mm (Month 3: Change from Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'groupId': 'OG000', 'lowerLimit': '-1.6', 'upperLimit': '-1.0'}, {'value': '-1.2', 'groupId': 'OG001', 'lowerLimit': '-1.4', 'upperLimit': '-0.9'}, {'value': '-1.4', 'groupId': 'OG002', 'lowerLimit': '-2.0', 'upperLimit': '-0.8'}, {'value': 'NA', 'comment': 'The sole subject in this use category did not have any sites with a PD ≥6mm.', 'groupId': 'OG003'}]}]}, {'title': '6mm-7mm (Month 6: Change from Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'groupId': 'OG000', 'lowerLimit': '-1.8', 'upperLimit': '-1.3'}, {'value': '-1.4', 'groupId': 'OG001', 'lowerLimit': '-1.6', 'upperLimit': '-1.2'}, {'value': '-1.8', 'groupId': 'OG002', 'lowerLimit': '-2.3', 'upperLimit': '-1.3'}, {'value': 'NA', 'comment': 'The sole subject in this use category did not have any sites with a PD ≥6mm.', 'groupId': 'OG003'}]}]}, {'title': '≥7mm (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000', 'lowerLimit': '7.3', 'upperLimit': '7.9'}, {'value': '7.5', 'groupId': 'OG001', 'lowerLimit': '7.3', 'upperLimit': '7.6'}, {'value': '8.4', 'groupId': 'OG002', 'lowerLimit': '6.7', 'upperLimit': '10.1'}, {'value': 'NA', 'comment': 'The sole subject in this use category did not have any sites with a PD ≥6mm.', 'groupId': 'OG003'}]}]}, {'title': '≥7mm (Month 3: Change from Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'groupId': 'OG000', 'lowerLimit': '-2.5', 'upperLimit': '-1.6'}, {'value': '-1.6', 'groupId': 'OG001', 'lowerLimit': '-2.0', 'upperLimit': '-1.1'}, {'value': '-2.5', 'groupId': 'OG002', 'lowerLimit': '-3.6', 'upperLimit': '-1.3'}, {'value': 'NA', 'comment': 'The sole subject in this use category did not have any sites with a PD ≥6mm.', 'groupId': 'OG003'}]}]}, {'title': '≥7mm (Month 6: Change from Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'groupId': 'OG000', 'lowerLimit': '-2.9', 'upperLimit': '-1.7'}, {'value': '-1.7', 'groupId': 'OG001', 'lowerLimit': '-2.1', 'upperLimit': '-1.3'}, {'value': '-2.3', 'groupId': 'OG002', 'lowerLimit': '-3.4', 'upperLimit': '-1.3'}, {'value': 'NA', 'comment': 'The sole subject in this use category did not have any sites with a PD ≥6mm.', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to 3 months and 6 months', 'description': 'Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Mean PD change will be measured in sites with initial PD \\< 4 mm, and with initial PD of 4 mm to \\<5 mm, 5 mm to \\< 6 mm, 6 mm to \\< 7 mm and ≥ 7 mm.', 'unitOfMeasure': 'millimeters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).'}, {'type': 'SECONDARY', 'title': 'Clinical Attachment Level Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'IQOS', 'description': 'IQOS Product Use Category - As Exposed Set'}, {'id': 'OG001', 'title': 'Cigarette', 'description': 'Cigarette Product Use Category - As Exposed Set'}, {'id': 'OG002', 'title': 'Dual User', 'description': 'Dual User Product Use Category - As Exposed Set'}, {'id': 'OG003', 'title': 'Other', 'description': 'Other Product Use Category - As Exposed Set'}], 'classes': [{'title': '<4mm (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '3.1'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '3.1'}, {'value': '2.9', 'groupId': 'OG002', 'lowerLimit': '2.6', 'upperLimit': '3.3'}, {'value': '2.6', 'groupId': 'OG003'}]}]}, {'title': '<4mm (Month 3: Change from Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '-0.1'}, {'value': '-0.2', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '-0.1'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-0.2', 'upperLimit': '0.1'}, {'value': '-0.1', 'groupId': 'OG003'}]}]}, {'title': '<4mm (Month 6: Change from Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '0.0'}, {'value': '-0.2', 'groupId': 'OG001', 'lowerLimit': '-0.3', 'upperLimit': '-0.1'}, {'value': '-0.2', 'groupId': 'OG002', 'lowerLimit': '-0.4', 'upperLimit': '0.0'}, {'value': '-0.1', 'groupId': 'OG003'}]}]}, {'title': '4mm-5mm (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '4.4'}, {'value': '4.2', 'groupId': 'OG001', 'lowerLimit': '4.1', 'upperLimit': '4.4'}, {'value': '4.3', 'groupId': 'OG002', 'lowerLimit': '4.1', 'upperLimit': '4.6'}, {'value': '4.1', 'groupId': 'OG003'}]}]}, {'title': '4mm-5mm (Month 3: Change from Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'groupId': 'OG000', 'lowerLimit': '-0.8', 'upperLimit': '-0.6'}, {'value': '-0.7', 'groupId': 'OG001', 'lowerLimit': '-0.8', 'upperLimit': '-0.6'}, {'value': '-0.6', 'groupId': 'OG002', 'lowerLimit': '-0.8', 'upperLimit': '-0.4'}, {'value': '-0.9', 'groupId': 'OG003'}]}]}, {'title': '4mm-5mm (Month 6: Change from Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'groupId': 'OG000', 'lowerLimit': '-0.9', 'upperLimit': '-0.6'}, {'value': '-0.8', 'groupId': 'OG001', 'lowerLimit': '-0.9', 'upperLimit': '-0.7'}, {'value': '-0.8', 'groupId': 'OG002', 'lowerLimit': '-1.0', 'upperLimit': '-0.5'}, {'value': '-0.9', 'groupId': 'OG003'}]}]}, {'title': '5mm-6mm (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '5.3'}, {'value': '5.2', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '5.3'}, {'value': '5.2', 'groupId': 'OG002', 'lowerLimit': '5.1', 'upperLimit': '5.4'}, {'value': '5.0', 'groupId': 'OG003'}]}]}, {'title': '5mm-6mm (Month 3: Change from Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'groupId': 'OG000', 'lowerLimit': '-1.1', 'upperLimit': '-0.8'}, {'value': '-1.0', 'groupId': 'OG001', 'lowerLimit': '-1.1', 'upperLimit': '-0.8'}, {'value': '-0.8', 'groupId': 'OG002', 'lowerLimit': '-1.1', 'upperLimit': '-0.4'}, {'value': '-1.2', 'groupId': 'OG003'}]}]}, {'title': '5mm-6mm (Month 6: Change from Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'groupId': 'OG000', 'lowerLimit': '-1.2', 'upperLimit': '-0.8'}, {'value': '-1.1', 'groupId': 'OG001', 'lowerLimit': '-1.3', 'upperLimit': '-0.9'}, {'value': '-1.2', 'groupId': 'OG002', 'lowerLimit': '-1.6', 'upperLimit': '-0.7'}, {'value': '-1.8', 'groupId': 'OG003'}]}]}, {'title': '6mm-7mm (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '6.5'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '6.1', 'upperLimit': '6.5'}, {'value': '6.3', 'groupId': 'OG002', 'lowerLimit': '6.0', 'upperLimit': '6.6'}, {'value': 'NA', 'comment': 'The sole subject in this use category did not have any sites with a PD ≥6mm.', 'groupId': 'OG003'}]}]}, {'title': '6mm-7mm (Month 3: Change from Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'groupId': 'OG000', 'lowerLimit': '-1.4', 'upperLimit': '-0.7'}, {'value': '-1.0', 'groupId': 'OG001', 'lowerLimit': '-1.3', 'upperLimit': '-0.7'}, {'value': '-1.2', 'groupId': 'OG002', 'lowerLimit': '-1.9', 'upperLimit': '-0.4'}, {'value': 'NA', 'comment': 'The sole subject in this use category did not have any sites with a PD ≥6mm.', 'groupId': 'OG003'}]}]}, {'title': '6mm-7mm (Month 6: Change from Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'groupId': 'OG000', 'lowerLimit': '-1.6', 'upperLimit': '-0.9'}, {'value': '-1.3', 'groupId': 'OG001', 'lowerLimit': '-1.5', 'upperLimit': '-1.0'}, {'value': '-1.7', 'groupId': 'OG002', 'lowerLimit': '-2.2', 'upperLimit': '-1.2'}, {'value': 'NA', 'comment': 'The sole subject in this use category did not have any sites with a PD ≥6mm.', 'groupId': 'OG003'}]}]}, {'title': '≥7mm (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000', 'lowerLimit': '6.9', 'upperLimit': '8.1'}, {'value': '7.9', 'groupId': 'OG001', 'lowerLimit': '7.6', 'upperLimit': '8.2'}, {'value': '8.8', 'groupId': 'OG002', 'lowerLimit': '6.4', 'upperLimit': '11.2'}, {'value': 'NA', 'comment': 'The sole subject in this use category did not have any sites with a PD ≥6mm.', 'groupId': 'OG003'}]}]}, {'title': '≥7mm (Month 3: Change from Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'groupId': 'OG000', 'lowerLimit': '-1.9', 'upperLimit': '-0.8'}, {'value': '-1.7', 'groupId': 'OG001', 'lowerLimit': '-2.1', 'upperLimit': '-1.3'}, {'value': '-1.6', 'groupId': 'OG002', 'lowerLimit': '-3.3', 'upperLimit': '0.1'}, {'value': 'NA', 'comment': 'The sole subject in this use category did not have any sites with a PD ≥6mm.', 'groupId': 'OG003'}]}]}, {'title': '≥7mm (Month 6: Change from Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.6', 'groupId': 'OG000', 'lowerLimit': '-2.2', 'upperLimit': '-0.9'}, {'value': '-1.9', 'groupId': 'OG001', 'lowerLimit': '-2.2', 'upperLimit': '-1.5'}, {'value': '-2.0', 'groupId': 'OG002', 'lowerLimit': '-4.0', 'upperLimit': '0.1'}, {'value': 'NA', 'comment': 'The sole subject in this use category did not have any sites with a PD ≥6mm.', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to 3 months and 6 months', 'description': 'Clinical attachment level (CAL) is the measured distance from cementoenamel junction (CEJ) to the bottom of pocket using a periodontal probe. Mean CAL change will be measured in sites with initial PD \\< 4 mm, and with initial PD of 4 mm to \\<5 mm, 5 mm to \\< 6 mm, 6 mm to \\< 7 mm and ≥ 7 mm.', 'unitOfMeasure': 'millimeters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).'}, {'type': 'SECONDARY', 'title': 'Number of Periodontally Diseased Sites.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'IQOS', 'description': 'IQOS Product Use Category - As Exposed Set'}, {'id': 'OG001', 'title': 'Cigarette', 'description': 'Cigarette Product Use Category - As Exposed Set'}, {'id': 'OG002', 'title': 'Dual User', 'description': 'Dual User Product Use Category - As Exposed Set'}, {'id': 'OG003', 'title': 'Other', 'description': 'Other Product Use Category - As Exposed Set'}], 'classes': [{'title': '<4mm: Baseline', 'categories': [{'measurements': [{'value': '7688', 'groupId': 'OG000'}, {'value': '9194', 'groupId': 'OG001'}, {'value': '1911', 'groupId': 'OG002'}, {'value': '127', 'groupId': 'OG003'}]}]}, {'title': '<4mm: Month 3', 'categories': [{'measurements': [{'value': '9332', 'groupId': 'OG000'}, {'value': '11146', 'groupId': 'OG001'}, {'value': '2181', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}]}, {'title': '<4mm: Month 6', 'categories': [{'measurements': [{'value': '9241', 'groupId': 'OG000'}, {'value': '11199', 'groupId': 'OG001'}, {'value': '2227', 'groupId': 'OG002'}, {'value': '159', 'groupId': 'OG003'}]}]}, {'title': '4mm - 5mm: Baseline', 'categories': [{'measurements': [{'value': '2067', 'groupId': 'OG000'}, {'value': '2571', 'groupId': 'OG001'}, {'value': '469', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}]}, {'title': '4mm - 5mm: Month 3', 'categories': [{'measurements': [{'value': '1037', 'groupId': 'OG000'}, {'value': '1393', 'groupId': 'OG001'}, {'value': '261', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': '4mm - 5mm: Month 6', 'categories': [{'measurements': [{'value': '934', 'groupId': 'OG000'}, {'value': '1241', 'groupId': 'OG001'}, {'value': '259', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': '5mm - 6mm: Baseline', 'categories': [{'measurements': [{'value': '724', 'groupId': 'OG000'}, {'value': '1042', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': '5mm - 6mm: Month 3', 'categories': [{'measurements': [{'value': '366', 'groupId': 'OG000'}, {'value': '483', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '5mm - 6mm: Month 6', 'categories': [{'measurements': [{'value': '333', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': '6mm - 7mm: Baseline', 'categories': [{'measurements': [{'value': '291', 'groupId': 'OG000'}, {'value': '333', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '6mm - 7mm: Month 3', 'categories': [{'measurements': [{'value': '151', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '6mm - 7mm: Month 6', 'categories': [{'measurements': [{'value': '189', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '≥7mm: Baseline', 'categories': [{'measurements': [{'value': '220', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '≥7mm: Month 3', 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '≥7mm: Month 6', 'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Missing/Not done: Baseline', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Missing/Not done: Month 3', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Missing/Not done: Month 6', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to 3 months and 6 months', 'description': 'Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Any change will be recorded in the number of periodontally diseased sites with Pocket Depth (PD) \\< 4 mm, with PD 4 mm to \\< 5mm, with PD 5 mm to \\< 6 mm , with PD 6 mm to \\< 7 mm and with PD ≥ 7 mm. PD is the distance from the gingival margin to which a probe penetrates into the pocket.', 'unitOfMeasure': 'Number of sites', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).'}, {'type': 'SECONDARY', 'title': 'Gingival Inflammation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'IQOS', 'description': 'IQOS Product Use Category - As Exposed Set'}, {'id': 'OG001', 'title': 'Cigarette', 'description': 'Cigarette Product Use Category - As Exposed Set'}, {'id': 'OG002', 'title': 'Dual User', 'description': 'Dual User Product Use Category - As Exposed Set'}, {'id': 'OG003', 'title': 'Other', 'description': 'Other Product Use Category - As Exposed Set'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.46', 'groupId': 'OG000', 'lowerLimit': '1.35', 'upperLimit': '1.57'}, {'value': '1.48', 'groupId': 'OG001', 'lowerLimit': '1.40', 'upperLimit': '1.56'}, {'value': '1.46', 'groupId': 'OG002', 'lowerLimit': '1.28', 'upperLimit': '1.64'}, {'value': '1.38', 'groupId': 'OG003'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.06', 'groupId': 'OG000', 'lowerLimit': '0.93', 'upperLimit': '1.20'}, {'value': '1.08', 'groupId': 'OG001', 'lowerLimit': '0.97', 'upperLimit': '1.19'}, {'value': '1.22', 'groupId': 'OG002', 'lowerLimit': '1.01', 'upperLimit': '1.44'}, {'value': '0.5', 'groupId': 'OG003'}]}]}, {'title': 'Month 3: Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.40', 'groupId': 'OG000', 'lowerLimit': '-0.52', 'upperLimit': '-0.28'}, {'value': '-0.40', 'groupId': 'OG001', 'lowerLimit': '-0.51', 'upperLimit': '-0.29'}, {'value': '-0.24', 'groupId': 'OG002', 'lowerLimit': '-0.44', 'upperLimit': '-0.03'}, {'value': '-0.88', 'groupId': 'OG003'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.03', 'groupId': 'OG000', 'lowerLimit': '0.90', 'upperLimit': '1.17'}, {'value': '1.04', 'groupId': 'OG001', 'lowerLimit': '0.93', 'upperLimit': '1.15'}, {'value': '1.05', 'groupId': 'OG002', 'lowerLimit': '0.87', 'upperLimit': '1.23'}, {'value': '1.38', 'groupId': 'OG003'}]}]}, {'title': 'Month 6: Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.43', 'groupId': 'OG000', 'lowerLimit': '-0.55', 'upperLimit': '-0.30'}, {'value': '-0.44', 'groupId': 'OG001', 'lowerLimit': '-0.56', 'upperLimit': '-0.31'}, {'value': '-0.41', 'groupId': 'OG002', 'lowerLimit': '-0.67', 'upperLimit': '-0.15'}, {'value': '0.00', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to 3 months and 6 months', 'description': 'Gingival inflammation will be measured by calculating the gingival index (GI) score for each target tooth.\n\nThe gingival index (GI) scores each site on a 0 to 3 scale, with 0 being normal and 3 being severe inflammation characterized by edema, redness, swelling, and spontaneous bleeding.', 'unitOfMeasure': 'Gingival Index (GI)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).'}, {'type': 'SECONDARY', 'title': 'Tooth Mobility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'IQOS', 'description': 'IQOS Product Use Category - As Exposed Set'}, {'id': 'OG001', 'title': 'Cigarette', 'description': 'Cigarette Product Use Category - As Exposed Set'}, {'id': 'OG002', 'title': 'Dual User', 'description': 'Dual User Product Use Category - As Exposed Set'}, {'id': 'OG003', 'title': 'Other', 'description': 'Other Product Use Category - As Exposed Set'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.18', 'groupId': 'OG000', 'lowerLimit': '0.11', 'upperLimit': '0.24'}, {'value': '0.19', 'groupId': 'OG001', 'lowerLimit': '0.12', 'upperLimit': '0.26'}, {'value': '0.23', 'groupId': 'OG002', 'lowerLimit': '0.06', 'upperLimit': '0.40'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.17', 'groupId': 'OG000', 'lowerLimit': '0.10', 'upperLimit': '0.24'}, {'value': '0.16', 'groupId': 'OG001', 'lowerLimit': '0.09', 'upperLimit': '0.22'}, {'value': '0.19', 'groupId': 'OG002', 'lowerLimit': '0.03', 'upperLimit': '0.34'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Month 3: Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.01', 'groupId': 'OG000', 'lowerLimit': '-0.03', 'upperLimit': '0.02'}, {'value': '-0.03', 'groupId': 'OG001', 'lowerLimit': '-0.06', 'upperLimit': '-0.01'}, {'value': '-0.04', 'groupId': 'OG002', 'lowerLimit': '-0.12', 'upperLimit': '0.04'}, {'value': '0.00', 'groupId': 'OG003'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.18', 'groupId': 'OG000', 'lowerLimit': '0.10', 'upperLimit': '0.26'}, {'value': '0.17', 'groupId': 'OG001', 'lowerLimit': '0.09', 'upperLimit': '0.24'}, {'value': '0.16', 'groupId': 'OG002', 'lowerLimit': '0.04', 'upperLimit': '0.27'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Month 6: Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.04', 'upperLimit': '0.04'}, {'value': '-0.02', 'groupId': 'OG001', 'lowerLimit': '-0.05', 'upperLimit': '0.01'}, {'value': '-0.07', 'groupId': 'OG002', 'lowerLimit': '-0.15', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to 3 months and 6 months', 'description': "Tooth mobility will be graded according to Miller's mobility index (MMI), which is the most widely accepted method for routine clinical examinations of tooth mobility. The tooth is held between the metallic handles of two instruments and moved in the buccolingual or buccopalatal direction, and the moved distance is visually estimated by the person conducting the examination.\n\nGrade 0: Physiologic movement within 0.2 mm; Grade 1: Slight mobility, tooth can be moved 0.2 - 1 mm labiolingually; Grade 2: Moderate mobility, tooth can be moved 1 - 2 mm labiolingually or mesiodistally; Grade 3: Severe mobility, tooth can be moved more than 2 mm labiolingually or mesiodistally, or ability to depress the tooth in a vertical direction.", 'unitOfMeasure': 'MMI', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).'}, {'type': 'SECONDARY', 'title': 'Presence of Plaque on Tooth Surfaces in Full Mouth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'IQOS', 'description': 'IQOS Product Use Category - As Exposed Set'}, {'id': 'OG001', 'title': 'Cigarette', 'description': 'Cigarette Product Use Category - As Exposed Set'}, {'id': 'OG002', 'title': 'Dual User', 'description': 'Dual User Product Use Category - As Exposed Set'}, {'id': 'OG003', 'title': 'Other', 'description': 'Other Product Use Category - As Exposed Set'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '62.07', 'groupId': 'OG000', 'lowerLimit': '57.68', 'upperLimit': '66.46'}, {'value': '62.48', 'groupId': 'OG001', 'lowerLimit': '57.92', 'upperLimit': '67.03'}, {'value': '55.81', 'groupId': 'OG002', 'lowerLimit': '44.62', 'upperLimit': '67.99'}, {'value': '77.68', 'groupId': 'OG003'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '48.03', 'groupId': 'OG000', 'lowerLimit': '43.08', 'upperLimit': '52.97'}, {'value': '50.14', 'groupId': 'OG001', 'lowerLimit': '45.66', 'upperLimit': '54.62'}, {'value': '44.56', 'groupId': 'OG002', 'lowerLimit': '34.08', 'upperLimit': '55.04'}, {'value': '60.71', 'groupId': 'OG003'}]}]}, {'title': 'Month 3: Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-14.27', 'groupId': 'OG000', 'lowerLimit': '-19.04', 'upperLimit': '-9.49'}, {'value': '-12.34', 'groupId': 'OG001', 'lowerLimit': '-15.70', 'upperLimit': '-8.99'}, {'value': '-11.25', 'groupId': 'OG002', 'lowerLimit': '-21.45', 'upperLimit': '-1.05'}, {'value': '-16.96', 'groupId': 'OG003'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '49.60', 'groupId': 'OG000', 'lowerLimit': '44.24', 'upperLimit': '54.96'}, {'value': '51.55', 'groupId': 'OG001', 'lowerLimit': '47.20', 'upperLimit': '55.90'}, {'value': '47.92', 'groupId': 'OG002', 'lowerLimit': '37.57', 'upperLimit': '58.28'}, {'value': '58.04', 'groupId': 'OG003'}]}]}, {'title': 'Month 6: Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-13.27', 'groupId': 'OG000', 'lowerLimit': '-18.14', 'upperLimit': '-8.41'}, {'value': '-11.22', 'groupId': 'OG001', 'lowerLimit': '-14.72', 'upperLimit': '-7.71'}, {'value': '-7.89', 'groupId': 'OG002', 'lowerLimit': '-17.75', 'upperLimit': '1.98'}, {'value': '-19.64', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to 3 months and 6 months', 'description': 'Plaque will be measured using the plaque control record (PCR) percentage.', 'unitOfMeasure': 'Plaque Control Record %', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).'}, {'type': 'SECONDARY', 'title': 'Inflammatory Status in Periodontal Pockets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'IQOS', 'description': 'IQOS Product Use Category - As Exposed Set'}, {'id': 'OG001', 'title': 'Cigarette', 'description': 'Cigarette Product Use Category - As Exposed Set'}, {'id': 'OG002', 'title': 'Dual User', 'description': 'Dual User Product Use Category - As Exposed Set'}, {'id': 'OG003', 'title': 'Other', 'description': 'Other Product Use Category - As Exposed Set'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '41.25', 'groupId': 'OG000', 'lowerLimit': '35.94', 'upperLimit': '46.56'}, {'value': '42.93', 'groupId': 'OG001', 'lowerLimit': '38.33', 'upperLimit': '47.52'}, {'value': '30.80', 'groupId': 'OG002', 'lowerLimit': '23.96', 'upperLimit': '37.65'}, {'value': '48.81', 'groupId': 'OG003'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '26.68', 'groupId': 'OG000', 'lowerLimit': '22.30', 'upperLimit': '31.06'}, {'value': '24.21', 'groupId': 'OG001', 'lowerLimit': '20.70', 'upperLimit': '27.71'}, {'value': '19.03', 'groupId': 'OG002', 'lowerLimit': '15.49', 'upperLimit': '22.56'}, {'value': '53.57', 'groupId': 'OG003'}]}]}, {'title': 'Month 3: Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-14.57', 'groupId': 'OG000', 'lowerLimit': '-19.03', 'upperLimit': '-10.11'}, {'value': '-18.72', 'groupId': 'OG001', 'lowerLimit': '-21.84', 'upperLimit': '-15.60'}, {'value': '-11.78', 'groupId': 'OG002', 'lowerLimit': '-16.48', 'upperLimit': '-7.07'}, {'value': '4.76', 'groupId': 'OG003'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '26.90', 'groupId': 'OG000', 'lowerLimit': '22.70', 'upperLimit': '31.09'}, {'value': '23.80', 'groupId': 'OG001', 'lowerLimit': '20.10', 'upperLimit': '27.50'}, {'value': '19.80', 'groupId': 'OG002', 'lowerLimit': '13.33', 'upperLimit': '26.28'}, {'value': '38.10', 'groupId': 'OG003'}]}]}, {'title': 'Month 6: Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-14.85', 'groupId': 'OG000', 'lowerLimit': '-19.16', 'upperLimit': '-10.54'}, {'value': '-18.71', 'groupId': 'OG001', 'lowerLimit': '-22.33', 'upperLimit': '-15.10'}, {'value': '-11.00', 'groupId': 'OG002', 'lowerLimit': '-16.83', 'upperLimit': '-5.17'}, {'value': '-10.71', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to 3 months and 6 months', 'description': 'Gum inflammation was measured using percentage of teeth bleeding on probing (BOP).\n\nBOP in full mouth was measured to assess inflammatory status in the pocket and was assessed as YES or NO of bleeding at 6 sites per tooth. Gently probing (approximately 20 g pressure), the bleeding site within 30 seconds was assessed as YES.', 'unitOfMeasure': 'BOP %', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).'}, {'type': 'SECONDARY', 'title': 'Concentrations of Urinary Nicotine Equivalents (NEQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'IQOS', 'description': 'IQOS Product Use Category - As Exposed Set'}, {'id': 'OG001', 'title': 'Cigarette', 'description': 'Cigarette Product Use Category - As Exposed Set'}, {'id': 'OG002', 'title': 'Dual User', 'description': 'Dual User Product Use Category - As Exposed Set'}, {'id': 'OG003', 'title': 'Other', 'description': 'Other Product Use Category - As Exposed Set'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.777', 'groupId': 'OG000', 'lowerLimit': '5.625', 'upperLimit': '8.165'}, {'value': '7.649', 'groupId': 'OG001', 'lowerLimit': '6.756', 'upperLimit': '8.661'}, {'value': '6.452', 'groupId': 'OG002', 'lowerLimit': '3.935', 'upperLimit': '10.580'}, {'value': '8.527', 'groupId': 'OG003'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.766', 'groupId': 'OG000', 'lowerLimit': '5.611', 'upperLimit': '8.158'}, {'value': '6.699', 'groupId': 'OG001', 'lowerLimit': '5.620', 'upperLimit': '7.986'}, {'value': '5.911', 'groupId': 'OG002', 'lowerLimit': '3.820', 'upperLimit': '9.146'}, {'value': '7.681', 'groupId': 'OG003'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.471', 'groupId': 'OG000', 'lowerLimit': '5.235', 'upperLimit': '7.999'}, {'value': '6.563', 'groupId': 'OG001', 'lowerLimit': '5.337', 'upperLimit': '8.071'}, {'value': '5.467', 'groupId': 'OG002', 'lowerLimit': '3.044', 'upperLimit': '9.816'}, {'value': '5.213', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From baseline to 3 months and 6 months', 'description': 'This biomarker of exposure to a tobacco smoke constituent will be measured in patients who switch to IQOS use and patients who continue cigarette smoking. Concentrations measured in urine and expressed as concentration adjusted for creatinine (mg/g creat).', 'unitOfMeasure': 'mg/g creat', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).'}, {'type': 'SECONDARY', 'title': 'Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'IQOS', 'description': 'IQOS Product Use Category - As Exposed Set'}, {'id': 'OG001', 'title': 'Cigarette', 'description': 'Cigarette Product Use Category - As Exposed Set'}, {'id': 'OG002', 'title': 'Dual User', 'description': 'Dual User Product Use Category - As Exposed Set'}, {'id': 'OG003', 'title': 'Other', 'description': 'Other Product Use Category - As Exposed Set'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '83.30', 'groupId': 'OG000', 'lowerLimit': '65.33', 'upperLimit': '106.20'}, {'value': '112.52', 'groupId': 'OG001', 'lowerLimit': '92.19', 'upperLimit': '137.35'}, {'value': '93.01', 'groupId': 'OG002', 'lowerLimit': '58.11', 'upperLimit': '148.84'}, {'value': '159.05', 'groupId': 'OG003'}]}]}, {'title': 'Mionth 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '25.77', 'groupId': 'OG000', 'lowerLimit': '20.03', 'upperLimit': '33.16'}, {'value': '100.67', 'groupId': 'OG001', 'lowerLimit': '80.95', 'upperLimit': '125.20'}, {'value': '68.62', 'groupId': 'OG002', 'lowerLimit': '39.17', 'upperLimit': '120.23'}, {'value': '124.39', 'groupId': 'OG003'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '22.55', 'groupId': 'OG000', 'lowerLimit': '17.28', 'upperLimit': '29.45'}, {'value': '96.70', 'groupId': 'OG001', 'lowerLimit': '75.97', 'upperLimit': '123.09'}, {'value': '77.17', 'groupId': 'OG002', 'lowerLimit': '45.80', 'upperLimit': '130.03'}, {'value': '48.74', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From baseline to 3 months and 6 months', 'description': 'This biomarker of exposure to a tobacco smoke constituent will be measured in patients who switch to IQOS use and patients who continue cigarette smoking. Concentrations measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat).', 'unitOfMeasure': 'pg/mg creat', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).'}, {'type': 'SECONDARY', 'title': 'Concentrations of 2-cyanoethylmercapturic Acid (CEMA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'IQOS', 'description': 'IQOS Product Use Category - As Exposed Set'}, {'id': 'OG001', 'title': 'Cigarette', 'description': 'Cigarette Product Use Category - As Exposed Set'}, {'id': 'OG002', 'title': 'Dual User', 'description': 'Dual User Product Use Category - As Exposed Set'}, {'id': 'OG003', 'title': 'Other', 'description': 'Other Product Use Category - As Exposed Set'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '67.29', 'groupId': 'OG000', 'lowerLimit': '52.25', 'upperLimit': '86.67'}, {'value': '90.44', 'groupId': 'OG001', 'lowerLimit': '74.00', 'upperLimit': '110.54'}, {'value': '92.10', 'groupId': 'OG002', 'lowerLimit': '59.04', 'upperLimit': '143.66'}, {'value': '140.95', 'groupId': 'OG003'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.94', 'groupId': 'OG000', 'lowerLimit': '7.35', 'upperLimit': '13.43'}, {'value': '80.30', 'groupId': 'OG001', 'lowerLimit': '63.38', 'upperLimit': '101.74'}, {'value': '50.36', 'groupId': 'OG002', 'lowerLimit': '27.16', 'upperLimit': '93.41'}, {'value': '5.19', 'groupId': 'OG003'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.56', 'groupId': 'OG000', 'lowerLimit': '5.53', 'upperLimit': '10.33'}, {'value': '76.65', 'groupId': 'OG001', 'lowerLimit': '59.37', 'upperLimit': '98.97'}, {'value': '69.02', 'groupId': 'OG002', 'lowerLimit': '37.51', 'upperLimit': '127.01'}, {'value': '1.97', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From baseline to 3 months and 6 months', 'description': 'This biomarker of exposure to a tobacco smoke constituent will be measured in patients who switch to IQOS use and patients who continue cigarette smoking. Concentrations measured in urine and expressed as concentration adjusted for creatinine (ng/mg creat).', 'unitOfMeasure': 'ng/mg creat', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).'}, {'type': 'SECONDARY', 'title': 'Use of Tobacco or Nicotine-containing Products in Patients Switching to IQOS Use and Patients Who Continue Cigarette Smoking.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'IQOS', 'description': 'IQOS Product Use Category - As Exposed Set'}, {'id': 'OG001', 'title': 'Cigarette', 'description': 'Cigarette Product Use Category - As Exposed Set'}, {'id': 'OG002', 'title': 'Dual User', 'description': 'Dual User Product Use Category - As Exposed Set'}, {'id': 'OG003', 'title': 'Other', 'description': 'Other Product Use Category - As Exposed Set'}], 'classes': [{'title': 'Cigarettes/day over the last five years (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000', 'lowerLimit': '16.7', 'upperLimit': '19.7'}, {'value': '17.7', 'groupId': 'OG001', 'lowerLimit': '16.6', 'upperLimit': '18.9'}, {'value': '18.1', 'groupId': 'OG002', 'lowerLimit': '15.1', 'upperLimit': '21.1'}, {'value': '20.0', 'groupId': 'OG003'}]}]}, {'title': 'Cigarettes/day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.22', 'groupId': 'OG000', 'lowerLimit': '0.10', 'upperLimit': '0.34'}, {'value': '17.06', 'groupId': 'OG001', 'lowerLimit': '15.77', 'upperLimit': '18.35'}, {'value': '8.16', 'groupId': 'OG002', 'lowerLimit': '3.58', 'upperLimit': '12.73'}]}]}, {'title': 'IQOS Heatsticks/day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16.60', 'groupId': 'OG000', 'lowerLimit': '15.19', 'upperLimit': '18.02'}, {'value': '0.30', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '3.51'}, {'value': '9.06', 'groupId': 'OG002', 'lowerLimit': '6.86', 'upperLimit': '11.25'}]}]}, {'title': 'Other Heat-Not-Burn/day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.67', 'groupId': 'OG000'}, {'value': '3.72', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '14.24'}, {'value': '0.01', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '0.04'}, {'value': '30.00', 'groupId': 'OG003'}]}]}, {'title': 'E-cigarettes/day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.67', 'groupId': 'OG000'}]}]}, {'title': 'Nicotine Replacement Therapy/day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.81', 'groupId': 'OG001'}, {'value': '0.50', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to 6 months', 'description': 'Self-reported use of tobacco or nicotine containing products will be measured over the study in patients switching to IQOS use and patients who continue cigarette smoking.', 'unitOfMeasure': 'number of product units consumed', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment analyzed by actual product use. Results were reported only for subjects with exposure to a specific tobacco or nicotine-containing product.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IQOS', 'description': 'IQOS Product Use Category:\n\nSubjects using over 30 HeatSticks, but less than 30 cigarettes monthly were classified as "IQOS" users (based on self-report).'}, {'id': 'FG001', 'title': 'Cigarette', 'description': 'Cigarette Product Use Category:\n\nMonthly users of less than 30 HeatSticks, but over 30 cigarettes were classified as "Cigarette" users (based on self-report).'}, {'id': 'FG002', 'title': 'Dual User', 'description': 'Dual User Product Use Category:\n\nUsers of over 30 HeatSticks and over 30 cigarettes per month were classified as "Dual User" (based on self-report).'}, {'id': 'FG003', 'title': 'Other', 'description': 'Other Product Use Category:\n\nAll other use patterns were classified as "Other" (based on self-report).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '84'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '83'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '179 subjects were enrolled in the study. 172 subjects were randomized to the IQOS arm (n=87) or to the cigarette arm (n=85).\n\nThe analysis was performed according to subjects\' exposure (Product Use Category, i.e., IQOS; Cigarette; Dual use; or Other) over the study period as detailed in the "Arm/Group" (Reporting Groups) table.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '172', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'IQOS', 'description': 'IQOS Product Use Category'}, {'id': 'BG001', 'title': 'Cigarette', 'description': 'Cigarette Product Use Category'}, {'id': 'BG002', 'title': 'Dual User', 'description': 'Dual User Product Use Category'}, {'id': 'BG003', 'title': 'Other', 'description': 'Other Product Use Category'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.1', 'groupId': 'BG000', 'lowerLimit': '30', 'upperLimit': '71'}, {'value': '46.5', 'groupId': 'BG001', 'lowerLimit': '30', 'upperLimit': '77'}, {'value': '54.4', 'groupId': 'BG002', 'lowerLimit': '33', 'upperLimit': '73'}, {'value': '54.0', 'groupId': 'BG003', 'lowerLimit': '54', 'upperLimit': '54'}, {'value': '48.0', 'groupId': 'BG004', 'lowerLimit': '30', 'upperLimit': '77'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '139', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '172', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '172', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Nationality', 'classes': [{'categories': [{'title': 'Japanese', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '172', 'groupId': 'BG004'}]}, {'title': 'Non-Japanese', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Subjects using during the course of this study over 30 HeatSticks, but less than 30 cigarettes monthly were classified as "IQOS" users. Monthly users of less than 30 HeatSticks, but over 30 cigarettes were classified as "Cigarette" users. Users of over 30 HeatSticks and over 30 cigarettes per month were classified as "Dual User". All other use patterns were classified as "Other".'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-09', 'size': 3159772, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-06-17T10:18', 'hasProtocol': True}, {'date': '2019-06-07', 'size': 1888725, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-06-17T10:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'The Dentist (Investigator) or Dental Hygienist performing the periodontal assessments will be blinded to the arm allocation.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 179}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2019-06-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-26', 'studyFirstSubmitDate': '2017-11-23', 'resultsFirstSubmitDate': '2020-11-11', 'studyFirstSubmitQcDate': '2017-12-01', 'lastUpdatePostDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-27', 'studyFirstPostDateStruct': {'date': '2017-12-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Periodontal Pocket Depth (PD) Change From Baseline at 6 Months', 'timeFrame': 'At 6 months', 'description': 'Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Mean Periodontal PD change from baseline will be measured in all sites with initial PD ≥ 4 mm, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.'}], 'secondaryOutcomes': [{'measure': 'Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm)', 'timeFrame': 'At 3 months', 'description': 'Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Mean Periodontal PD change from baseline will be measured in all sites with initial PD ≥ 4 mm, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.'}, {'measure': 'Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm)', 'timeFrame': 'At 3 months and 6 months', 'description': 'Clinical attachment level (CAL) is the measured distance from cementoenamel junction (CEJ) to the bottom of pocket using a periodontal probe. Mean CAL change from baseline will be measured in sites with initial PD ≥ 4 mm, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.'}, {'measure': 'Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics', 'timeFrame': 'From baseline to 3 months and 6 months', 'description': 'Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Mean Periodontal PD change from baseline will be measured in all sites with initial PD ≥ 4 mm, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.'}, {'measure': 'Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics', 'timeFrame': 'From baseline to 3 months and 6 months', 'description': 'Clinical attachment level (CAL) is the measured distance from cementoenamel junction (CEJ) to the bottom of pocket using a periodontal probe. Mean CAL change from baseline will be measured in sites with initial PD ≥ 4 mm, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.'}, {'measure': 'Full-mouth Periodontal PD Change Over Time.', 'timeFrame': 'From baseline to 3 months and 6 months', 'description': 'Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Change in mean full-mouth PD will be measured, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.'}, {'measure': 'Full-mouth Clinical Attachment Level (CAL) Over Time.', 'timeFrame': 'From baseline to 3 months and 6 months', 'description': 'Clinical attachment level (CAL) is the measured distance from cementoenamel junction (CEJ) to the bottom of pocket using a periodontal probe. Change in mean full-mouth CAL will be measured, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.'}, {'measure': 'Peridontal PD Reduction.', 'timeFrame': 'From baseline to 3 months and 6 months', 'description': 'Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Mean PD change will be measured in sites with initial PD \\< 4 mm, and with initial PD of 4 mm to \\<5 mm, 5 mm to \\< 6 mm, 6 mm to \\< 7 mm and ≥ 7 mm.'}, {'measure': 'Clinical Attachment Level Improvement', 'timeFrame': 'From baseline to 3 months and 6 months', 'description': 'Clinical attachment level (CAL) is the measured distance from cementoenamel junction (CEJ) to the bottom of pocket using a periodontal probe. Mean CAL change will be measured in sites with initial PD \\< 4 mm, and with initial PD of 4 mm to \\<5 mm, 5 mm to \\< 6 mm, 6 mm to \\< 7 mm and ≥ 7 mm.'}, {'measure': 'Number of Periodontally Diseased Sites.', 'timeFrame': 'From baseline to 3 months and 6 months', 'description': 'Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Any change will be recorded in the number of periodontally diseased sites with Pocket Depth (PD) \\< 4 mm, with PD 4 mm to \\< 5mm, with PD 5 mm to \\< 6 mm , with PD 6 mm to \\< 7 mm and with PD ≥ 7 mm. PD is the distance from the gingival margin to which a probe penetrates into the pocket.'}, {'measure': 'Gingival Inflammation', 'timeFrame': 'From baseline to 3 months and 6 months', 'description': 'Gingival inflammation will be measured by calculating the gingival index (GI) score for each target tooth.\n\nThe gingival index (GI) scores each site on a 0 to 3 scale, with 0 being normal and 3 being severe inflammation characterized by edema, redness, swelling, and spontaneous bleeding.'}, {'measure': 'Tooth Mobility', 'timeFrame': 'From baseline to 3 months and 6 months', 'description': "Tooth mobility will be graded according to Miller's mobility index (MMI), which is the most widely accepted method for routine clinical examinations of tooth mobility. The tooth is held between the metallic handles of two instruments and moved in the buccolingual or buccopalatal direction, and the moved distance is visually estimated by the person conducting the examination.\n\nGrade 0: Physiologic movement within 0.2 mm; Grade 1: Slight mobility, tooth can be moved 0.2 - 1 mm labiolingually; Grade 2: Moderate mobility, tooth can be moved 1 - 2 mm labiolingually or mesiodistally; Grade 3: Severe mobility, tooth can be moved more than 2 mm labiolingually or mesiodistally, or ability to depress the tooth in a vertical direction."}, {'measure': 'Presence of Plaque on Tooth Surfaces in Full Mouth', 'timeFrame': 'From baseline to 3 months and 6 months', 'description': 'Plaque will be measured using the plaque control record (PCR) percentage.'}, {'measure': 'Inflammatory Status in Periodontal Pockets', 'timeFrame': 'From baseline to 3 months and 6 months', 'description': 'Gum inflammation was measured using percentage of teeth bleeding on probing (BOP).\n\nBOP in full mouth was measured to assess inflammatory status in the pocket and was assessed as YES or NO of bleeding at 6 sites per tooth. Gently probing (approximately 20 g pressure), the bleeding site within 30 seconds was assessed as YES.'}, {'measure': 'Concentrations of Urinary Nicotine Equivalents (NEQ)', 'timeFrame': 'From baseline to 3 months and 6 months', 'description': 'This biomarker of exposure to a tobacco smoke constituent will be measured in patients who switch to IQOS use and patients who continue cigarette smoking. Concentrations measured in urine and expressed as concentration adjusted for creatinine (mg/g creat).'}, {'measure': 'Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL)', 'timeFrame': 'From baseline to 3 months and 6 months', 'description': 'This biomarker of exposure to a tobacco smoke constituent will be measured in patients who switch to IQOS use and patients who continue cigarette smoking. Concentrations measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat).'}, {'measure': 'Concentrations of 2-cyanoethylmercapturic Acid (CEMA)', 'timeFrame': 'From baseline to 3 months and 6 months', 'description': 'This biomarker of exposure to a tobacco smoke constituent will be measured in patients who switch to IQOS use and patients who continue cigarette smoking. Concentrations measured in urine and expressed as concentration adjusted for creatinine (ng/mg creat).'}, {'measure': 'Use of Tobacco or Nicotine-containing Products in Patients Switching to IQOS Use and Patients Who Continue Cigarette Smoking.', 'timeFrame': 'From baseline to 6 months', 'description': 'Self-reported use of tobacco or nicotine containing products will be measured over the study in patients switching to IQOS use and patients who continue cigarette smoking.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oral Health', 'Smoking', 'Cigarette', 'Reduced risk product', 'Tobacco heating system', 'THS', 'Modified risk tobacco product', 'Clinical attachment level'], 'conditions': ['Periodontal Diseases', 'Chronic Periodontitis', 'Periodontal Pocket', 'Tooth Mobility', 'Gingival Diseases', 'Smoking, Cigarette']}, 'referencesModule': {'references': [{'pmid': '33459599', 'type': 'BACKGROUND', 'citation': 'Pouly S, Ng WT, Benzimra M, Soulan A, Blanc N, Zanetti F, Picavet P, Baker G, Haziza C. Effect of Switching to the Tobacco Heating System Versus Continued Cigarette Smoking on Chronic Generalized Periodontitis Treatment Outcome: Protocol for a Randomized Controlled Multicenter Study. JMIR Res Protoc. 2021 Jan 18;10(1):e15350. doi: 10.2196/15350.'}, {'type': 'RESULT', 'citation': 'Effect of switching from cigarette smoking to the use of the tobacco heating system on periodontitis treatment outcome: Periodontal parameter results from a multicenter Japanese study Authors: Pouly, Sandrine; Ng, Wee Teck; Blanc, Nicolas; Hession, Paul; Zanetti, Filippo; Battey, James N. D.; de La Bourdonnaye, Guillaume; Heremans, Annie; Haziza, Christelle Journal Title: Frontiers in dental medicine Publication Date: 7/22/2022 Volume: 3 DOI: 10.3389/fdmed.2022.915079'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to demonstrate in patients with generalized chronic periodontitis that switching from cigarette smoking to using IQOS improves the response to periodontal therapy and the overall oral health status compared to continuing cigarette smoking.\n\nNote: "IQOS" is the Tobacco Heating System (THS) with Marlboro Heatsticks, marketed in Japan under the brand name IQOS', 'detailedDescription': 'This was a randomized, controlled, open-label, 2-arm, parallel group ambulatory study with the randomization stratified by daily cigarette consumption over the month (30 days) prior to Visit 1 (10-19 cigarettes/day vs. \\> 19 cigarettes/day) and disease severity recorded at Visit 1 (\\< 5 mm Pocket Depth \\[PD\\] vs. ≥ 5 mm PD) based on the most severely diseased tooth, in smokers with generalized chronic periodontitis who are randomized to either switch from cigarette smoking to IQOS use or continuing cigarette smoking.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n1. Patient is aged ≥ 30 years old.\n2. Patient has smoked on average at least 10 commercially available cigarettes per day for at least 5 years\n3. Patient has generalized chronic periodontitis (i.e., more than 30% of diseased teeth with a PD ≥ 4 mm).\n\nMain Exclusion Criteria:\n\n1. Patient has self-reported history of diagnosed systemic diseases (e.g., stroke or acute cardiovascular event within the last 5 years, diabetes, active cancer).\n2. Patient received root planing therapy within the 6 months prior to Visit 1.\n3. Patient received surgical periodontal therapy within 3 years prior to Visit\n4. Patient was treated within the 3 months prior to Visit 1 with systemic antibiotics or was treated with topical antibiotics applied in the mouth.\n5. Continuous systemic use of steroidal or non-steroidal anti-inflammatory drugs for more than 20 days during the past 30-day period (except for low dose aspirin, i.e., ≤300 mg).\n6. Female patients who are pregnant, breast-feeding, or planning a pregnancy within the course of the study.'}, 'identificationModule': {'nctId': 'NCT03364751', 'briefTitle': 'Effect of Switching From Cigarette Smoking to the Use of IQOS on Periodontitis Treatment Outcome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Philip Morris Products S.A.'}, 'officialTitle': 'A 6-month Randomized, Controlled, Open-label, 2-arm Parallel Group, Multicenter Study to Evaluate the Effect of Switching From Cigarette Smoking to the Use of IQOS in Smokers With Generalized Chronic Periodontitis on the Response to Mechanical Periodontal Treatment and Oral Health Status.', 'orgStudyIdInfo': {'id': 'P1-OHS-01-JP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'IQOS arm', 'description': '\\~86 patients, switching from cigarette smoking to IQOS use.', 'interventionNames': ['Other: IQOS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cigarette arm', 'description': '\\~86 patients, continuing cigarette smoking.', 'interventionNames': ['Other: Cigarette']}], 'interventions': [{'name': 'IQOS', 'type': 'OTHER', 'description': 'Patients will switch from cigarette smoking to ad libitum IQOS use.', 'armGroupLabels': ['IQOS arm']}, {'name': 'Cigarette', 'type': 'OTHER', 'description': 'Patients will continue to smoke cigarettes ad libitum.', 'armGroupLabels': ['Cigarette arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '293-0001', 'city': 'Futtsu', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Mase Dental Clinic', 'geoPoint': {'lat': 35.3108, 'lon': 139.81877}}, {'zip': '275-0016', 'city': 'Narashino', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Tsudanuma Olive Dental Clinic', 'geoPoint': {'lat': 35.68184, 'lon': 140.04152}}, {'zip': '800-0323', 'city': 'Miyako', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Matsunobu Dental Office', 'geoPoint': {'lat': 33.6992, 'lon': 130.92007}}, {'zip': '003-0023', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Taniguchi Dental Clinic', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '308- 0031', 'city': 'Chikusei', 'state': 'Ibaraki', 'country': 'Japan', 'facility': 'Takano Dental Clinic', 'geoPoint': {'lat': 36.316, 'lon': 139.98238}}, {'zip': '305-0834', 'city': 'Tsukuba', 'state': 'Ibaraki', 'country': 'Japan', 'facility': 'Tsukuba Healthcare Dental Clinic', 'geoPoint': {'lat': 36.08333, 'lon': 140.11667}}, {'zip': '210-0822', 'city': 'Kawasaki', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'AOI Universal Hospital', 'geoPoint': {'lat': 35.52056, 'lon': 139.71722}}, {'zip': '869-0521', 'city': 'Uki', 'state': 'Kumamoto', 'country': 'Japan', 'facility': 'Yoshinaga Dental Office', 'geoPoint': {'lat': 32.62217, 'lon': 130.66177}}, {'zip': '332-0016', 'city': 'Kawaguchi', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Yoshino Dental Clinic', 'geoPoint': {'lat': 35.80521, 'lon': 139.71072}}, {'zip': '359-1146', 'city': 'Tokorozawa', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Saida Dental Clinic', 'geoPoint': {'lat': 35.79916, 'lon': 139.46903}}, {'zip': '113-0033', 'city': 'Bunkyō', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Sakai Dental Clinic'}, {'zip': '102-0074', 'city': 'Chiyoda City', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Kudan Dental Clinic', 'geoPoint': {'lat': 35.68449, 'lon': 139.75056}}, {'zip': '182-0024', 'city': 'Chōfu', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Yano Dental Clinic', 'geoPoint': {'lat': 35.65924, 'lon': 139.54837}}, {'zip': '103-0027', 'city': 'Chūō', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Nikaido Dental Clinic', 'geoPoint': {'lat': 35.67004, 'lon': 139.77544}}, {'zip': '157-0072', 'city': 'Setagaya City', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Mune Dental Clinic', 'geoPoint': {'lat': 35.64188, 'lon': 139.64715}}, {'zip': '160-0023', 'city': 'Shinjuku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Kikuchi Dental Clinic', 'geoPoint': {'lat': 35.69115, 'lon': 139.70854}}, {'zip': '171-0043', 'city': 'Toshima City', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Miyata Dental Clinic', 'geoPoint': {'lat': 35.76126, 'lon': 139.74491}}, {'zip': '935-0015', 'city': 'Himi', 'state': 'Toyama', 'country': 'Japan', 'facility': 'Kato Dental Clinic', 'geoPoint': {'lat': 36.84666, 'lon': 136.98355}}, {'zip': '810-0001', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Kimura Dental Clinic', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '810-0001', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Yamashita Dental Office', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '810-0001', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Yasumasu Dental Office', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '811-1302', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Tsukiyama Dental Clinic', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '812-0011', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Yoshida Shigeru Dental Office', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '890-0053', 'city': 'Kagoshima', 'country': 'Japan', 'facility': 'Yamashita Dental Clinic', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'zip': '892-0844', 'city': 'Kagoshima', 'country': 'Japan', 'facility': 'Heart Dental Clinic', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'zip': '860-0855', 'city': 'Kumamoto', 'country': 'Japan', 'facility': 'Higashi Dental Office', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}], 'overallOfficials': [{'name': 'Christelle Haziza, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Philip Morris Products S.A.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philip Morris Products S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}