Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-03-02 @ 5:51 PM
Study NCT ID:
NCT02649556
Status:
COMPLETED
Last Update Posted:
2020-12-04
First Post:
2016-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A 26-week Extension of the ZRHR-ERS-09-US Study Evaluating Biological and Functional Changes in Healthy Smokers After Switching to THS 2.2
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'christelle.haziza@pmi.com', 'phone': '+41 58 242 11 11', 'title': 'Christelle Haziza', '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': '18 months (from March 2015 to September 2016)', 'description': 'Of the 984 subjects who started the original study (NCT02396381), 20 subjects without a valid safety assessment and 24 subjects from a site terminated for non-GCP compliance were excluded from the safety population (N=940). The safety population comprised the 857 subjects of the Full Analysis Set - As Exposed (FAS-EX), who had at least one record of reported product use post randomization, and 83 subjects who were randomized and had at least 1 valid safety assessment.', 'eventGroups': [{'id': 'EG000', 'title': 'THS 2.2 Use', 'description': 'The "THS 2.2 use" product use category was defined as THS use of 70% or more over the entire analysis period.\n\n(≥1 THS 2.2 or CC, and ≥70% THS 2.2 use over the analysis period, and ≥70% THS 2.2 use on \\>50% of days in the analysis period.)', 'otherNumAtRisk': 241, 'deathsNumAtRisk': 241, 'otherNumAffected': 40, 'seriousNumAtRisk': 241, 'deathsNumAffected': 1, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'CC Use', 'description': 'The "CC use" product use category was defined as THS use of less than 1% over the entire analysis period.\n\n(≥1 THS 2.2 or CC use, and \\<1% THS 2.2 use over the entire analysis period and \\<1% THS 2.2 use on ≥ 50% of days in the analysis period.)', 'otherNumAtRisk': 434, 'deathsNumAtRisk': 434, 'otherNumAffected': 87, 'seriousNumAtRisk': 434, 'deathsNumAffected': 1, 'seriousNumAffected': 15}, {'id': 'EG002', 'title': 'Dual Use', 'description': 'The "Dual use" product use category was defined as THS use of less than 70% over the entire analysis period.\n\n(≥ 1 THS 2.2 or CC and, 1% ≤THS 2.2 \\<70% over the analysis period, or THS 2.2-use and CC use categories do not apply to 50% of these days.)\n\n.', 'otherNumAtRisk': 159, 'deathsNumAtRisk': 159, 'otherNumAffected': 26, 'seriousNumAtRisk': 159, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Other Use', 'description': '"Other use" refers to any other product use over the entire analysis period. (Subjects with missing product use data, subjects using e-cigarettes or other tobacco products, quitters, or subjects who switched across different use patterns.)', 'otherNumAtRisk': 106, 'deathsNumAtRisk': 106, 'otherNumAffected': 13, 'seriousNumAtRisk': 106, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 25, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 434, 'numEvents': 45, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 434, 'numEvents': 40, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 434, 'numEvents': 28, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'seriousEvents': [{'term': 'Appendicitis with Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 434, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 434, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Cellulitis staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 434, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Epiglottitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 434, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 434, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pneumonia mycoplasmal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 434, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 434, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Urosepsis with Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 434, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Head injury with Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 434, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 434, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 434, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Multiple fractures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 434, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Rib fracture, Clavicle fracture, Pulmonary contusion, Pleural effusion, and Traumatic Hemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 434, 'numEvents': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Alchohol abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 434, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 434, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 434, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 434, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Metastases to small intestine with Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 434, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Papillary thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 434, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 434, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Costochondritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 434, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Vertebral osteophyte with Cervical Myelopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 434, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 434, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 434, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pancreatitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 434, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 434, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 434, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Bereavement and Adjustment Disorder with Depressed Mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 434, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 434, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Foot Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 434, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pyelonephritis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 434, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Levels of High Density Lipoprotein C (HDL-C).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'THS 2.2 Use', 'description': 'The "THS 2.2 use" product use category was defined as THS use of 70% or more over the entire analysis period.\n\n(≥1 THS 2.2 or CC, and ≥70% THS 2.2 use over the analysis period, and ≥70% THS 2.2 use on \\>50% of days in the analysis period.)'}, {'id': 'OG001', 'title': 'CC Use', 'description': 'The "CC use" product use category was defined as THS use of less than 1% over the entire analysis period.\n\n(≥1 THS 2.2 or CC use, and \\<1% THS 2.2 use over the entire analysis period and \\<1% THS 2.2 use on ≥ 50% of days in the analysis period.)'}, {'id': 'OG002', 'title': 'Dual Use', 'description': 'The "Dual use" product use category was defined as THS use of less than 70% over the entire analysis period.\n\n(≥ 1 THS 2.2 or CC and, 1% ≤THS 2.2 \\<70% over the analysis period, or THS 2.2-use and CC use categories do not apply to 50% of these days.)'}, {'id': 'OG003', 'title': 'Other Use', 'description': '"Other use" refers to any other product use over the entire analysis period. (Subjects with missing product use data, subjects using e-cigarettes or other tobacco products, quitters, or subjects who switched across different use patterns.)'}], 'classes': [{'categories': [{'measurements': [{'value': '52.2', 'groupId': 'OG000', 'lowerLimit': '49.5', 'upperLimit': '54.8'}, {'value': '50.6', 'groupId': 'OG001', 'lowerLimit': '48.9', 'upperLimit': '52.3'}, {'value': '54.0', 'groupId': 'OG002', 'lowerLimit': '49.7', 'upperLimit': '58.4'}, {'value': '54.7', 'groupId': 'OG003', 'lowerLimit': '49.2', 'upperLimit': '60.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.75', 'ciLowerLimit': '-0.160', 'ciUpperLimit': '3.65', 'groupDescription': 'The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the "smokers\' health profile". This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of LS Mean difference of HDL-C levels between CC and THS 2.2 and related 95% CI.', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Mixed model conducted on original values with visit, baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect.'}], 'paramType': 'MEAN', 'timeFrame': '52 weeks', 'description': 'Concentrations (mg/dL) measured in serum. Mean values are provided as descriptive statistics.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - As Exposed Analysis (FAS-EX). Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).'}, {'type': 'PRIMARY', 'title': 'Levels of White Blood Cells (WBC).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'THS 2.2 Use', 'description': 'The "THS 2.2 use" product use category was defined as THS use of 70% or more over the entire analysis period.\n\n(≥1 THS 2.2 or CC, and ≥70% THS 2.2 use over the analysis period, and ≥70% THS 2.2 use on \\>50% of days in the analysis period.)'}, {'id': 'OG001', 'title': 'CC Use', 'description': 'The "CC use" product use category was defined as THS use of less than 1% over the entire analysis period.\n\n(≥1 THS 2.2 or CC use, and \\<1% THS 2.2 use over the entire analysis period and \\<1% THS 2.2 use on ≥ 50% of days in the analysis period.)'}, {'id': 'OG002', 'title': 'Dual Use', 'description': 'The "Dual use" product use category was defined as THS use of less than 70% over the entire analysis period.\n\n(≥ 1 THS 2.2 or CC and, 1% ≤THS 2.2 \\<70% over the analysis period, or THS 2.2-use and CC use categories do not apply to 50% of these days.)'}, {'id': 'OG003', 'title': 'Other Use', 'description': '"Other use" refers to any other product use over the entire analysis period. (Subjects with missing product use data, subjects using e-cigarettes or other tobacco products, quitters, or subjects who switched across different use patterns.)'}], 'classes': [{'categories': [{'measurements': [{'value': '6.73', 'groupId': 'OG000', 'lowerLimit': '6.47', 'upperLimit': '6.99'}, {'value': '7.31', 'groupId': 'OG001', 'lowerLimit': '7.07', 'upperLimit': '7.54'}, {'value': '7.28', 'groupId': 'OG002', 'lowerLimit': '6.85', 'upperLimit': '7.71'}, {'value': '7.57', 'groupId': 'OG003', 'lowerLimit': '6.85', 'upperLimit': '8.29'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.413', 'ciLowerLimit': '-0.694', 'ciUpperLimit': '-0.131', 'groupDescription': 'The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the "smokers\' health profile". This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of LS Mean difference of White Blood Cell counts between CC and THS 2.2 and related 95% CI.', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Mixed model conducted on original values with visit, baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect.'}], 'paramType': 'MEAN', 'timeFrame': '52 weeks', 'description': 'Total count in blood (GI/L). Mean values are provided as descriptive statistics.', 'unitOfMeasure': 'GI/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - As Exposed Analysis (FAS-EX). Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).'}, {'type': 'PRIMARY', 'title': 'Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'THS 2.2 Use', 'description': 'The "THS 2.2 use" product use category was defined as THS use of 70% or more over the entire analysis period.\n\n(≥1 THS 2.2 or CC, and ≥70% THS 2.2 use over the analysis period, and ≥70% THS 2.2 use on \\>50% of days in the analysis period.)'}, {'id': 'OG001', 'title': 'CC Use', 'description': 'The "CC use" product use category was defined as THS use of less than 1% over the entire analysis period.\n\n(≥1 THS 2.2 or CC use, and \\<1% THS 2.2 use over the entire analysis period and \\<1% THS 2.2 use on ≥ 50% of days in the analysis period.)'}, {'id': 'OG002', 'title': 'Dual Use', 'description': 'The "Dual use" product use category was defined as THS use of less than 70% over the entire analysis period.\n\n(≥ 1 THS 2.2 or CC and, 1% ≤THS 2.2 \\<70% over the analysis period, or THS 2.2-use and CC use categories do not apply to 50% of these days.)'}, {'id': 'OG003', 'title': 'Other Use', 'description': '"Other use" refers to any other product use over the entire analysis period. (Subjects with missing product use data, subjects using e-cigarettes or other tobacco products, quitters, or subjects who switched across different use patterns.)'}], 'classes': [{'categories': [{'measurements': [{'value': '93.2', 'groupId': 'OG000', 'lowerLimit': '91.1', 'upperLimit': '95.2'}, {'value': '92.3', 'groupId': 'OG001', 'lowerLimit': '90.7', 'upperLimit': '94.0'}, {'value': '91.1', 'groupId': 'OG002', 'lowerLimit': '88.2', 'upperLimit': '94.1'}, {'value': '95.2', 'groupId': 'OG003', 'lowerLimit': '90.1', 'upperLimit': '100'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.914', 'ciLowerLimit': '-0.339', 'ciUpperLimit': '2.17', 'groupDescription': 'The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the "smokers\' health profile". This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of LS Mean difference of FEV1 levels between CC and THS 2.2 and related 95% CI.', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Mixed model conducted on original values with visit, baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect.'}], 'paramType': 'MEAN', 'timeFrame': '52 weeks', 'description': 'FEV1 post-bronchodilator and expressed as percentage predicted (FEV1 %pred). Mean values are provided as descriptive statistics.', 'unitOfMeasure': 'Percent of predicted FEV1', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - As Exposed Analysis (FAS-EX). Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).'}, {'type': 'PRIMARY', 'title': 'Concentrations of Soluble Intercellular Adhesion Molecule 1 (sICAM-1).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'THS 2.2 Use', 'description': 'The "THS 2.2 use" product use category was defined as THS use of 70% or more over the entire analysis period.\n\n(≥1 THS 2.2 or CC, and ≥70% THS 2.2 use over the analysis period, and ≥70% THS 2.2 use on \\>50% of days in the analysis period.)'}, {'id': 'OG001', 'title': 'CC Use', 'description': 'The "CC use" product use category was defined as THS use of less than 1% over the entire analysis period.\n\n(≥1 THS 2.2 or CC use, and \\<1% THS 2.2 use over the entire analysis period and \\<1% THS 2.2 use on ≥ 50% of days in the analysis period.)'}, {'id': 'OG002', 'title': 'Dual Use', 'description': 'The "Dual use" product use category was defined as THS use of less than 70% over the entire analysis period.\n\n(≥ 1 THS 2.2 or CC and, 1% ≤THS 2.2 \\<70% over the analysis period, or THS 2.2-use and CC use categories do not apply to 50% of these days.)'}, {'id': 'OG003', 'title': 'Other Use', 'description': '"Other use" refers to any other product use over the entire analysis period. (Subjects with missing product use data, subjects using e-cigarettes or other tobacco products, quitters, or subjects who switched across different use patterns.)'}], 'classes': [{'categories': [{'measurements': [{'value': '246', 'groupId': 'OG000', 'lowerLimit': '230', 'upperLimit': '263'}, {'value': '258', 'groupId': 'OG001', 'lowerLimit': '244', 'upperLimit': '272'}, {'value': '269', 'groupId': 'OG002', 'lowerLimit': '252', 'upperLimit': '286'}, {'value': '255', 'groupId': 'OG003', 'lowerLimit': '222', 'upperLimit': '292'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': '% Relative Reduction', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.11', 'ciLowerLimit': '0.0231', 'ciUpperLimit': '6.10', 'estimateComment': 'Derived as 100 x (1 - Geometric LS Mean Ratio)', 'groupDescription': 'The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the "smokers\' health profile". This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of relative reduction of sICAM-1 levels between CC and THS 2.2 and related 95% CI.', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Mixed model conducted on log-transformed values with visit, log-transformed baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '52 weeks', 'description': 'Concentrations (ng/mL) measured in serum. Geometric Mean values are provided as descriptive statistics.', 'unitOfMeasure': 'ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - As Exposed Analysis (FAS-EX). Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).'}, {'type': 'PRIMARY', 'title': 'Concentrations of 11-dehydrothromboxane B2 (11-DTXB2).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'THS 2.2 Use', 'description': 'The "THS 2.2 use" product use category was defined as THS use of 70% or more over the entire analysis period.\n\n(≥1 THS 2.2 or CC, and ≥70% THS 2.2 use over the analysis period, and ≥70% THS 2.2 use on \\>50% of days in the analysis period.)'}, {'id': 'OG001', 'title': 'CC Use', 'description': 'The "CC use" product use category was defined as THS use of less than 1% over the entire analysis period.\n\n(≥1 THS 2.2 or CC use, and \\<1% THS 2.2 use over the entire analysis period and \\<1% THS 2.2 use on ≥ 50% of days in the analysis period.)'}, {'id': 'OG002', 'title': 'Dual Use', 'description': 'The "Dual use" product use category was defined as THS use of less than 70% over the entire analysis period.\n\n(≥ 1 THS 2.2 or CC and, 1% ≤THS 2.2 \\<70% over the analysis period, or THS 2.2-use and CC use categories do not apply to 50% of these days.)'}, {'id': 'OG003', 'title': 'Other Use', 'description': '"Other use" refers to any other product use over the entire analysis period. (Subjects with missing product use data, subjects using e-cigarettes or other tobacco products, quitters, or subjects who switched across different use patterns.)'}], 'classes': [{'categories': [{'measurements': [{'value': '582', 'groupId': 'OG000', 'lowerLimit': '518', 'upperLimit': '654'}, {'value': '586', 'groupId': 'OG001', 'lowerLimit': '538', 'upperLimit': '638'}, {'value': '595', 'groupId': 'OG002', 'lowerLimit': '510', 'upperLimit': '693'}, {'value': '536', 'groupId': 'OG003', 'lowerLimit': '396', 'upperLimit': '727'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': '% Relative Reduction', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.44', 'ciLowerLimit': '-8.74', 'ciUpperLimit': '14.3', 'estimateComment': 'Derived as 100 x (1-Geometric LS Mean Ratio)', 'groupDescription': 'The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the "smokers\' health profile". This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of relative reduction of 11-DTXB2 levels between CC and THS 2.2 and related 95% CI.', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Mixed model conducted on log-transformed values with visit, log-transformed baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '52 weeks', 'description': 'Concentrations measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat). Geometric Mean values are provided as descriptive statistics.', 'unitOfMeasure': 'pg/mg creat', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - As Exposed Analysis (FAS-EX). Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).'}, {'type': 'PRIMARY', 'title': 'Concentrations of 8-epi-prostaglandin F2α (8-epi-PGF2α).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'THS 2.2 Use', 'description': 'The "THS 2.2 use" product use category was defined as THS use of 70% or more over the entire analysis period.\n\n(≥1 THS 2.2 or CC, and ≥70% THS 2.2 use over the analysis period, and ≥70% THS 2.2 use on \\>50% of days in the analysis period.)'}, {'id': 'OG001', 'title': 'CC Use', 'description': 'The "CC use" product use category was defined as THS use of less than 1% over the entire analysis period.\n\n(≥1 THS 2.2 or CC use, and \\<1% THS 2.2 use over the entire analysis period and \\<1% THS 2.2 use on ≥ 50% of days in the analysis period.)'}, {'id': 'OG002', 'title': 'Dual Use', 'description': 'The "Dual use" product use category was defined as THS use of less than 70% over the entire analysis period.\n\n(≥ 1 THS 2.2 or CC and, 1% ≤THS 2.2 \\<70% over the analysis period, or THS 2.2-use and CC use categories do not apply to 50% of these days.)'}, {'id': 'OG003', 'title': 'Other Use', 'description': '"Other use" refers to any other product use over the entire analysis period. (Subjects with missing product use data, subjects using e-cigarettes or other tobacco products, quitters, or subjects who switched across different use patterns.)'}], 'classes': [{'categories': [{'measurements': [{'value': '307', 'groupId': 'OG000', 'lowerLimit': '279', 'upperLimit': '338'}, {'value': '327', 'groupId': 'OG001', 'lowerLimit': '307', 'upperLimit': '348'}, {'value': '326', 'groupId': 'OG002', 'lowerLimit': '293', 'upperLimit': '362'}, {'value': '364', 'groupId': 'OG003', 'lowerLimit': '289', 'upperLimit': '458'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': '% Relative Reduction', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.15', 'ciLowerLimit': '-1.03', 'ciUpperLimit': '14.7', 'estimateComment': 'Derived as 100 x (1 - Geometric LS Mean Ratio)', 'groupDescription': 'The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the "smokers\' health profile". This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of relative reduction of 8-epi-PGF2α levels between CC and THS 2.2 and related 95% CI.', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Mixed model conducted on log-transformed values with visit, log-transformed baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '52 weeks', 'description': 'Concentrations measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat). Geometric Mean values are provided as descriptive statistics.', 'unitOfMeasure': 'pg/mg creat', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - As Exposed Analysis (FAS-EX). Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).'}, {'type': 'PRIMARY', 'title': 'Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'THS 2.2 Use', 'description': 'The "THS 2.2 use" product use category was defined as THS use of 70% or more over the entire analysis period.\n\n(≥1 THS 2.2 or CC, and ≥70% THS 2.2 use over the analysis period, and ≥70% THS 2.2 use on \\>50% of days in the analysis period.)'}, {'id': 'OG001', 'title': 'CC Use', 'description': 'The "CC use" product use category was defined as THS use of less than 1% over the entire analysis period.\n\n(≥1 THS 2.2 or CC use, and \\<1% THS 2.2 use over the entire analysis period and \\<1% THS 2.2 use on ≥ 50% of days in the analysis period.)'}, {'id': 'OG002', 'title': 'Dual Use', 'description': 'The "Dual use" product use category was defined as THS use of less than 70% over the entire analysis period.\n\n(≥ 1 THS 2.2 or CC and, 1% ≤THS 2.2 \\<70% over the analysis period, or THS 2.2-use and CC use categories do not apply to 50% of these days.)'}, {'id': 'OG003', 'title': 'Other Use', 'description': '"Other use" refers to any other product use over the entire analysis period. (Subjects with missing product use data, subjects using e-cigarettes or other tobacco products, quitters, or subjects who switched across different use patterns.)'}], 'classes': [{'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000', 'lowerLimit': '105', 'upperLimit': '168'}, {'value': '269', 'groupId': 'OG001', 'lowerLimit': '238', 'upperLimit': '305'}, {'value': '253', 'groupId': 'OG002', 'lowerLimit': '207', 'upperLimit': '309'}, {'value': '304', 'groupId': 'OG003', 'lowerLimit': '214', 'upperLimit': '431'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': '% Relative Reduction', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '46.3', 'ciLowerLimit': '36.2', 'ciUpperLimit': '54.8', 'estimateComment': 'Derived as 100 x (1 - Geometric LS Mean Ratio)', 'groupDescription': 'The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the "smokers\' health profile". This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of relative reduction of Total NNAL levels between CC and THS 2.2 and related 95% CI.', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Mixed model conducted on log-transformed values with visit, log-transformed baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '52 weeks', 'description': 'Concentrations measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat). Geometric Mean values are provided as descriptive statistics.', 'unitOfMeasure': 'pg/mg creat', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - As Exposed Analysis (FAS-EX). Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).'}, {'type': 'PRIMARY', 'title': 'Levels of Carboxyhemoglobin (COHb).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'THS 2.2 Use', 'description': 'The "THS 2.2 use" product use category was defined as THS use of 70% or more over the entire analysis period.\n\n(≥1 THS 2.2 or CC, and ≥70% THS 2.2 use over the analysis period, and ≥70% THS 2.2 use on \\>50% of days in the analysis period.)'}, {'id': 'OG001', 'title': 'CC Use', 'description': 'The "CC use" product use category was defined as THS use of less than 1% over the entire analysis period.\n\n(≥1 THS 2.2 or CC use, and \\<1% THS 2.2 use over the entire analysis period and \\<1% THS 2.2 use on ≥ 50% of days in the analysis period.)'}, {'id': 'OG002', 'title': 'Dual Use', 'description': 'The "Dual use" product use category was defined as THS use of less than 70% over the entire analysis period.\n\n(≥ 1 THS 2.2 or CC and, 1% ≤THS 2.2 \\<70% over the analysis period, or THS 2.2-use and CC use categories do not apply to 50% of these days.)'}, {'id': 'OG003', 'title': 'Other Use', 'description': '"Other use" refers to any other product use over the entire analysis period. (Subjects with missing product use data, subjects using e-cigarettes or other tobacco products, quitters, or subjects who switched across different use patterns.)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.59', 'groupId': 'OG000', 'lowerLimit': '2.24', 'upperLimit': '3.01'}, {'value': '4.06', 'groupId': 'OG001', 'lowerLimit': '3.77', 'upperLimit': '4.38'}, {'value': '3.92', 'groupId': 'OG002', 'lowerLimit': '3.44', 'upperLimit': '4.46'}, {'value': '5.22', 'groupId': 'OG003', 'lowerLimit': '4.47', 'upperLimit': '6.11'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': '% Relative Reduction', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '31.7', 'ciLowerLimit': '23.3', 'ciUpperLimit': '39.1', 'estimateComment': 'Derived as 100 x (1 - Geometric LS Mean Ratio)', 'groupDescription': 'The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the "smokers\' health profile". This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of relative reduction of COHb levels between CC and THS 2.2 and related 95% CI.', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Mixed model conducted on log-transformed values with visit, log-transformed baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '52 weeks', 'description': 'Carboxyhemoglobin (COHb) is assayed from whole blood. Expressed as % of saturation of hemoglobin. Geometric Mean values are provided as descriptive statistics.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - As Exposed Analysis (FAS-EX). Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'THS 2.2 Use', 'description': 'This reporting group comprised 230 subjects. The "THS 2.2 use" product use category was defined as THS use of 70% or more over the entire analysis period. (≥1 THS 2.2 or CC, and ≥70% THS 2.2 use over the analysis period, and ≥70% THS 2.2 use on \\>50% of days in the analysis period.)'}, {'id': 'FG001', 'title': 'CC Use', 'description': 'This reporting group comprised 424 subjects. The "CC use" product use category was defined as THS use of less than 1% over the entire analysis period. (≥1 THS 2.2 or CC use, and \\<1% THS 2.2 use over the entire analysis period and \\<1% THS 2.2 use on ≥ 50% of days in the analysis period.)'}, {'id': 'FG002', 'title': 'Dual Use', 'description': 'This reporting group comprised 152 subjects. The "Dual use" product use category was defined as THS use of less than 70% over the entire analysis period. (≥ 1 THS 2.2 or CC and, 1% ≤THS 2.2 \\<70% over the analysis period, or THS 2.2-use and CC use categories do not apply to 50% of these days.)'}, {'id': 'FG003', 'title': 'Other Use', 'description': 'This reporting group comprised 51 subjects. "Other use" refers to any other product use over the entire analysis period. (Subjects with missing product use data, subjects using e-cigarettes or other tobacco products, quitters, or subjects who switched across different use patterns.)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '230'}, {'groupId': 'FG001', 'numSubjects': '424'}, {'groupId': 'FG002', 'numSubjects': '152'}, {'groupId': 'FG003', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '167'}, {'groupId': 'FG001', 'numSubjects': '312'}, {'groupId': 'FG002', 'numSubjects': '102'}, {'groupId': 'FG003', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '112'}, {'groupId': 'FG002', 'numSubjects': '50'}, {'groupId': 'FG003', 'numSubjects': '23'}]}]}], 'recruitmentDetails': 'Of the 984 subjects (488 in the THS arm and 496 in the CC arm) who were enrolled and randomized into the original study, NCT02396381, 672 subjects were enrolled into the extension study (309 in the THS arm and 363 in the CC arm).', 'preAssignmentDetails': '672 subjects enrolled in the extension study; the 857 subjects in the Full Analysis Set - As Exposed (FAS-EX) included subjects for combined analyses from the original six month study who did not enter the extension study. The analysis was performed according to subjects\' exposure over the 12 month period as detailed in "Arm/Group" (Reporting Groups) table.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'BG000'}, {'value': '424', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '857', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'THS 2.2 Use', 'description': 'The "THS 2.2 use" product use category was defined as THS use of 70% or more over the entire analysis period.\n\n(≥1 THS 2.2 or CC, and ≥70% THS 2.2 use over the analysis period, and ≥70% THS 2.2 use on \\>50% of days in the analysis period.)'}, {'id': 'BG001', 'title': 'CC Use', 'description': 'The "CC use" product use category was defined as THS use of less than 1% over the entire analysis period.\n\n(≥1 THS 2.2 or CC use, and \\<1% THS 2.2 use over the entire analysis period and \\<1% THS 2.2 use on ≥ 50% of days in the analysis period.)'}, {'id': 'BG002', 'title': 'Dual Use', 'description': 'The "Dual use" product use category was defined as THS use of less than 70% over the entire analysis period.\n\n(≥ 1 THS 2.2 or CC and, 1% ≤THS 2.2 \\<70% over the analysis period, or THS 2.2-use and CC use categories do not apply to 50% of these days.)'}, {'id': 'BG003', 'title': 'Other Use', 'description': '"Other use" refers to any other product use over the entire analysis period. (Subjects with missing product use data, subjects using e-cigarettes or other tobacco products, quitters, or subjects who switched across different use patterns.)'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.8', 'spread': '9.68', 'groupId': 'BG000'}, {'value': '45.2', 'spread': '9.54', 'groupId': 'BG001'}, {'value': '44.2', 'spread': '9.76', 'groupId': 'BG002'}, {'value': '44.5', 'spread': '8.21', 'groupId': 'BG003'}, {'value': '44.6', 'spread': '9.55', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '180', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '353', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '244', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '504', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '213', 'groupId': 'BG000'}, {'value': '396', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '804', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '151', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '182', 'groupId': 'BG000'}, {'value': '338', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '679', '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': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '27.0', 'spread': '4.06', 'groupId': 'BG000'}, {'value': '27.1', 'spread': '4.13', 'groupId': 'BG001'}, {'value': '26.9', 'spread': '4.25', 'groupId': 'BG002'}, {'value': '26.6', 'spread': '4.91', 'groupId': 'BG003'}, {'value': '27.0', 'spread': '4.18', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-08-23', 'size': 2470509, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-05-15T04:19', 'hasProtocol': True}, {'date': '2017-12-08', 'size': 2633898, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-05-15T04:24', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 672}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2017-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-10', 'studyFirstSubmitDate': '2016-01-05', 'resultsFirstSubmitDate': '2020-05-25', 'studyFirstSubmitQcDate': '2016-01-06', 'lastUpdatePostDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-10', 'studyFirstPostDateStruct': {'date': '2016-01-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Levels of High Density Lipoprotein C (HDL-C).', 'timeFrame': '52 weeks', 'description': 'Concentrations (mg/dL) measured in serum. Mean values are provided as descriptive statistics.'}, {'measure': 'Levels of White Blood Cells (WBC).', 'timeFrame': '52 weeks', 'description': 'Total count in blood (GI/L). Mean values are provided as descriptive statistics.'}, {'measure': 'Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1).', 'timeFrame': '52 weeks', 'description': 'FEV1 post-bronchodilator and expressed as percentage predicted (FEV1 %pred). Mean values are provided as descriptive statistics.'}, {'measure': 'Concentrations of Soluble Intercellular Adhesion Molecule 1 (sICAM-1).', 'timeFrame': '52 weeks', 'description': 'Concentrations (ng/mL) measured in serum. Geometric Mean values are provided as descriptive statistics.'}, {'measure': 'Concentrations of 11-dehydrothromboxane B2 (11-DTXB2).', 'timeFrame': '52 weeks', 'description': 'Concentrations measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat). Geometric Mean values are provided as descriptive statistics.'}, {'measure': 'Concentrations of 8-epi-prostaglandin F2α (8-epi-PGF2α).', 'timeFrame': '52 weeks', 'description': 'Concentrations measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat). Geometric Mean values are provided as descriptive statistics.'}, {'measure': 'Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL).', 'timeFrame': '52 weeks', 'description': 'Concentrations measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat). Geometric Mean values are provided as descriptive statistics.'}, {'measure': 'Levels of Carboxyhemoglobin (COHb).', 'timeFrame': '52 weeks', 'description': 'Carboxyhemoglobin (COHb) is assayed from whole blood. Expressed as % of saturation of hemoglobin. Geometric Mean values are provided as descriptive statistics.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Modified risk tobacco product', 'Conventional cigarette', 'Exposure response', 'Smoking', 'Tobacco Heating System'], 'conditions': ['Smoking']}, 'referencesModule': {'references': [{'pmid': '38804903', 'type': 'DERIVED', 'citation': 'Ansari SM, Hession PS, David M, Blanc N, de La Bourdonnaye G, Pouly S, Haziza C. Impact of switching from cigarette smoking to tobacco heating system use on biomarkers of potential harm in a randomized trial. Biomarkers. 2024 Jul;29(5):298-314. doi: 10.1080/1354750X.2024.2358318. Epub 2024 Jun 7.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the ZRHR-ERS-09-EXT-US study is to further assess the effect of the Tobacco Heating System 2.2 (THS 2.2), a candidate Modified Risk Tobacco Product, compared to conventional cigarettes (CC) on the components of the "smokers\' health profile" for a prolonged period of 26 weeks, providing additional information to the results of the original study ZRHR-ERS-09-US of 26-week exposure (NCT02396381). In total, the ZRHR-ERS-09-EXT-US study will extend the exposure period to 52 weeks.', 'detailedDescription': 'The ZRHR-ERS-09-EXT-US study is a 26-week extension of the original study ZRHR-ERS-09-US.\n\nThe subjects in the Full Analysis Set - As Exposed (FAS-EX) included subjects for combined analyses from the original six month study (ZRHR-ERS-09-US ) who did not enter the extension study (ZRHR-ERS-09-EXT-US).\n\nThis study was conducted as a separate investigation, as a follow-up of the randomized exposure period of the original study, extending the exposure from Week 26 (Visit 10 \\[V10\\]) to Week 52 (Visit 16 \\[V16\\]), and using the same sites.\n\nSubjects continued to use the product they were randomized to in the original study ZRHR-ERS-09-US (THS 2.2 arm or CC arm).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject completed V10 of the original study (ZRHR-ERS-09-US).\n* The subject is willing to comply to study procedures and to continue to use the product he/she was allocated to during the original study (THS 2.2 or CC) for an additional 26 weeks at V10.\n* Subject has given written informed consent to enter the 26-week extension study at V10.\n\nExclusion Criteria:\n\n* Clinically relevant medical conditions that in the opinion of the investigators would jeopardize the safety of the participant.\n* As per judgment of the PI(s) or designee(s), the subject cannot participate in the study for any reason (e.g. medical, psychiatric and/or social reason).\n* Subject has made an attempt to quit using tobacco-containing products (e.g. CC and THS 2.2) during the original study.\n* Female subject is pregnant or breast feeding.\n* Female subject who does not agree to use an acceptable method of effective contraception.'}, 'identificationModule': {'nctId': 'NCT02649556', 'briefTitle': 'A 26-week Extension of the ZRHR-ERS-09-US Study Evaluating Biological and Functional Changes in Healthy Smokers After Switching to THS 2.2', 'organization': {'class': 'INDUSTRY', 'fullName': 'Philip Morris Products S.A.'}, 'officialTitle': 'A 26-week Extension Study to Determine the Biological and Functional Changes in Healthy Smokers Who Switched From Conventional Cigarettes (CC) to Tobacco Heating System 2.2 (THS 2.2) Compared to Those Who Continued to Smoke CC in the ZRHR-ERS-09-US Study', 'orgStudyIdInfo': {'id': 'ZRHR-ERS-09-EXT-US'}, 'secondaryIdInfos': [{'id': 'ZRHR-ERS-09-EXT-US', 'type': 'OTHER', 'domain': 'Philip Morris Products S.A.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'THS 2.2', 'description': 'Ad libitum use of THS 2.2', 'interventionNames': ['Other: THS 2.2']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CC', 'description': 'Ad libitum use of CC', 'interventionNames': ['Other: CC']}], 'interventions': [{'name': 'THS 2.2', 'type': 'OTHER', 'description': 'Ad libitum use of THS 2.2 in an ambulatory setting for 26 weeks.', 'armGroupLabels': ['THS 2.2']}, {'name': 'CC', 'type': 'OTHER', 'description': "Ad libitum use of CC in an ambulatory setting for 26 weeks.\n\nThe subject's own preferred brands of CC (no brand restriction) continue to be used as the reference product.", 'armGroupLabels': ['CC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85283', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Celerion Arizona', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '33765', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research West Florida', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '32117', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Covance, Inc', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Compass Research', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33603', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research West Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '32162', 'city': 'The Villages', 'state': 'Florida', 'country': 'United States', 'facility': 'Compass Research', 'geoPoint': {'lat': 28.93408, 'lon': -81.95994}}, {'zip': '40509', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Central Kentucky Research Associate', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '68502', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Celerion Lincoln', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '27518', 'city': 'Cary', 'state': 'North Carolina', 'country': 'United States', 'facility': 'PMG Research of Cary', 'geoPoint': {'lat': 35.79154, 'lon': -78.78112}}, {'zip': '28209', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'PMG Research of Charlotte', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27609', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'PMG Research of Raleigh', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'PMG Research of Wilmington', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '45417', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Midwest Clinical Research', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '37620', 'city': 'Bristol', 'state': 'Tennessee', 'country': 'United States', 'facility': 'PMG Research of Bristol', 'geoPoint': {'lat': 36.59511, 'lon': -82.18874}}, {'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'NOCCR', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Benchmark', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '76135', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Benchmark', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '76904', 'city': 'San Angelo', 'state': 'Texas', 'country': 'United States', 'facility': 'Benchmark', 'geoPoint': {'lat': 31.46377, 'lon': -100.43704}}, {'zip': '23294', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'National Clinical Research', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Christelle Haziza, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Philip Morris Products S.A.'}, {'name': 'Danielle Armas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Celerion Arizona'}, {'name': 'Leonard Dunn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Research West Florida'}, {'name': 'Hugh Coleman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Covance'}, {'name': 'George Stoica, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Compass Research'}, {'name': 'Mark Adams, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Central Kentucky Research Associate'}, {'name': 'Peter Davidson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Celerion Lincoln'}, {'name': 'John Rubino, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PMG Research of Raleigh'}, {'name': 'George Raad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PMG Research of Charlotte'}, {'name': 'Kevin Cannon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PMG Research of Wilmington'}, {'name': 'Derek Schroder, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PMG Research of Cary'}, {'name': 'Stephanie Powell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PMG Research of Bristol'}, {'name': 'William Smith, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NOCCR'}, {'name': 'Darrell Herrington, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Benchmark'}, {'name': 'Laurence Chu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Benchmark'}, {'name': 'William Seger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Benchmark'}, {'name': 'David Subich, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Compass Research'}, {'name': 'Lon Lynn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Research West Florida'}, {'name': 'Isabel Kuhare-Arcure, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Midwest Clinical Research'}, {'name': 'Keith Scott, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Clinical Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philip Morris Products S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}