Tobacco Use
Conditions
Brief summary
The purpose of this study is to evaluate changes in exposure to selected harmful and potentially harmful constituents (HPHC) by measuring biomarkers in adult smokers who partially or completely switch from smoking cigarettes to oral tobacco-derived nicotine (OTDN) products compared to those who continue exclusive smoking cigarettes or stop using all tobacco products.
Detailed description
This is an open label, randomized, 6 parallel-group clinical study evaluating changes in exposure to selected HPHCs, subjective effects, and product use behavior in adult smokers relative to continued smoking who are randomly assigned to continue smoking, partially or completely switch to oral tobacco-derived nicotine products, or stop using any tobacco products for 7 days.
Interventions
OTHEROTDN product 1
Oral tobacco-derived nicotine product
OTHEROTDN product 2
Oral tobacco-derived nicotine product
OTHERTobacco Cessation
Tobacco Cessation
Sponsors
Altria Client Services LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Voluntary consent to participate in this study documented on the signed informed consent form (ICF). 2. Healthy adult males and females 21 to 65 years of age, inclusive, at Screening 3. Smoking history of an average of at least 10 but no more than 30 factory manufactured combustible cigarettes daily for at least 1 year prior to Screening. Brief periods (i.e., up to 7 consecutive days) of non-smoking during the 3 months prior to Screening (e.g., due to illness or participation in a study where smoking was prohibited) will be permitted. 4. Positive urine cotinine (≥ 500 ng/mL) at Screening. 5. Willing to comply with the requirements of the study. 6. Willing to use all test products after product trial at Check in. 7. Willing and able to abstain from cigarettes from Day 1 through the End of the study.
Exclusion criteria
1. Use of any type of tobacco or nicotine containing products other than manufactured cigarettes (e.g., e vapor products, roll-your-own cigarettes, bidis, snuff, nicotine inhaler, pipe, cigar, chewing tobacco, nicotine patch, nicotine spray, nicotine lozenge, or nicotine gum) in the 7 days prior to Check in 2. Self-reported puffers (i.e., adult smokers who draw smoke from the cigarette into the mouth and throat but do not inhale). 3. Planning to quit smoking in the next 30 days (from Screening visit). 4. History or presence of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, urologic, existing respiratory diseases, immunologic, psychiatric, lymphatic, or cardiovascular disease, or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results. 5. Clinically significant abnormal findings on the vital signs, physical examination, medical history, ECG, or clinical laboratory results, in the opinion of the Investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Baseline (Day -1), Day 5 and Day 7 | Summary of urine total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) amount excreted (ng/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the lower limit of quantitation (LLOQ) (2.00 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value |
| Summary of Urine Total NNAL Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 and Day 7 | Summary of urine total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (2.00 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population) | Baseline (Day -1), Day 5 and Day 7 | Summary of nicotine equivalents amount excreted (mg/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) for each metabolite were set to one-half of the LLOQ for the calculation of nicotine equivalents. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Nicotine equivalents (mg/g creatinine) = nicotine equivalents (μg/mL) x 100 / creatinine (mg/dL) Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value |
| Summary of Nicotine Equivalents Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 and Day 7 | Summary of nicotine equivalents amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) for each metabolite were set to one-half of the LLOQ for the calculation of nicotine equivalents. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Nicotine equivalents (mg/g creatinine) = nicotine equivalents (μg/mL) x 100 / creatinine (mg/dL) % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % |
| Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Baseline (Day -1), Day 5 and Day 7 | Summary of 2-aminonaphthalene (2-AN) amount excreted (ng/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (1.7 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value |
| Summary of 2-AN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 and Day 7 | Summary of 2-aminonaphthalene (2-AN) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (1.7 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % |
| Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Baseline (Day -1), Day 5 and Day 7 | Summary of 4-aminobiphenyl (4-ABP) amount excreted (ng/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (1.5 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value |
| Summary of 4-ABP Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 and Day 7 | Summary of 4-aminobiphenyl (4-ABP) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (1.5 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % |
| Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Baseline (Day -1), Day 5 and Day 7 | Summary of 2-hydroxyethyl mercapturic acid (HEMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.2 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value |
| Summary of HEMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 and Day 7 | Summary of 2-hydroxyethyl mercapturic acid (HEMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.2 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % |
| Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Baseline (Day -1), Day 5 and Day 7 | Summary of 2-cyanoethylmercapturic acid (CEMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.25 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value |
| Summary of CEMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 and Day 7 | Summary of 2-cyanoethylmercapturic acid (CEMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.25 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % |
| Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Baseline (Day -1), Day 5 and Day 7 | Summary of S-phenyl mercapturic acid (S-PMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.02 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value |
| Summary of S-PMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 and Day 7 | Summary of S-phenyl mercapturic acid (S-PMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.02 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % |
| Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Baseline (Day -1), Day 5 and Day 7 | Summary of 3-hydroxy-1-methylpropylmercapturic acid (3-HMPMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (5 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value |
| Summary of 3-HMPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 and Day 7 | Summary of 3-hydroxy-1-methylpropylmercapturic acid (3-HMPMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (5 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % |
| Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Baseline (Day -1), Day 5 and Day 7 | Summary of 3-hydroxypropylmercapturic acid (3-HPMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (25 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value |
| Summary of 3-HPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 and Day 7 | Summary of 3-hydroxypropylmercapturic acid (3-HPMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (25 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % |
| Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Baseline (Day -1), Day 5 and Day 7 | Summary of 2-hydroxypropyl-mercapturic acid (2-HPMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (2.5 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value |
| Summary of 2-HPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 and Day 7 | Summary of 2-hydroxypropyl-mercapturic acid (2-HPMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (2.5 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % |
| Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Baseline (Day -1), Day 5 and Day 7 | Summary of N-acetyl-S-(2-carbamoylethyl)-l-cysteine (AAMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (10 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value |
| Summary of AAMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 and Day 7 | Summary of N-acetyl-S-(2-carbamoylethyl)-l-cysteine (AAMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (10 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % |
| Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Baseline (Day -1), Day 5 and Day 7 | Summary of N-acetyl-S-(2-carbamoyl-2-hydroxyethyl)-l-cysteine (GAMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (1 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value |
| Summary of GAMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 and Day 7 | Summary of N-acetyl-S-(2-carbamoyl-2-hydroxyethyl)-l-cysteine (GAMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (1 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % |
| Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Baseline (Day -1), Day 5 and Day 7 | Summary of 2-hydroxybutenyl-mercapturic acid (2-MHBMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.129 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value |
| Summary of 2-MHBMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 and Day 7 | Summary of 2-hydroxybutenyl-mercapturic acid (2-MHBMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.129 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % |
| Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Baseline (Day -1), Day 5 and Day 7 | Summary of 2-OH-Fluorene (2-OHFLe) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.1 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value |
| Summary of 2-OHFLe Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 and Day 7 | Summary of 2-OH-Fluorene (2-OHFLe) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.1 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % |
| Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Baseline (Day -1), Day 5 and Day 7 | Summary of 2-Naphthol amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.10 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value |
| Summary of 2-Naphthol Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 and Day 7 | Summary of 2-Naphthol amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.10 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % |
| Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Baseline (Day -1), Day 5 and Day 7 | Summary of 1-OH-Phenanthrene (1-OHPhe) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.005 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value |
| Summary of 1-OHPhe Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 and Day 7 | Summary of 1-OH-Phenanthrene (1-OHPhe) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.005 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % |
| Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Baseline (Day -1), Day 5 and Day 7 | Summary of 1-hydroxypyrene (1-OHP) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.01 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value |
| Summary of 1-OHP Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 and Day 7 | Summary of 1-hydroxypyrene (1-OHP) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.01 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % |
| Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population) | Baseline (Day -1), Day 5 and Day 7 | Summary of urine mutagenicity (revertants/24 hours) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Baseline = Day -1. 250 mL urine sample will be concentrated to 1 mL and used for urine mutagenicity testing. The measurement results will be reported as revertants/μL. The urine mutagenicity count in the 24 hour urine will be calculated as: Urine mutagenicity (revertants/24 hour) = Urine mutagenicity (revertants/250 mL) x urine volume/ urine sample volume in mL Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value |
| Summary of Urine Mutagenicity Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 and Day 7 | Summary of urine mutagenicity percent change from Baseline (%) by study group and study day is presented. Baseline = Day -1. 250 mL urine sample will be concentrated to 1 mL and used for urine mutagenicity testing. The measurement results will be reported as revertants/μL. The urine mutagenicity count in the 24 hour urine will be calculated as: Urine mutagenicity (revertants/24 hour) = Urine mutagenicity (revertants/250 mL) x urine volume/ urine sample volume in mL % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % |
| Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population) | Baseline (Day -1), Day 5 and Day 7 | Summary of whole blood carboxyhemoglobin \[COHb\] (% saturation) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Baseline = Day -1. The blood sample for COHb was collected approximately 21:30 on Days -1, 5, and 7 after subjects abstained from product use, as appropriate, for at least 15 minutes prior to blood draw for COHb. Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value |
| Summary of Whole Blood COHb Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 and Day 7 | Summary of whole blood carboxyhemoglobin (COHb) percent change from Baseline (%) is presented. Subjects with valid sample results are included. Baseline = Day -1. The blood sample for COHb was collected approximately 21:30 on Days -1, 5, and 7 after subjects abstained from product use, as appropriate, for at least 15 minutes prior to blood draw for COHb. % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % |
| Cigarette Consumption by Study Group and Study Day (mITT Population) | Day -1 and Day -2 (Baseline), Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 | Summary of cigarette consumption, as number of cigarettes smoked per day (CPD), by study group and study day is presented. Baseline = Average of Days -2 and -1. |
| Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 | Summary of VERVE® Product Used Per Day by Study Group and Study Day is presented. Only study groups that received the test product (VERVE® Discs or VERVE® Chews) are shown. Results are stratified by product flavor (Green Mint, Blue Mint and overall). |
| Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Baseline (Day -1), Day 5 and Day 7 | Summary of N-nitrosonornicotine (NNN) amount excreted (ng/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.500 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value |
| Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 | Summary of total duration (minutes) of VERVE® product per day by Study Group and Study Day. Only study groups that received the test product (VERVE® Discs or VERVE® Chews) are shown. Results are stratified by product flavor (Green Mint, Blue Mint and overall). |
| Summary of Response for Willingness to Use Cigarettes Again Bipolar VAS Scores for Cigarettes by Category, Study Group and Study Product (mITT Population) | Data collected on Day 7 at 21:30 (±30 minutes) during the product use period | Summary of subject responses to Use the Product (Cigarette) Again Bipolar Visual Analogue Scale (VAS) Scores for cigarettes is presented. The Use the Product Again Bipolar VAS is a 100 mm scale ranging from 0 mm (Definitely Would Not) to 100 mm (Definitely Would). The bipolar score is calculated by subtracting 50 from the original VAS score, then categorizing into three categories: -50 to \<0, 0, and \>0 to 50. Higher scores are associated with greater willingness to use the cigarettes again. Mean and standard deviation of the bipolar VAS score per category is shown. The Use the Product Again VAS Score was given to subjects on Day 7 at 21:30 (±30 minutes) during the product use period. The data shown are the means calculated from only those participants with scores in the corresponding category ('-50 to \<0', '0' and '\>0 to 50'). |
| Summary of Response for Willingness to Use the VERVE® Product Again Bipolar VAS Scores for Cigarettes by Category, Study Group and Study Product (mITT Population) | Data collected on Day 7 at 21:30 (±30 minutes) during the product use period | Summary of subject responses to Use the Product (VERVE®) Again Bipolar Visual Analogue Scale (VAS) Scores for the VERVE® test products are presented. The Use the Product Again Bipolar VAS is a 100 mm scale ranging from 0 mm (Definitely Would Not) to 100 mm (Definitely Would). The bipolar score is calculated by subtracting 50 from the original VAS score, then categorizing into three categories: -50 to \<0, 0, and \>0 to 50. Higher scores are associated with greater willingness to use the VERVE® product again. Mean and standard deviation of the bipolar VAS score per category is shown. The Use the Product Again VAS Score was given to subjects on Day 7 at 21:30 (±30 minutes) during the product use period. The data shown are the means calculated from only those participants with scores in the corresponding category ('-50 to \<0', '0' and '\>0 to 50'). |
| Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 | Summary of average VERVE® product use duration (minutes) by Study Group and Study Day is presented. Only study groups that received the test product (VERVE® Discs or VERVE® Chews) are shown. Results are stratified by product flavor (Green Mint, Blue Mint and overall). |
| Summary of NNN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 and Day 7 | Summary of N-nitrosonornicotine (NNN) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.500 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 % |
Countries
United States
Participant flow
Pre-assignment details
Subjects were required to complete a test product tolerability trial and baseline assessment over the course of 3 days prior to randomization on Day 1 of the study. A total of 213 subjects were randomized to one of the six groups in this study.
Participants by arm
| Arm | Count |
|---|---|
| Product Trial All subjects who used a study product during the product trial period, including subjects who were discontinued from the study before randomization and subjects who were randomized to one of the six study groups. | 18 |
| GROUP 1: Continue Smoking Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days. | 40 |
| GROUP 2: OTDN Product 1 Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs) | 42 |
| GROUP 3: OTDN Product 2 Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews) | 41 |
| GROUP 4: OTDN Product 1 Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs) | 30 |
| GROUP 5: OTDN Product 2 Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews) | 30 |
| GROUP 6: Tobacco Cessation Subjects will completely stop all tobacco product usage for 7 days. | 30 |
| Total | 231 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Enrollment Closed | 5 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Failure To Meet Randomization Criteria | 13 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 2 | 0 | 1 | 5 | 3 | 3 |
Baseline characteristics
| Characteristic | Product Trial | GROUP 2: OTDN Product 1 | GROUP 3: OTDN Product 2 | GROUP 4: OTDN Product 1 | GROUP 5: OTDN Product 2 | GROUP 6: Tobacco Cessation | Total | GROUP 1: Continue Smoking |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 39.1 years STANDARD_DEVIATION 11.48 | 39.8 years STANDARD_DEVIATION 11.6 | 43.7 years STANDARD_DEVIATION 12.29 | 38.3 years STANDARD_DEVIATION 12.62 | 38.2 years STANDARD_DEVIATION 13.09 | 41.5 years STANDARD_DEVIATION 8.11 | 39.8 years STANDARD_DEVIATION 11.72 | 36.6 years STANDARD_DEVIATION 11.07 |
| Annual Income $100,000 - $149,999 | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants |
| Annual Income $20,000 - $29,999 | 3 Participants | 13 Participants | 12 Participants | 7 Participants | 13 Participants | 3 Participants | 60 Participants | 9 Participants |
| Annual Income $30,000 - $39,999 | 4 Participants | 8 Participants | 11 Participants | 6 Participants | 3 Participants | 5 Participants | 41 Participants | 4 Participants |
| Annual Income $40,000 - $49,999 | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 2 Participants | 9 Participants | 1 Participants |
| Annual Income $50,000 - $59,999 | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 7 Participants | 3 Participants |
| Annual Income $60,000 - $74,999 | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 4 Participants | 11 Participants | 4 Participants |
| Annual Income $75,000 - $99,999 | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 4 Participants | 2 Participants |
| Annual Income Do Not Wish to Answer | 0 Participants | 4 Participants | 1 Participants | 2 Participants | 0 Participants | 2 Participants | 10 Participants | 1 Participants |
| Annual Income Under $20,000 | 8 Participants | 13 Participants | 14 Participants | 13 Participants | 10 Participants | 13 Participants | 87 Participants | 16 Participants |
| Body Mass Index (BMI) | 27.656 kg/m² STANDARD_DEVIATION 5.3195 | 28.679 kg/m² STANDARD_DEVIATION 4.6677 | 29.134 kg/m² STANDARD_DEVIATION 5.4869 | 28.847 kg/m² STANDARD_DEVIATION 5.3881 | 26.670 kg/m² STANDARD_DEVIATION 5.1232 | 29.693 kg/m² STANDARD_DEVIATION 4.7754 | 28.547 kg/m² STANDARD_DEVIATION 5.0294 | 28.130 kg/m² STANDARD_DEVIATION 4.6162 |
| Cigarette Brand Style History Summary BERLEY, MENTHOL, GREEN, 100mm (100s) | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants |
| Cigarette Brand Style History Summary BERLEY, NON MENTHOL, GOLD, 85mm (Kings) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Cigarette Brand Style History Summary CAMEL, MENTHOL, CRUSH, 85mm (Kings) | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants | 0 Participants |
| Cigarette Brand Style History Summary CAMEL, MENTHOL, CRUSH SILVER, 85mm (Kings) | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 4 Participants | 0 Participants |
| Cigarette Brand Style History Summary CAMEL, MENTHOL, WIDES DARK GREEN, 85mm (Kings) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Cigarette Brand Style History Summary CAMEL, NON MENTHOL, BLUE, 85mm (Kings) | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants |
| Cigarette Brand Style History Summary CAMEL, NON MENTHOL, FILTERS, 85mm (Kings) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Cigarette Brand Style History Summary CAMEL, NON MENTHOL, TURKISH BLEND GOLD, 85mm (Kings) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Cigarette Brand Style History Summary CAMEL, NON MENTHOL, WIDES FILTERS, 85mm (Kings) | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants |
| Cigarette Brand Style History Summary CHEYENNE, MENTHOL, GREEN, 100mm (100s) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Cigarette Brand Style History Summary CHEYENNE, MENTHOL, GREEN, 85mm (Kings) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Cigarette Brand Style History Summary CHEYENNE, NON MENTHOL, RED, 100mm (100s) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Cigarette Brand Style History Summary DECADE, MENTHOL, GREEN, 100mm (100s) | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Cigarette Brand Style History Summary DECADE, NON MENTHOL, RED, 100mm (100s) | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants |
| Cigarette Brand Style History Summary EAGLE 20'S, MENTHOL, GOLD, 100mm (100s) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Cigarette Brand Style History Summary EDGEFIELD, NON MENTHOL, RED, 100mm (100s) | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Cigarette Brand Style History Summary EXETER, MENTHOL, GREEN, 100mm (100s) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Cigarette Brand Style History Summary EXETER, NON MENTHOL, KINGS (RED), 85mm (Kings) | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Cigarette Brand Style History Summary EXETER, NON MENTHOL, RED, 100mm (100s) | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Cigarette Brand Style History Summary KOOL, MENTHOL, GREEN, 100mm (100s) | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants |
| Cigarette Brand Style History Summary LIGGETT, NON MENTHOL, RED, 85mm (Kings) | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Cigarette Brand Style History Summary L&M, MENTHOL, DARK GREEN, 85mm (Kings) | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Cigarette Brand Style History Summary L&M, MENTHOL, DARK GREEN FILTER, 100mm (100s) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Cigarette Brand Style History Summary L&M, MENTHOL, DARK GREEN (GOLD PACK), 100mm (100s) | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Cigarette Brand Style History Summary L&M, MENTHOL, GREEN, 100mm (100s) | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants | 1 Participants |
| Cigarette Brand Style History Summary L&M, MENTHOL, GREEN, 85mm (Kings) | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 1 Participants |
| Cigarette Brand Style History Summary L&M, NON MENTHOL, RED, 100mm (100s) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Cigarette Brand Style History Summary L&M, NON MENTHOL, RED, 85mm (Kings) | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 5 Participants | 1 Participants |
| Cigarette Brand Style History Summary L&M, NON MENTHOL, RED FILTER, 85mm (Kings) | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Cigarette Brand Style History Summary L&M, NON MENTHOL, TURKISH BLEND GOLD, 85mm (Kings) | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants | 0 Participants |
| Cigarette Brand Style History Summary MARLBORO, MENTHOL, BLACK, 85mm (Kings) | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants | 1 Participants |
| Cigarette Brand Style History Summary MARLBORO, MENTHOL, GOLD, 100mm (100s) | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Cigarette Brand Style History Summary MARLBORO, MENTHOL, GOLD, 85mm (Kings) | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants |
| Cigarette Brand Style History Summary MARLBORO, MENTHOL, GREEN, 100mm (100s) | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Cigarette Brand Style History Summary MARLBORO, MENTHOL, GREEN, 72mm | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Cigarette Brand Style History Summary MARLBORO, MENTHOL, MIDNIGHT, 85mm (Kings) | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants |
| Cigarette Brand Style History Summary MARLBORO, MENTHOL, NXT, 85mm (Kings) | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Cigarette Brand Style History Summary MARLBORO, MENTHOL, SMOOTH, 85mm (Kings) | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants |
| Cigarette Brand Style History Summary MARLBORO, NON MENTHOL, BLACK, 100mm (100s) | 1 Participants | 1 Participants | 1 Participants | 3 Participants | 2 Participants | 0 Participants | 9 Participants | 1 Participants |
| Cigarette Brand Style History Summary MARLBORO, NON MENTHOL, BLACK, 85mm (Kings) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Cigarette Brand Style History Summary MARLBORO, NON MENTHOL, BLEND NO 27, 85mm (Kings) | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Cigarette Brand Style History Summary MARLBORO, NON MENTHOL, GOLD, 85mm (Kings) | 0 Participants | 3 Participants | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 9 Participants | 2 Participants |
| Cigarette Brand Style History Summary MARLBORO, NON MENTHOL, RED, 100mm (100s) | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 5 Participants | 2 Participants |
| Cigarette Brand Style History Summary MARLBORO, NON MENTHOL, RED, 72mm | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Cigarette Brand Style History Summary MARLBORO, NON MENTHOL, RED, 85mm (Kings) | 2 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 7 Participants | 0 Participants |
| Cigarette Brand Style History Summary MARLBORO, NON MENTHOL, RED SPECIAL SELECT, 100mm (100s) | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Cigarette Brand Style History Summary MARLBORO, NON MENTHOL, RED SPECIAL SELECT, 85mm (Kings) | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants |
| Cigarette Brand Style History Summary MARLBORO, NON MENTHOL, SOUTHERN CUT, 85mm (Kings) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Cigarette Brand Style History Summary MARLBORO, NON MENTHOL, SPECIAL BLEND GOLD, 100mm (100s) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Cigarette Brand Style History Summary MARLBORO, NON MENTHOL, SPECIAL BLEND GOLD, 85mm (Kings) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Cigarette Brand Style History Summary MARLBORO, NON MENTHOL, SPECIAL BLEND RED, 100mm (100s) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Cigarette Brand Style History Summary MARLBORO, NON MENTHOL, SPECIAL BLEND RED, 85mm (Kings) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Cigarette Brand Style History Summary MAVERICK, MENTHOL, GREEN, 100mm (100s) | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants |
| Cigarette Brand Style History Summary NATURAL AMERICAN SPIRIT, NON MENTHOL, TURQUOISE, 85mm (Kings) | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Cigarette Brand Style History Summary NATURAL AMERICAN SPIRIT, NON MENTHOL, YELLOW, 85mm (Kings) | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 4 Participants | 2 Participants |
| Cigarette Brand Style History Summary NEWPORT, MENTHOL, BLUE, 85mm (Kings) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Cigarette Brand Style History Summary NEWPORT, MENTHOL, GREEN, 100mm (100s) | 4 Participants | 12 Participants | 16 Participants | 8 Participants | 8 Participants | 8 Participants | 65 Participants | 9 Participants |
| Cigarette Brand Style History Summary NEWPORT, MENTHOL, GREEN, 72mm | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Cigarette Brand Style History Summary NEWPORT, MENTHOL, GREEN, 85mm (Kings) | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 2 Participants | 6 Participants | 13 Participants | 2 Participants |
| Cigarette Brand Style History Summary NEWPORT, NON MENTHOL, GOLD, 100mm (100s) | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Cigarette Brand Style History Summary NEWPORT, NON MENTHOL, RED, 100mm (100s) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Cigarette Brand Style History Summary NEWPORT, NON MENTHOL, RED, 85mm (Kings) | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants |
| Cigarette Brand Style History Summary PALL MALL, MENTHOL, BLACK, 100mm (100s) | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Cigarette Brand Style History Summary PALL MALL, MENTHOL, GREEN, 100mm (100s) | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants | 1 Participants |
| Cigarette Brand Style History Summary PALL MALL, MENTHOL, GREEN, 85mm (Kings) | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants |
| Cigarette Brand Style History Summary PALL MALL, MENTHOL, WHITE, 100mm (100s) | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Cigarette Brand Style History Summary PALL MALL, NON MENTHOL, BLUE, 100mm (100s) | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 6 Participants | 1 Participants |
| Cigarette Brand Style History Summary PALL MALL, NON MENTHOL, BLUE, 85mm (Kings) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Cigarette Brand Style History Summary PALL MALL, NON MENTHOL, RED, 100mm (100s) | 0 Participants | 1 Participants | 3 Participants | 1 Participants | 2 Participants | 1 Participants | 10 Participants | 2 Participants |
| Cigarette Brand Style History Summary PALL MALL, NON MENTHOL, RED, 85mm (Kings) | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants |
| Cigarette Brand Style History Summary PALL MALL, NON MENTHOL, RED FILTER, 100mm (100s) | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Cigarette Brand Style History Summary PYRAMID, NON MENTHOL, RED, 72mm | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Cigarette Brand Style History Summary SIGNAL, NON MENTHOL, RED, 85mm (Kings) | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Cigarette Brand Style History Summary USA GOLD, NON MENTHOL, GOLD, 85mm (Kings) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Cigarette Brand Style History Summary WINSTON, NON MENTHOL, GOLD, 85mm (Kings) | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Cigarette Brand Style History Summary WINSTON, NON MENTHOL, RED, 85mm (Kings) | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Daily Cigarette Use | 16.8 Cigarettes per day STANDARD_DEVIATION 5.92 | 17.8 Cigarettes per day STANDARD_DEVIATION 6.02 | 18.4 Cigarettes per day STANDARD_DEVIATION 5.99 | 15.9 Cigarettes per day STANDARD_DEVIATION 3.53 | 16.7 Cigarettes per day STANDARD_DEVIATION 5.35 | 17.8 Cigarettes per day STANDARD_DEVIATION 5.9 | 17.3 Cigarettes per day STANDARD_DEVIATION 5.37 | 16.8 Cigarettes per day STANDARD_DEVIATION 4.61 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 4 Participants | 3 Participants | 4 Participants | 1 Participants | 2 Participants | 19 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 38 Participants | 38 Participants | 26 Participants | 29 Participants | 28 Participants | 212 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Fagerström Test for Cigarette Dependence | 5.2 points STANDARD_DEVIATION 2.13 | 5.4 points STANDARD_DEVIATION 1.62 | 5.2 points STANDARD_DEVIATION 1.87 | 5.4 points STANDARD_DEVIATION 1.43 | 5.6 points STANDARD_DEVIATION 1.28 | 5.6 points STANDARD_DEVIATION 1.61 | 5.5 points STANDARD_DEVIATION 1.62 | 5.9 points STANDARD_DEVIATION 1.76 |
| Height | 168.6 cm STANDARD_DEVIATION 10.19 | 171.7 cm STANDARD_DEVIATION 8.96 | 172.2 cm STANDARD_DEVIATION 9.36 | 170.4 cm STANDARD_DEVIATION 9.86 | 171.6 cm STANDARD_DEVIATION 8.32 | 171.3 cm STANDARD_DEVIATION 9.15 | 171.7 cm STANDARD_DEVIATION 8.82 | 172.7 cm STANDARD_DEVIATION 7.69 |
| Highest Grade of School 1-3 Years College | 8 Participants | 12 Participants | 16 Participants | 4 Participants | 9 Participants | 10 Participants | 72 Participants | 13 Participants |
| Highest Grade of School 4+ Years College | 2 Participants | 4 Participants | 0 Participants | 1 Participants | 4 Participants | 4 Participants | 16 Participants | 1 Participants |
| Highest Grade of School Do Not Wish to Answer | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Highest Grade of School Elementary School | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 7 Participants | 4 Participants |
| Highest Grade of School High School Graduate | 5 Participants | 19 Participants | 19 Participants | 17 Participants | 11 Participants | 13 Participants | 101 Participants | 17 Participants |
| Highest Grade of School Other | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Highest Grade of School Postgraduate/Masters/Doctorate/Law/MD | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 6 Participants | 2 Participants |
| Highest Grade of School Some High School | 2 Participants | 4 Participants | 5 Participants | 5 Participants | 6 Participants | 2 Participants | 27 Participants | 3 Participants |
| Race/Ethnicity, Customized American Indian and Black | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian, Black, White | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian, White | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 5 Participants | 14 Participants | 14 Participants | 8 Participants | 12 Participants | 14 Participants | 80 Participants | 13 Participants |
| Race/Ethnicity, Customized Black, White | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 12 Participants | 26 Participants | 22 Participants | 22 Participants | 18 Participants | 16 Participants | 143 Participants | 27 Participants |
| Sex: Female, Male Female | 10 Participants | 19 Participants | 15 Participants | 15 Participants | 12 Participants | 12 Participants | 96 Participants | 13 Participants |
| Sex: Female, Male Male | 8 Participants | 23 Participants | 26 Participants | 15 Participants | 18 Participants | 18 Participants | 135 Participants | 27 Participants |
| Weight | 78.46 kg STANDARD_DEVIATION 15.918 | 84.81 kg STANDARD_DEVIATION 16.063 | 86.75 kg STANDARD_DEVIATION 19.738 | 83.84 kg STANDARD_DEVIATION 18.142 | 78.57 kg STANDARD_DEVIATION 15.467 | 86.82 kg STANDARD_DEVIATION 13.22 | 84.31 kg STANDARD_DEVIATION 16.614 | 84.07 kg STANDARD_DEVIATION 15.491 |
| Years Smoked | 19.4 years STANDARD_DEVIATION 13.23 | 18.9 years STANDARD_DEVIATION 12.22 | 23.6 years STANDARD_DEVIATION 13.68 | 21.7 years STANDARD_DEVIATION 13.38 | 12.93 years STANDARD_DEVIATION 12.93 | 22.2 years STANDARD_DEVIATION 9.36 | 20.8 years STANDARD_DEVIATION 12.32 | 17.6 years STANDARD_DEVIATION 11.33 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 40 | 0 / 42 | 0 / 41 | 0 / 30 | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 66 / 231 | 6 / 40 | 12 / 42 | 14 / 41 | 14 / 30 | 14 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 18 | 0 / 40 | 0 / 42 | 0 / 41 | 0 / 30 | 0 / 30 | 0 / 30 |
Outcome results
Primary
Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population)
Summary of urine total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) amount excreted (ng/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the lower limit of quantitation (LLOQ) (2.00 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Time frame: Baseline (Day -1), Day 5 and Day 7
Population: Modified ITT (mITT): All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -24.795 ng/24 hour | Standard Deviation 86.281 |
| GROUP 1: Continue Smoking | Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 487.095 ng/24 hour | Standard Deviation 276.4866 |
| GROUP 1: Continue Smoking | Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 511.889 ng/24 hour | Standard Deviation 273.0646 |
| GROUP 1: Continue Smoking | Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -35.816 ng/24 hour | Standard Deviation 85.0846 |
| GROUP 1: Continue Smoking | Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 476.074 ng/24 hour | Standard Deviation 296.5802 |
| GROUP 2: OTDN Product 1 | Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 378.601 ng/24 hour | Standard Deviation 225.028 |
| GROUP 2: OTDN Product 1 | Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -203.075 ng/24 hour | Standard Deviation 210.6622 |
| GROUP 2: OTDN Product 1 | Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 581.676 ng/24 hour | Standard Deviation 317.8968 |
| GROUP 2: OTDN Product 1 | Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -173.010 ng/24 hour | Standard Deviation 172.5258 |
| GROUP 2: OTDN Product 1 | Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 389.094 ng/24 hour | Standard Deviation 226.8891 |
| GROUP 3: OTDN Product 2 | Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 412.952 ng/24 hour | Standard Deviation 252.945 |
| GROUP 3: OTDN Product 2 | Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -135.800 ng/24 hour | Standard Deviation 143.052 |
| GROUP 3: OTDN Product 2 | Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -154.497 ng/24 hour | Standard Deviation 120.7393 |
| GROUP 3: OTDN Product 2 | Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 394.254 ng/24 hour | Standard Deviation 240.8056 |
| GROUP 3: OTDN Product 2 | Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 548.751 ng/24 hour | Standard Deviation 259.9637 |
| GROUP 4: OTDN Product 1 | Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 167.289 ng/24 hour | Standard Deviation 100.1691 |
| GROUP 4: OTDN Product 1 | Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 638.849 ng/24 hour | Standard Deviation 309.236 |
| GROUP 4: OTDN Product 1 | Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 189.353 ng/24 hour | Standard Deviation 109.4009 |
| GROUP 4: OTDN Product 1 | Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -449.496 ng/24 hour | Standard Deviation 257.2221 |
| GROUP 4: OTDN Product 1 | Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -460.402 ng/24 hour | Standard Deviation 263.391 |
| GROUP 5: OTDN Product 2 | Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -364.786 ng/24 hour | Standard Deviation 235.7564 |
| GROUP 5: OTDN Product 2 | Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 599.162 ng/24 hour | Standard Deviation 387.2946 |
| GROUP 5: OTDN Product 2 | Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -407.814 ng/24 hour | Standard Deviation 259.3657 |
| GROUP 5: OTDN Product 2 | Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 234.376 ng/24 hour | Standard Deviation 183.1248 |
| GROUP 5: OTDN Product 2 | Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 176.869 ng/24 hour | Standard Deviation 135.1699 |
| GROUP 6: Tobacco Cessation | Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 527.260 ng/24 hour | Standard Deviation 208.6977 |
| GROUP 6: Tobacco Cessation | Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -357.958 ng/24 hour | Standard Deviation 169.8953 |
| GROUP 6: Tobacco Cessation | Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 169.303 ng/24 hour | Standard Deviation 77.4737 |
| GROUP 6: Tobacco Cessation | Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -371.172 ng/24 hour | Standard Deviation 162.2706 |
| GROUP 6: Tobacco Cessation | Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 146.405 ng/24 hour | Standard Deviation 60.3849 |
Comparison: Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [5.976, 6.255]Mixed Models Analysis
Comparison: Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [5.963, 6.183]Mixed Models Analysis
Comparison: Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [5.605, 5.868]Mixed Models Analysis
Comparison: Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [5.687, 5.897]Mixed Models Analysis
Comparison: Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [5.701, 5.969]Mixed Models Analysis
Comparison: Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [5.694, 5.904]Mixed Models Analysis
Comparison: Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [4.713, 5.048]Mixed Models Analysis
Comparison: Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [4.711, 4.977]Mixed Models Analysis
Comparison: Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [5.021, 5.35]Mixed Models Analysis
Comparison: Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [4.801, 5.066]Mixed Models Analysis
Comparison: Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [4.852, 5.175]Mixed Models Analysis
Comparison: Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [4.763, 5.02]Mixed Models Analysis
Comparison: Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: 0.001395% CI: [-0.646, -0.112]Mixed Models Analysis
Comparison: Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: 0.003495% CI: [-0.496, -0.065]Mixed Models Analysis
Comparison: Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: 0.035495% CI: [-0.549, -0.012]Mixed Models Analysis
Comparison: Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: 0.004495% CI: [-0.489, -0.059]Mixed Models Analysis
Comparison: Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: <0.000195% CI: [-1.539, -0.93]Mixed Models Analysis
Comparison: Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-1.475, -0.983]Mixed Models Analysis
Comparison: Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: <0.000195% CI: [-1.23, -0.63]Mixed Models Analysis
Comparison: Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-1.383, -0.896]Mixed Models Analysis
Comparison: Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: <0.000195% CI: [0.436, 1.009]Mixed Models Analysis
Comparison: Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: <0.000195% CI: [0.667, 1.134]Mixed Models Analysis
Comparison: Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: <0.000195% CI: [0.533, 1.109]Mixed Models Analysis
Comparison: Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: <0.000195% CI: [0.675, 1.14]Mixed Models Analysis
Comparison: Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 0.829195% CI: [-0.453, 0.188]Mixed Models Analysis
Comparison: Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 0.999795% CI: [-0.308, 0.213]Mixed Models Analysis
Comparison: Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 0.575595% CI: [-0.145, 0.488]Mixed Models Analysis
Comparison: Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 0.999995% CI: [-0.217, 0.301]Mixed Models Analysis
Primary
Summary of Urine Total NNAL Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Summary of urine total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (2.00 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %
Time frame: Day 5 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of Urine Total NNAL Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -4.241 percentage of change | Standard Deviation 22.091 |
| GROUP 1: Continue Smoking | Summary of Urine Total NNAL Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -8.377 percentage of change | Standard Deviation 20.0357 |
| GROUP 2: OTDN Product 1 | Summary of Urine Total NNAL Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -31.755 percentage of change | Standard Deviation 28.5666 |
| GROUP 2: OTDN Product 1 | Summary of Urine Total NNAL Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -29.261 percentage of change | Standard Deviation 20.2229 |
| GROUP 3: OTDN Product 2 | Summary of Urine Total NNAL Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -26.092 percentage of change | Standard Deviation 23.2887 |
| GROUP 3: OTDN Product 2 | Summary of Urine Total NNAL Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -29.854 percentage of change | Standard Deviation 17.715 |
| GROUP 4: OTDN Product 1 | Summary of Urine Total NNAL Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -66.540 percentage of change | Standard Deviation 18.5833 |
| GROUP 4: OTDN Product 1 | Summary of Urine Total NNAL Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -70.823 percentage of change | Standard Deviation 13.8839 |
| GROUP 5: OTDN Product 2 | Summary of Urine Total NNAL Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -61.140 percentage of change | Standard Deviation 14.0247 |
| GROUP 5: OTDN Product 2 | Summary of Urine Total NNAL Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -68.763 percentage of change | Standard Deviation 16.4492 |
| GROUP 6: Tobacco Cessation | Summary of Urine Total NNAL Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -67.092 percentage of change | Standard Deviation 11.74 |
| GROUP 6: Tobacco Cessation | Summary of Urine Total NNAL Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -71.244 percentage of change | Standard Deviation 8.1469 |
Secondary
Cigarette Consumption by Study Group and Study Day (mITT Population)
Summary of cigarette consumption, as number of cigarettes smoked per day (CPD), by study group and study day is presented. Baseline = Average of Days -2 and -1.
Time frame: Day -1 and Day -2 (Baseline), Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure.~Subjects in Groups 4, 5, and 6 were instructed to refrain from smoking cigarettes after Day -1 in compliance with the product use group assignment. No CPD data was collected for these groups on Days 1 through 7 and the Number of Participants Analyzed is reported as '0' in the data table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Cigarette Consumption by Study Group and Study Day (mITT Population) | Day 7 | 17.1 cigarettes per day | Standard Deviation 4.43 |
| GROUP 1: Continue Smoking | Cigarette Consumption by Study Group and Study Day (mITT Population) | Day -2 | 16.6 cigarettes per day | Standard Deviation 3.8 |
| GROUP 1: Continue Smoking | Cigarette Consumption by Study Group and Study Day (mITT Population) | Day -1 | 17.4 cigarettes per day | Standard Deviation 4.52 |
| GROUP 1: Continue Smoking | Cigarette Consumption by Study Group and Study Day (mITT Population) | Baseline | 17.00 cigarettes per day | Standard Deviation 3.958 |
| GROUP 1: Continue Smoking | Cigarette Consumption by Study Group and Study Day (mITT Population) | Day 1 | 16.4 cigarettes per day | Standard Deviation 3.71 |
| GROUP 1: Continue Smoking | Cigarette Consumption by Study Group and Study Day (mITT Population) | Day 2 | 16.0 cigarettes per day | Standard Deviation 3.7 |
| GROUP 1: Continue Smoking | Cigarette Consumption by Study Group and Study Day (mITT Population) | Day 3 | 15.7 cigarettes per day | Standard Deviation 4.51 |
| GROUP 1: Continue Smoking | Cigarette Consumption by Study Group and Study Day (mITT Population) | Day 4 | 15.7 cigarettes per day | Standard Deviation 3.88 |
| GROUP 1: Continue Smoking | Cigarette Consumption by Study Group and Study Day (mITT Population) | Day 5 | 16.1 cigarettes per day | Standard Deviation 4.51 |
| GROUP 1: Continue Smoking | Cigarette Consumption by Study Group and Study Day (mITT Population) | Day 6 | 15.5 cigarettes per day | Standard Deviation 4 |
| GROUP 2: OTDN Product 1 | Cigarette Consumption by Study Group and Study Day (mITT Population) | Day 1 | 8.1 cigarettes per day | Standard Deviation 2.14 |
| GROUP 2: OTDN Product 1 | Cigarette Consumption by Study Group and Study Day (mITT Population) | Day 5 | 8.2 cigarettes per day | Standard Deviation 2.27 |
| GROUP 2: OTDN Product 1 | Cigarette Consumption by Study Group and Study Day (mITT Population) | Baseline | 17.17 cigarettes per day | Standard Deviation 4.131 |
| GROUP 2: OTDN Product 1 | Cigarette Consumption by Study Group and Study Day (mITT Population) | Day 2 | 8.2 cigarettes per day | Standard Deviation 2.35 |
| GROUP 2: OTDN Product 1 | Cigarette Consumption by Study Group and Study Day (mITT Population) | Day -1 | 17.6 cigarettes per day | Standard Deviation 4.52 |
| GROUP 2: OTDN Product 1 | Cigarette Consumption by Study Group and Study Day (mITT Population) | Day 6 | 8.2 cigarettes per day | Standard Deviation 2.14 |
| GROUP 2: OTDN Product 1 | Cigarette Consumption by Study Group and Study Day (mITT Population) | Day -2 | 16.7 cigarettes per day | Standard Deviation 4.15 |
| GROUP 2: OTDN Product 1 | Cigarette Consumption by Study Group and Study Day (mITT Population) | Day 4 | 8.1 cigarettes per day | Standard Deviation 2.2 |
| GROUP 2: OTDN Product 1 | Cigarette Consumption by Study Group and Study Day (mITT Population) | Day 3 | 8.2 cigarettes per day | Standard Deviation 2.09 |
| GROUP 2: OTDN Product 1 | Cigarette Consumption by Study Group and Study Day (mITT Population) | Day 7 | 8.2 cigarettes per day | Standard Deviation 2.1 |
| GROUP 3: OTDN Product 2 | Cigarette Consumption by Study Group and Study Day (mITT Population) | Day -1 | 18.8 cigarettes per day | Standard Deviation 6.17 |
| GROUP 3: OTDN Product 2 | Cigarette Consumption by Study Group and Study Day (mITT Population) | Baseline | 18.33 cigarettes per day | Standard Deviation 5.197 |
| GROUP 3: OTDN Product 2 | Cigarette Consumption by Study Group and Study Day (mITT Population) | Day 5 | 8.6 cigarettes per day | Standard Deviation 2.61 |
| GROUP 3: OTDN Product 2 | Cigarette Consumption by Study Group and Study Day (mITT Population) | Day 1 | 8.8 cigarettes per day | Standard Deviation 2.51 |
| GROUP 3: OTDN Product 2 | Cigarette Consumption by Study Group and Study Day (mITT Population) | Day 7 | 8.8 cigarettes per day | Standard Deviation 2.67 |
| GROUP 3: OTDN Product 2 | Cigarette Consumption by Study Group and Study Day (mITT Population) | Day 2 | 8.7 cigarettes per day | Standard Deviation 2.54 |
| GROUP 3: OTDN Product 2 | Cigarette Consumption by Study Group and Study Day (mITT Population) | Day 3 | 8.8 cigarettes per day | Standard Deviation 2.54 |
| GROUP 3: OTDN Product 2 | Cigarette Consumption by Study Group and Study Day (mITT Population) | Day 6 | 8.7 cigarettes per day | Standard Deviation 2.58 |
| GROUP 3: OTDN Product 2 | Cigarette Consumption by Study Group and Study Day (mITT Population) | Day 4 | 8.7 cigarettes per day | Standard Deviation 2.53 |
| GROUP 3: OTDN Product 2 | Cigarette Consumption by Study Group and Study Day (mITT Population) | Day -2 | 17.8 cigarettes per day | Standard Deviation 4.82 |
| GROUP 4: OTDN Product 1 | Cigarette Consumption by Study Group and Study Day (mITT Population) | Day -2 | 16.7 cigarettes per day | Standard Deviation 4.95 |
| GROUP 4: OTDN Product 1 | Cigarette Consumption by Study Group and Study Day (mITT Population) | Baseline | 17.02 cigarettes per day | Standard Deviation 4.568 |
| GROUP 4: OTDN Product 1 | Cigarette Consumption by Study Group and Study Day (mITT Population) | Day -1 | 17.3 cigarettes per day | Standard Deviation 4.67 |
| GROUP 5: OTDN Product 2 | Cigarette Consumption by Study Group and Study Day (mITT Population) | Baseline | 16.89 cigarettes per day | Standard Deviation 4.661 |
| GROUP 5: OTDN Product 2 | Cigarette Consumption by Study Group and Study Day (mITT Population) | Day -2 | 16.8 cigarettes per day | Standard Deviation 5.08 |
| GROUP 5: OTDN Product 2 | Cigarette Consumption by Study Group and Study Day (mITT Population) | Day -1 | 17.0 cigarettes per day | Standard Deviation 4.73 |
| GROUP 6: Tobacco Cessation | Cigarette Consumption by Study Group and Study Day (mITT Population) | Day -2 | 16.2 cigarettes per day | Standard Deviation 3.68 |
| GROUP 6: Tobacco Cessation | Cigarette Consumption by Study Group and Study Day (mITT Population) | Day -1 | 17.5 cigarettes per day | Standard Deviation 4.2 |
| GROUP 6: Tobacco Cessation | Cigarette Consumption by Study Group and Study Day (mITT Population) | Baseline | 16.82 cigarettes per day | Standard Deviation 3.735 |
Secondary
Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Summary of 1-hydroxypyrene (1-OHP) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.01 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Time frame: Baseline (Day -1), Day 5 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 0.463 ug/24 hour | Standard Deviation 0.4552 |
| GROUP 1: Continue Smoking | Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 0.428 ug/24 hour | Standard Deviation 0.285 |
| GROUP 1: Continue Smoking | Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 0.377 ug/24 hour | Standard Deviation 0.197 |
| GROUP 1: Continue Smoking | Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -0.034 ug/24 hour | Standard Deviation 0.4123 |
| GROUP 1: Continue Smoking | Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -0.085 ug/24 hour | Standard Deviation 0.3795 |
| GROUP 2: OTDN Product 1 | Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 0.446 ug/24 hour | Standard Deviation 0.2545 |
| GROUP 2: OTDN Product 1 | Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 0.352 ug/24 hour | Standard Deviation 0.2555 |
| GROUP 2: OTDN Product 1 | Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -0.066 ug/24 hour | Standard Deviation 0.2799 |
| GROUP 2: OTDN Product 1 | Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -0.077 ug/24 hour | Standard Deviation 0.2851 |
| GROUP 2: OTDN Product 1 | Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 0.380 ug/24 hour | Standard Deviation 0.2917 |
| GROUP 3: OTDN Product 2 | Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 0.451 ug/24 hour | Standard Deviation 0.3757 |
| GROUP 3: OTDN Product 2 | Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -0.141 ug/24 hour | Standard Deviation 0.3754 |
| GROUP 3: OTDN Product 2 | Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 0.454 ug/24 hour | Standard Deviation 0.2575 |
| GROUP 3: OTDN Product 2 | Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -0.138 ug/24 hour | Standard Deviation 0.3833 |
| GROUP 3: OTDN Product 2 | Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 0.592 ug/24 hour | Standard Deviation 0.4884 |
| GROUP 4: OTDN Product 1 | Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 0.483 ug/24 hour | Standard Deviation 0.4287 |
| GROUP 4: OTDN Product 1 | Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 0.688 ug/24 hour | Standard Deviation 0.6987 |
| GROUP 4: OTDN Product 1 | Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 0.407 ug/24 hour | Standard Deviation 0.3324 |
| GROUP 4: OTDN Product 1 | Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -0.281 ug/24 hour | Standard Deviation 0.6769 |
| GROUP 4: OTDN Product 1 | Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -0.213 ug/24 hour | Standard Deviation 0.6848 |
| GROUP 5: OTDN Product 2 | Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -0.135 ug/24 hour | Standard Deviation 0.3196 |
| GROUP 5: OTDN Product 2 | Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 0.473 ug/24 hour | Standard Deviation 0.2597 |
| GROUP 5: OTDN Product 2 | Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -0.094 ug/24 hour | Standard Deviation 0.3427 |
| GROUP 5: OTDN Product 2 | Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 0.338 ug/24 hour | Standard Deviation 0.2872 |
| GROUP 5: OTDN Product 2 | Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 0.371 ug/24 hour | Standard Deviation 0.3406 |
| GROUP 6: Tobacco Cessation | Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 0.446 ug/24 hour | Standard Deviation 0.2616 |
| GROUP 6: Tobacco Cessation | Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -0.132 ug/24 hour | Standard Deviation 0.295 |
| GROUP 6: Tobacco Cessation | Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 0.314 ug/24 hour | Standard Deviation 0.2238 |
| GROUP 6: Tobacco Cessation | Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | 0.010 ug/24 hour | Standard Deviation 0.345 |
| GROUP 6: Tobacco Cessation | Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 0.440 ug/24 hour | Standard Deviation 0.4277 |
Comparison: Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [-1.146, -0.75]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [-1.242, -0.796]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [-1.358, -0.986]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [-1.409, -0.983]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [-1.239, -0.859]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [-1.414, -0.986]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [-1.574, -1.099]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [-1.616, -1.075]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [-1.685, -1.219]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [-1.608, -1.071]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [-1.577, -1.118]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [-1.488, -0.966]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: 0.564695% CI: [-0.607, 0.16]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: 0.876595% CI: [-0.609, 0.254]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: 0.995495% CI: [-0.488, 0.287]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: 0.866595% CI: [-0.613, 0.252]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: 0.116595% CI: [-0.829, 0.052]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: 0.389695% CI: [-0.821, 0.168]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: 0.012295% CI: [-0.934, -0.074]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: 0.393895% CI: [-0.807, 0.167]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 0.850195% CI: [-0.237, 0.589]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 195% CI: [-0.435, 0.496]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 0.292895% CI: [-0.117, 0.715]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 195% CI: [-0.439, 0.493]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 195% CI: [-0.453, 0.475]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 0.996695% CI: [-0.64, 0.403]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 0.997695% CI: [-0.56, 0.352]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 0.997695% CI: [-0.628, 0.404]Mixed Models Analysis
Secondary
Summary of 1-OHP Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Summary of 1-hydroxypyrene (1-OHP) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.01 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %
Time frame: Day 5 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of 1-OHP Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | 14.604 percentage of change | Standard Deviation 64.3632 |
| GROUP 1: Continue Smoking | Summary of 1-OHP Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | 1.713 percentage of change | Standard Deviation 40.2284 |
| GROUP 2: OTDN Product 1 | Summary of 1-OHP Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -9.171 percentage of change | Standard Deviation 55.4282 |
| GROUP 2: OTDN Product 1 | Summary of 1-OHP Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -9.849 percentage of change | Standard Deviation 58.6387 |
| GROUP 3: OTDN Product 2 | Summary of 1-OHP Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -3.632 percentage of change | Standard Deviation 63.0769 |
| GROUP 3: OTDN Product 2 | Summary of 1-OHP Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -15.538 percentage of change | Standard Deviation 49.589 |
| GROUP 4: OTDN Product 1 | Summary of 1-OHP Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -22.640 percentage of change | Standard Deviation 46.8991 |
| GROUP 4: OTDN Product 1 | Summary of 1-OHP Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -18.133 percentage of change | Standard Deviation 51.844 |
| GROUP 5: OTDN Product 2 | Summary of 1-OHP Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -19.442 percentage of change | Standard Deviation 63.1149 |
| GROUP 5: OTDN Product 2 | Summary of 1-OHP Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -10.328 percentage of change | Standard Deviation 72.1902 |
| GROUP 6: Tobacco Cessation | Summary of 1-OHP Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -9.058 percentage of change | Standard Deviation 94.5456 |
| GROUP 6: Tobacco Cessation | Summary of 1-OHP Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | 1.959 percentage of change | Standard Deviation 68.3664 |
Secondary
Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Summary of 1-OH-Phenanthrene (1-OHPhe) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.005 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Time frame: Baseline (Day -1), Day 5 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -0.013 ug/24 hour | Standard Deviation 0.111 |
| GROUP 1: Continue Smoking | Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 0.278 ug/24 hour | Standard Deviation 0.1902 |
| GROUP 1: Continue Smoking | Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 0.291 ug/24 hour | Standard Deviation 0.1655 |
| GROUP 1: Continue Smoking | Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -0.018 ug/24 hour | Standard Deviation 0.1123 |
| GROUP 1: Continue Smoking | Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 0.273 ug/24 hour | Standard Deviation 0.1779 |
| GROUP 2: OTDN Product 1 | Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 0.206 ug/24 hour | Standard Deviation 0.1019 |
| GROUP 2: OTDN Product 1 | Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -0.119 ug/24 hour | Standard Deviation 0.1104 |
| GROUP 2: OTDN Product 1 | Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 0.325 ug/24 hour | Standard Deviation 0.1332 |
| GROUP 2: OTDN Product 1 | Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -0.133 ug/24 hour | Standard Deviation 0.0954 |
| GROUP 2: OTDN Product 1 | Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 0.190 ug/24 hour | Standard Deviation 0.0833 |
| GROUP 3: OTDN Product 2 | Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 0.214 ug/24 hour | Standard Deviation 0.0966 |
| GROUP 3: OTDN Product 2 | Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -0.110 ug/24 hour | Standard Deviation 0.1535 |
| GROUP 3: OTDN Product 2 | Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -0.134 ug/24 hour | Standard Deviation 0.1253 |
| GROUP 3: OTDN Product 2 | Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 0.190 ug/24 hour | Standard Deviation 0.1011 |
| GROUP 3: OTDN Product 2 | Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 0.324 ug/24 hour | Standard Deviation 0.1591 |
| GROUP 4: OTDN Product 1 | Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 0.126 ug/24 hour | Standard Deviation 0.0827 |
| GROUP 4: OTDN Product 1 | Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 0.342 ug/24 hour | Standard Deviation 0.1495 |
| GROUP 4: OTDN Product 1 | Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 0.147 ug/24 hour | Standard Deviation 0.1357 |
| GROUP 4: OTDN Product 1 | Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -0.195 ug/24 hour | Standard Deviation 0.2001 |
| GROUP 4: OTDN Product 1 | Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -0.209 ug/24 hour | Standard Deviation 0.1597 |
| GROUP 5: OTDN Product 2 | Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -0.172 ug/24 hour | Standard Deviation 0.1313 |
| GROUP 5: OTDN Product 2 | Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 0.273 ug/24 hour | Standard Deviation 0.156 |
| GROUP 5: OTDN Product 2 | Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -0.182 ug/24 hour | Standard Deviation 0.1308 |
| GROUP 5: OTDN Product 2 | Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 0.101 ug/24 hour | Standard Deviation 0.0567 |
| GROUP 5: OTDN Product 2 | Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 0.095 ug/24 hour | Standard Deviation 0.0546 |
| GROUP 6: Tobacco Cessation | Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 0.348 ug/24 hour | Standard Deviation 0.187 |
| GROUP 6: Tobacco Cessation | Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -0.217 ug/24 hour | Standard Deviation 0.1672 |
| GROUP 6: Tobacco Cessation | Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 0.131 ug/24 hour | Standard Deviation 0.0617 |
| GROUP 6: Tobacco Cessation | Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -0.185 ug/24 hour | Standard Deviation 0.1665 |
| GROUP 6: Tobacco Cessation | Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 0.149 ug/24 hour | Standard Deviation 0.0923 |
Comparison: Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [-1.604, -1.279]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [-1.576, -1.251]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [-1.907, -1.6]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [-1.972, -1.659]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [-1.81, -1.498]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [-1.986, -1.673]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [-2.379, -1.989]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [-2.468, -2.071]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [-2.607, -2.219]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [-2.549, -2.149]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [-2.416, -2.038]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [-2.345, -1.962]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: 0.055295% CI: [-0.628, 0.004]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: 0.005595% CI: [-0.722, -0.083]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: 0.383495% CI: [-0.53, 0.105]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: 0.003395% CI: [-0.734, -0.099]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: <0.000195% CI: [-1.103, -0.382]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-1.22, -0.493]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: <0.000195% CI: [-1.327, -0.616]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-1.298, -0.574]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 0.001695% CI: [0.133, 0.813]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 0.058295% CI: [-0.007, 0.683]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: <0.000195% CI: [0.232, 0.914]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 0.074595% CI: [-0.02, 0.668]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 195% CI: [-0.337, 0.422]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 0.975995% CI: [-0.501, 0.268]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 0.712895% CI: [-0.565, 0.192]Mixed Models Analysis
Comparison: Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 0.681695% CI: [-0.582, 0.192]Mixed Models Analysis
Secondary
Summary of 1-OHPhe Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Summary of 1-OH-Phenanthrene (1-OHPhe) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.005 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %
Time frame: Day 5 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of 1-OHPhe Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -2.014 percentage of change | Standard Deviation 35.7667 |
| GROUP 1: Continue Smoking | Summary of 1-OHPhe Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -3.193 percentage of change | Standard Deviation 33.298 |
| GROUP 2: OTDN Product 1 | Summary of 1-OHPhe Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -30.659 percentage of change | Standard Deviation 39.1914 |
| GROUP 2: OTDN Product 1 | Summary of 1-OHPhe Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -35.291 percentage of change | Standard Deviation 32.2576 |
| GROUP 3: OTDN Product 2 | Summary of 1-OHPhe Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -21.599 percentage of change | Standard Deviation 45.5212 |
| GROUP 3: OTDN Product 2 | Summary of 1-OHPhe Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -32.597 percentage of change | Standard Deviation 38.1268 |
| GROUP 4: OTDN Product 1 | Summary of 1-OHPhe Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -47.691 percentage of change | Standard Deviation 44.6728 |
| GROUP 4: OTDN Product 1 | Summary of 1-OHPhe Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -55.524 percentage of change | Standard Deviation 30.9398 |
| GROUP 5: OTDN Product 2 | Summary of 1-OHPhe Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -54.224 percentage of change | Standard Deviation 39.4318 |
| GROUP 5: OTDN Product 2 | Summary of 1-OHPhe Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -31.699 percentage of change | Standard Deviation 156.6252 |
| GROUP 6: Tobacco Cessation | Summary of 1-OHPhe Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -56.563 percentage of change | Standard Deviation 25.0593 |
| GROUP 6: Tobacco Cessation | Summary of 1-OHPhe Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -52.495 percentage of change | Standard Deviation 28.1468 |
Secondary
Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population)
Summary of 2-aminonaphthalene (2-AN) amount excreted (ng/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (1.7 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Time frame: Baseline (Day -1), Day 5 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -1.304 ng/24 hour | Standard Deviation 8.4746 |
| GROUP 1: Continue Smoking | Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 35.786 ng/24 hour | Standard Deviation 16.7327 |
| GROUP 1: Continue Smoking | Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 35.058 ng/24 hour | Standard Deviation 14.744 |
| GROUP 1: Continue Smoking | Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | 0.728 ng/24 hour | Standard Deviation 10.3513 |
| GROUP 1: Continue Smoking | Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 33.753 ng/24 hour | Standard Deviation 13.994 |
| GROUP 2: OTDN Product 1 | Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 21.422 ng/24 hour | Standard Deviation 13.0808 |
| GROUP 2: OTDN Product 1 | Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 20.031 ng/24 hour | Standard Deviation 8.1023 |
| GROUP 2: OTDN Product 1 | Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -17.016 ng/24 hour | Standard Deviation 15.3994 |
| GROUP 2: OTDN Product 1 | Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 38.438 ng/24 hour | Standard Deviation 16.58 |
| GROUP 2: OTDN Product 1 | Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -18.505 ng/24 hour | Standard Deviation 13.1224 |
| GROUP 3: OTDN Product 2 | Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -17.808 ng/24 hour | Standard Deviation 19.0237 |
| GROUP 3: OTDN Product 2 | Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 39.133 ng/24 hour | Standard Deviation 20.5915 |
| GROUP 3: OTDN Product 2 | Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 21.325 ng/24 hour | Standard Deviation 9.9158 |
| GROUP 3: OTDN Product 2 | Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 20.709 ng/24 hour | Standard Deviation 10.349 |
| GROUP 3: OTDN Product 2 | Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -18.424 ng/24 hour | Standard Deviation 17.5363 |
| GROUP 4: OTDN Product 1 | Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 36.900 ng/24 hour | Standard Deviation 18.4031 |
| GROUP 4: OTDN Product 1 | Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -34.140 ng/24 hour | Standard Deviation 18.8337 |
| GROUP 4: OTDN Product 1 | Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 2.757 ng/24 hour | Standard Deviation 2.6274 |
| GROUP 4: OTDN Product 1 | Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -33.896 ng/24 hour | Standard Deviation 19.2124 |
| GROUP 4: OTDN Product 1 | Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 2.760 ng/24 hour | Standard Deviation 1.6132 |
| GROUP 5: OTDN Product 2 | Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 2.085 ng/24 hour | Standard Deviation 1.0846 |
| GROUP 5: OTDN Product 2 | Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 1.777 ng/24 hour | Standard Deviation 0.8171 |
| GROUP 5: OTDN Product 2 | Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -33.335 ng/24 hour | Standard Deviation 13.4748 |
| GROUP 5: OTDN Product 2 | Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 35.420 ng/24 hour | Standard Deviation 13.9413 |
| GROUP 5: OTDN Product 2 | Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -33.997 ng/24 hour | Standard Deviation 13.1827 |
| GROUP 6: Tobacco Cessation | Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 39.841 ng/24 hour | Standard Deviation 17.9932 |
| GROUP 6: Tobacco Cessation | Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -36.606 ng/24 hour | Standard Deviation 17.8281 |
| GROUP 6: Tobacco Cessation | Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 2.849 ng/24 hour | Standard Deviation 2.2411 |
| GROUP 6: Tobacco Cessation | Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -37.431 ng/24 hour | Standard Deviation 18.0022 |
| GROUP 6: Tobacco Cessation | Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 2.410 ng/24 hour | Standard Deviation 1.2299 |
Comparison: Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [3.31, 3.63]Mixed Models Analysis
Comparison: Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [3.348, 3.668]Mixed Models Analysis
Comparison: Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [2.741, 3.042]Mixed Models Analysis
Comparison: Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [2.719, 3.027]Mixed Models Analysis
Comparison: Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [2.775, 3.082]Mixed Models Analysis
Comparison: Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [2.742, 3.049]Mixed Models Analysis
Comparison: Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [0.672, 1.055]Mixed Models Analysis
Comparison: Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [0.592, 0.981]Mixed Models Analysis
Comparison: Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [0.452, 0.829]Mixed Models Analysis
Comparison: Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [0.29, 0.68]Mixed Models Analysis
Comparison: Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [0.562, 0.932]Mixed Models Analysis
Comparison: Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [0.645, 1.021]Mixed Models Analysis
Comparison: Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: <0.000195% CI: [-0.889, -0.268]Mixed Models Analysis
Comparison: Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-0.949, -0.321]Mixed Models Analysis
Comparison: Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: <0.000195% CI: [-0.853, -0.231]Mixed Models Analysis
Comparison: Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-0.924, -0.301]Mixed Models Analysis
Comparison: Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: <0.000195% CI: [-2.959, -2.253]Mixed Models Analysis
Comparison: Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-3.078, -2.366]Mixed Models Analysis
Comparison: Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: <0.000195% CI: [-3.177, -2.481]Mixed Models Analysis
Comparison: Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-3.378, -2.669]Mixed Models Analysis
Comparison: Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: <0.000195% CI: [1.811, 2.478]Mixed Models Analysis
Comparison: Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: <0.000195% CI: [1.701, 2.379]Mixed Models Analysis
Comparison: Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: <0.000195% CI: [1.846, 2.516]Mixed Models Analysis
Comparison: Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: <0.000195% CI: [1.725, 2.4]Mixed Models Analysis
Comparison: Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 0.970595% CI: [-0.256, 0.49]Mixed Models Analysis
Comparison: Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 195% CI: [-0.425, 0.332]Mixed Models Analysis
Comparison: Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 0.983595% CI: [-0.475, 0.263]Mixed Models Analysis
Comparison: Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 0.085495% CI: [-0.725, 0.029]Mixed Models Analysis
Secondary
Summary of 2-AN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Summary of 2-aminonaphthalene (2-AN) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (1.7 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %
Time frame: Day 5 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of 2-AN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -0.214 percentage of change | Standard Deviation 26.288 |
| GROUP 1: Continue Smoking | Summary of 2-AN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | 4.815 percentage of change | Standard Deviation 36.9328 |
| GROUP 2: OTDN Product 1 | Summary of 2-AN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -41.725 percentage of change | Standard Deviation 34.1635 |
| GROUP 2: OTDN Product 1 | Summary of 2-AN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -44.657 percentage of change | Standard Deviation 15.4429 |
| GROUP 3: OTDN Product 2 | Summary of 2-AN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -29.316 percentage of change | Standard Deviation 83.0987 |
| GROUP 3: OTDN Product 2 | Summary of 2-AN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -39.152 percentage of change | Standard Deviation 34.9209 |
| GROUP 4: OTDN Product 1 | Summary of 2-AN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -90.186 percentage of change | Standard Deviation 8.2459 |
| GROUP 4: OTDN Product 1 | Summary of 2-AN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -90.671 percentage of change | Standard Deviation 9.5679 |
| GROUP 5: OTDN Product 2 | Summary of 2-AN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -93.792 percentage of change | Standard Deviation 2.8305 |
| GROUP 5: OTDN Product 2 | Summary of 2-AN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -94.813 percentage of change | Standard Deviation 1.9651 |
| GROUP 6: Tobacco Cessation | Summary of 2-AN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -93.291 percentage of change | Standard Deviation 3.3952 |
| GROUP 6: Tobacco Cessation | Summary of 2-AN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -92.289 percentage of change | Standard Deviation 5.3199 |
Secondary
Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Summary of 2-hydroxypropyl-mercapturic acid (2-HPMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (2.5 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Time frame: Baseline (Day -1), Day 5 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 100.714 ug/24 hour | Standard Deviation 51.449 |
| GROUP 1: Continue Smoking | Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 106.168 ug/24 hour | Standard Deviation 59.9458 |
| GROUP 1: Continue Smoking | Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 105.297 ug/24 hour | Standard Deviation 54.5963 |
| GROUP 1: Continue Smoking | Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | 0.871 ug/24 hour | Standard Deviation 34.9551 |
| GROUP 1: Continue Smoking | Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -4.583 ug/24 hour | Standard Deviation 21.8338 |
| GROUP 2: OTDN Product 1 | Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -39.574 ug/24 hour | Standard Deviation 33.634 |
| GROUP 2: OTDN Product 1 | Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 110.378 ug/24 hour | Standard Deviation 62.4698 |
| GROUP 2: OTDN Product 1 | Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 73.687 ug/24 hour | Standard Deviation 45.6677 |
| GROUP 2: OTDN Product 1 | Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 72.440 ug/24 hour | Standard Deviation 39.9138 |
| GROUP 2: OTDN Product 1 | Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -36.691 ug/24 hour | Standard Deviation 33.3048 |
| GROUP 3: OTDN Product 2 | Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 113.258 ug/24 hour | Standard Deviation 64.2108 |
| GROUP 3: OTDN Product 2 | Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 70.583 ug/24 hour | Standard Deviation 31.1338 |
| GROUP 3: OTDN Product 2 | Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 73.431 ug/24 hour | Standard Deviation 32.8976 |
| GROUP 3: OTDN Product 2 | Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -42.675 ug/24 hour | Standard Deviation 52.2138 |
| GROUP 3: OTDN Product 2 | Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -39.827 ug/24 hour | Standard Deviation 47.7576 |
| GROUP 4: OTDN Product 1 | Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 22.004 ug/24 hour | Standard Deviation 9.4428 |
| GROUP 4: OTDN Product 1 | Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -94.758 ug/24 hour | Standard Deviation 63.0836 |
| GROUP 4: OTDN Product 1 | Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 116.041 ug/24 hour | Standard Deviation 64.3856 |
| GROUP 4: OTDN Product 1 | Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -93.636 ug/24 hour | Standard Deviation 65.3517 |
| GROUP 4: OTDN Product 1 | Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 21.284 ug/24 hour | Standard Deviation 7.7785 |
| GROUP 5: OTDN Product 2 | Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -72.247 ug/24 hour | Standard Deviation 71.8521 |
| GROUP 5: OTDN Product 2 | Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 36.173 ug/24 hour | Standard Deviation 40.3089 |
| GROUP 5: OTDN Product 2 | Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 33.002 ug/24 hour | Standard Deviation 18.4874 |
| GROUP 5: OTDN Product 2 | Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -77.317 ug/24 hour | Standard Deviation 65.6904 |
| GROUP 5: OTDN Product 2 | Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 108.420 ug/24 hour | Standard Deviation 63.0178 |
| GROUP 6: Tobacco Cessation | Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -89.342 ug/24 hour | Standard Deviation 53.0876 |
| GROUP 6: Tobacco Cessation | Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 23.226 ug/24 hour | Standard Deviation 7.9556 |
| GROUP 6: Tobacco Cessation | Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 26.843 ug/24 hour | Standard Deviation 9.3874 |
| GROUP 6: Tobacco Cessation | Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -92.006 ug/24 hour | Standard Deviation 53.5034 |
| GROUP 6: Tobacco Cessation | Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 115.231 ug/24 hour | Standard Deviation 54.4428 |
Comparison: Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [4.383, 4.643]Mixed Models Analysis
Comparison: Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [4.371, 4.61]Mixed Models Analysis
Comparison: Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [4.027, 4.272]Mixed Models Analysis
Comparison: Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [4.014, 4.242]Mixed Models Analysis
Comparison: Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [4.051, 4.301]Mixed Models Analysis
Comparison: Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [4.024, 4.254]Mixed Models Analysis
Comparison: Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [2.842, 3.153]Mixed Models Analysis
Comparison: Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [2.849, 3.138]Mixed Models Analysis
Comparison: Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [3.164, 3.47]Mixed Models Analysis
Comparison: Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [3.199, 3.486]Mixed Models Analysis
Comparison: Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [2.886, 3.187]Mixed Models Analysis
Comparison: Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [3.019, 3.299]Mixed Models Analysis
Comparison: Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: 0.000895% CI: [-0.613, -0.113]Mixed Models Analysis
Comparison: Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: 0.000395% CI: [-0.595, -0.129]Mixed Models Analysis
Comparison: Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: 0.002695% CI: [-0.588, -0.085]Mixed Models Analysis
Comparison: Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: 0.000495% CI: [-0.584, -0.118]Mixed Models Analysis
Comparison: Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: <0.000195% CI: [-1.8, -1.23]Mixed Models Analysis
Comparison: Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-1.762, -1.231]Mixed Models Analysis
Comparison: Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: <0.000195% CI: [-1.477, -0.915]Mixed Models Analysis
Comparison: Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-1.41, -0.886]Mixed Models Analysis
Comparison: Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: <0.000195% CI: [0.844, 1.382]Mixed Models Analysis
Comparison: Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: <0.000195% CI: [0.717, 1.221]Mixed Models Analysis
Comparison: Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: <0.000195% CI: [0.869, 1.41]Mixed Models Analysis
Comparison: Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: <0.000195% CI: [0.728, 1.231]Mixed Models Analysis
Comparison: Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 195% CI: [-0.34, 0.262]Mixed Models Analysis
Comparison: Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 0.518495% CI: [-0.447, 0.115]Mixed Models Analysis
Comparison: Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 0.074395% CI: [-0.017, 0.578]Mixed Models Analysis
Comparison: Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 0.388995% CI: [-0.095, 0.462]Mixed Models Analysis
Secondary
Summary of 2-HPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Summary of 2-hydroxypropyl-mercapturic acid (2-HPMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (2.5 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %
Time frame: Day 5 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of 2-HPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | 2.576 percentage of change | Standard Deviation 35.0793 |
| GROUP 1: Continue Smoking | Summary of 2-HPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -1.857 percentage of change | Standard Deviation 20.6712 |
| GROUP 2: OTDN Product 1 | Summary of 2-HPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -30.260 percentage of change | Standard Deviation 22.7811 |
| GROUP 2: OTDN Product 1 | Summary of 2-HPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -32.286 percentage of change | Standard Deviation 15.7228 |
| GROUP 3: OTDN Product 2 | Summary of 2-HPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -28.992 percentage of change | Standard Deviation 20.1727 |
| GROUP 3: OTDN Product 2 | Summary of 2-HPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -30.611 percentage of change | Standard Deviation 19.9059 |
| GROUP 4: OTDN Product 1 | Summary of 2-HPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -73.489 percentage of change | Standard Deviation 21.978 |
| GROUP 4: OTDN Product 1 | Summary of 2-HPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -72.078 percentage of change | Standard Deviation 24.0289 |
| GROUP 5: OTDN Product 2 | Summary of 2-HPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -59.835 percentage of change | Standard Deviation 42.1367 |
| GROUP 5: OTDN Product 2 | Summary of 2-HPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -61.684 percentage of change | Standard Deviation 33.6407 |
| GROUP 6: Tobacco Cessation | Summary of 2-HPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -75.225 percentage of change | Standard Deviation 16.1842 |
| GROUP 6: Tobacco Cessation | Summary of 2-HPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -71.565 percentage of change | Standard Deviation 20.1576 |
Secondary
Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Summary of 2-hydroxybutenyl-mercapturic acid (2-MHBMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.129 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Time frame: Baseline (Day -1), Day 5 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -0.104 ug/24 hour | Standard Deviation 1.9552 |
| GROUP 1: Continue Smoking | Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 5.126 ug/24 hour | Standard Deviation 3.6876 |
| GROUP 1: Continue Smoking | Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 5.230 ug/24 hour | Standard Deviation 4.3362 |
| GROUP 1: Continue Smoking | Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | 0.054 ug/24 hour | Standard Deviation 2.3432 |
| GROUP 1: Continue Smoking | Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 5.284 ug/24 hour | Standard Deviation 4.4769 |
| GROUP 2: OTDN Product 1 | Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 3.287 ug/24 hour | Standard Deviation 3.0863 |
| GROUP 2: OTDN Product 1 | Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -2.939 ug/24 hour | Standard Deviation 3.4047 |
| GROUP 2: OTDN Product 1 | Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 6.226 ug/24 hour | Standard Deviation 6.0371 |
| GROUP 2: OTDN Product 1 | Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -2.995 ug/24 hour | Standard Deviation 3.6985 |
| GROUP 2: OTDN Product 1 | Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 3.406 ug/24 hour | Standard Deviation 3.1052 |
| GROUP 3: OTDN Product 2 | Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 3.703 ug/24 hour | Standard Deviation 3.5055 |
| GROUP 3: OTDN Product 2 | Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -3.433 ug/24 hour | Standard Deviation 4.1785 |
| GROUP 3: OTDN Product 2 | Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -3.008 ug/24 hour | Standard Deviation 4.1064 |
| GROUP 3: OTDN Product 2 | Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 4.128 ug/24 hour | Standard Deviation 3.4363 |
| GROUP 3: OTDN Product 2 | Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 7.136 ug/24 hour | Standard Deviation 6.3804 |
| GROUP 4: OTDN Product 1 | Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 0.183 ug/24 hour | Standard Deviation 0.1539 |
| GROUP 4: OTDN Product 1 | Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 5.866 ug/24 hour | Standard Deviation 4.1432 |
| GROUP 4: OTDN Product 1 | Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 0.142 ug/24 hour | Standard Deviation 0.0714 |
| GROUP 4: OTDN Product 1 | Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -5.724 ug/24 hour | Standard Deviation 4.1297 |
| GROUP 4: OTDN Product 1 | Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -5.913 ug/24 hour | Standard Deviation 4.0535 |
| GROUP 5: OTDN Product 2 | Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -3.960 ug/24 hour | Standard Deviation 3.8836 |
| GROUP 5: OTDN Product 2 | Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 4.146 ug/24 hour | Standard Deviation 3.8962 |
| GROUP 5: OTDN Product 2 | Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -4.102 ug/24 hour | Standard Deviation 3.9316 |
| GROUP 5: OTDN Product 2 | Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 0.186 ug/24 hour | Standard Deviation 0.1141 |
| GROUP 5: OTDN Product 2 | Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 0.188 ug/24 hour | Standard Deviation 0.1097 |
| GROUP 6: Tobacco Cessation | Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 5.136 ug/24 hour | Standard Deviation 4.5388 |
| GROUP 6: Tobacco Cessation | Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -4.877 ug/24 hour | Standard Deviation 4.5654 |
| GROUP 6: Tobacco Cessation | Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 0.259 ug/24 hour | Standard Deviation 0.2148 |
| GROUP 6: Tobacco Cessation | Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -4.971 ug/24 hour | Standard Deviation 4.601 |
| GROUP 6: Tobacco Cessation | Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 0.216 ug/24 hour | Standard Deviation 0.1532 |
Comparison: Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [0.788, 1.382]Mixed Models Analysis
Comparison: Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [0.807, 1.4]Mixed Models Analysis
Comparison: Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [0.326, 0.886]Mixed Models Analysis
Comparison: Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)p-value: 0.001195% CI: [0.192, 0.76]Mixed Models Analysis
Comparison: Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)p-value: 0.000695% CI: [0.219, 0.79]Mixed Models Analysis
Comparison: Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [0.49, 1.06]Mixed Models Analysis
Comparison: Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [-2.472, -1.761]Mixed Models Analysis
Comparison: Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [-2.376, -1.656]Mixed Models Analysis
Comparison: Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [-1.958, -1.253]Mixed Models Analysis
Comparison: Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [-2.003, -1.282]Mixed Models Analysis
Comparison: Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [-1.922, -1.234]Mixed Models Analysis
Comparison: Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [-2.074, -1.378]Mixed Models Analysis
Comparison: Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: 0.157995% CI: [-1.054, 0.097]Mixed Models Analysis
Comparison: Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: 0.02695% CI: [-1.207, -0.048]Mixed Models Analysis
Comparison: Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: 0.048395% CI: [-1.158, -0.003]Mixed Models Analysis
Comparison: Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: 0.584295% CI: [-0.906, 0.249]Mixed Models Analysis
Comparison: Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: <0.000195% CI: [-3.856, -2.546]Mixed Models Analysis
Comparison: Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-3.779, -2.46]Mixed Models Analysis
Comparison: Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: <0.000195% CI: [-3.338, -2.043]Mixed Models Analysis
Comparison: Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-3.402, -2.09]Mixed Models Analysis
Comparison: Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: <0.000195% CI: [1.565, 2.803]Mixed Models Analysis
Comparison: Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: <0.000195% CI: [1.576, 2.828]Mixed Models Analysis
Comparison: Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: <0.000195% CI: [1.461, 2.704]Mixed Models Analysis
Comparison: Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: <0.000195% CI: [1.876, 3.126]Mixed Models Analysis
Comparison: Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 0.208595% CI: [-1.231, 0.154]Mixed Models Analysis
Comparison: Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 0.855795% CI: [-0.988, 0.41]Mixed Models Analysis
Comparison: Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 195% CI: [-0.713, 0.658]Mixed Models Analysis
Comparison: Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 195% CI: [-0.612, 0.78]Mixed Models Analysis
Secondary
Summary of 2-MHBMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Summary of 2-hydroxybutenyl-mercapturic acid (2-MHBMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.129 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %
Time frame: Day 5 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of 2-MHBMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | 97.272 percentage of change | Standard Deviation 337.255 |
| GROUP 1: Continue Smoking | Summary of 2-MHBMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | 89.466 percentage of change | Standard Deviation 362.5275 |
| GROUP 2: OTDN Product 1 | Summary of 2-MHBMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | 39.458 percentage of change | Standard Deviation 291.2398 |
| GROUP 2: OTDN Product 1 | Summary of 2-MHBMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | 28.617 percentage of change | Standard Deviation 287.5681 |
| GROUP 3: OTDN Product 2 | Summary of 2-MHBMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | 66.188 percentage of change | Standard Deviation 460.0304 |
| GROUP 3: OTDN Product 2 | Summary of 2-MHBMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -3.704 percentage of change | Standard Deviation 164.5239 |
| GROUP 4: OTDN Product 1 | Summary of 2-MHBMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -82.576 percentage of change | Standard Deviation 35.6633 |
| GROUP 4: OTDN Product 1 | Summary of 2-MHBMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -76.231 percentage of change | Standard Deviation 76.9824 |
| GROUP 5: OTDN Product 2 | Summary of 2-MHBMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -66.761 percentage of change | Standard Deviation 48.4733 |
| GROUP 5: OTDN Product 2 | Summary of 2-MHBMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -68.019 percentage of change | Standard Deviation 49.9841 |
| GROUP 6: Tobacco Cessation | Summary of 2-MHBMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -72.699 percentage of change | Standard Deviation 48.5745 |
| GROUP 6: Tobacco Cessation | Summary of 2-MHBMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -50.591 percentage of change | Standard Deviation 124.5982 |
Secondary
Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Summary of 2-Naphthol amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.10 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Time frame: Baseline (Day -1), Day 5 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 26.351 ug/24 hour | Standard Deviation 13.4453 |
| GROUP 1: Continue Smoking | Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -3.160 ug/24 hour | Standard Deviation 13.3625 |
| GROUP 1: Continue Smoking | Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -3.304 ug/24 hour | Standard Deviation 13.7567 |
| GROUP 1: Continue Smoking | Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 23.191 ug/24 hour | Standard Deviation 8.1002 |
| GROUP 1: Continue Smoking | Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 23.047 ug/24 hour | Standard Deviation 9.2844 |
| GROUP 2: OTDN Product 1 | Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 28.168 ug/24 hour | Standard Deviation 9.0786 |
| GROUP 2: OTDN Product 1 | Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 16.141 ug/24 hour | Standard Deviation 7.9059 |
| GROUP 2: OTDN Product 1 | Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -11.651 ug/24 hour | Standard Deviation 5.188 |
| GROUP 2: OTDN Product 1 | Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 16.228 ug/24 hour | Standard Deviation 8.2504 |
| GROUP 2: OTDN Product 1 | Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -12.027 ug/24 hour | Standard Deviation 6.3192 |
| GROUP 3: OTDN Product 2 | Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 15.475 ug/24 hour | Standard Deviation 7.182 |
| GROUP 3: OTDN Product 2 | Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 16.385 ug/24 hour | Standard Deviation 5.7688 |
| GROUP 3: OTDN Product 2 | Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 28.246 ug/24 hour | Standard Deviation 12.6762 |
| GROUP 3: OTDN Product 2 | Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -11.860 ug/24 hour | Standard Deviation 11.0884 |
| GROUP 3: OTDN Product 2 | Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -12.771 ug/24 hour | Standard Deviation 10.2647 |
| GROUP 4: OTDN Product 1 | Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 6.559 ug/24 hour | Standard Deviation 3.8649 |
| GROUP 4: OTDN Product 1 | Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -21.129 ug/24 hour | Standard Deviation 12.6944 |
| GROUP 4: OTDN Product 1 | Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 6.670 ug/24 hour | Standard Deviation 4.5266 |
| GROUP 4: OTDN Product 1 | Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -20.747 ug/24 hour | Standard Deviation 13.6498 |
| GROUP 4: OTDN Product 1 | Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 27.688 ug/24 hour | Standard Deviation 12.7029 |
| GROUP 5: OTDN Product 2 | Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -19.885 ug/24 hour | Standard Deviation 8.2403 |
| GROUP 5: OTDN Product 2 | Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 26.292 ug/24 hour | Standard Deviation 8.6468 |
| GROUP 5: OTDN Product 2 | Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 6.407 ug/24 hour | Standard Deviation 5.0282 |
| GROUP 5: OTDN Product 2 | Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 5.436 ug/24 hour | Standard Deviation 4.3673 |
| GROUP 5: OTDN Product 2 | Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -20.326 ug/24 hour | Standard Deviation 9.2076 |
| GROUP 6: Tobacco Cessation | Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -16.367 ug/24 hour | Standard Deviation 8.8314 |
| GROUP 6: Tobacco Cessation | Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 24.827 ug/24 hour | Standard Deviation 9.7689 |
| GROUP 6: Tobacco Cessation | Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 7.299 ug/24 hour | Standard Deviation 8.1699 |
| GROUP 6: Tobacco Cessation | Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 8.216 ug/24 hour | Standard Deviation 8.9779 |
| GROUP 6: Tobacco Cessation | Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -17.527 ug/24 hour | Standard Deviation 8.9468 |
Comparison: Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [2.964, 3.276]Mixed Models Analysis
Comparison: Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [2.953, 3.328]Mixed Models Analysis
Comparison: Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [2.511, 2.806]Mixed Models Analysis
Comparison: Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [2.458, 2.817]Mixed Models Analysis
Comparison: Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [2.604, 2.903]Mixed Models Analysis
Comparison: Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [2.471, 2.832]Mixed Models Analysis
Comparison: Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [1.517, 1.889]Mixed Models Analysis
Comparison: Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [1.41, 1.865]Mixed Models Analysis
Comparison: Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [1.472, 1.839]Mixed Models Analysis
Comparison: Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [1.259, 1.711]Mixed Models Analysis
Comparison: Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [1.532, 1.895]Mixed Models Analysis
Comparison: Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [1.397, 1.837]Mixed Models Analysis
Comparison: Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: 0.000395% CI: [-0.766, -0.158]Mixed Models Analysis
Comparison: Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: 0.001895% CI: [-0.867, -0.139]Mixed Models Analysis
Comparison: Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: 0.008995% CI: [-0.67, -0.062]Mixed Models Analysis
Comparison: Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: 0.002595% CI: [-0.851, -0.126]Mixed Models Analysis
Comparison: Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: <0.000195% CI: [-1.762, -1.072]Mixed Models Analysis
Comparison: Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-1.916, -1.091]Mixed Models Analysis
Comparison: Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: <0.000195% CI: [-1.804, -1.125]Mixed Models Analysis
Comparison: Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-2.065, -1.247]Mixed Models Analysis
Comparison: Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: <0.000195% CI: [0.617, 1.273]Mixed Models Analysis
Comparison: Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: <0.000195% CI: [0.628, 1.413]Mixed Models Analysis
Comparison: Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: <0.000195% CI: [0.712, 1.369]Mixed Models Analysis
Comparison: Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: <0.000195% CI: [0.644, 1.426]Mixed Models Analysis
Comparison: Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 195% CI: [-0.376, 0.355]Mixed Models Analysis
Comparison: Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 195% CI: [-0.417, 0.457]Mixed Models Analysis
Comparison: Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 0.999995% CI: [-0.418, 0.303]Mixed Models Analysis
Comparison: Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 0.966995% CI: [-0.566, 0.301]Mixed Models Analysis
Secondary
Summary of 2-Naphthol Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Summary of 2-Naphthol amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.10 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %
Time frame: Day 5 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of 2-Naphthol Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -2.871 percentage of change | Standard Deviation 48.4874 |
| GROUP 1: Continue Smoking | Summary of 2-Naphthol Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -3.848 percentage of change | Standard Deviation 33.7807 |
| GROUP 2: OTDN Product 1 | Summary of 2-Naphthol Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -42.250 percentage of change | Standard Deviation 17.7416 |
| GROUP 2: OTDN Product 1 | Summary of 2-Naphthol Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -42.498 percentage of change | Standard Deviation 16.2147 |
| GROUP 3: OTDN Product 2 | Summary of 2-Naphthol Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -35.217 percentage of change | Standard Deviation 25.6833 |
| GROUP 3: OTDN Product 2 | Summary of 2-Naphthol Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -40.149 percentage of change | Standard Deviation 24.8026 |
| GROUP 4: OTDN Product 1 | Summary of 2-Naphthol Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -72.375 percentage of change | Standard Deviation 20.2036 |
| GROUP 4: OTDN Product 1 | Summary of 2-Naphthol Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -70.911 percentage of change | Standard Deviation 23.8688 |
| GROUP 5: OTDN Product 2 | Summary of 2-Naphthol Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -74.880 percentage of change | Standard Deviation 16.3832 |
| GROUP 5: OTDN Product 2 | Summary of 2-Naphthol Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -77.080 percentage of change | Standard Deviation 18.579 |
| GROUP 6: Tobacco Cessation | Summary of 2-Naphthol Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -72.152 percentage of change | Standard Deviation 20.3724 |
| GROUP 6: Tobacco Cessation | Summary of 2-Naphthol Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -69.892 percentage of change | Standard Deviation 26.9968 |
Secondary
Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Summary of 2-OH-Fluorene (2-OHFLe) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.1 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Time frame: Baseline (Day -1), Day 5 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -0.478 ug/24 hour | Standard Deviation 5.8039 |
| GROUP 1: Continue Smoking | Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 5.535 ug/24 hour | Standard Deviation 5.5502 |
| GROUP 1: Continue Smoking | Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 6.013 ug/24 hour | Standard Deviation 5.5242 |
| GROUP 1: Continue Smoking | Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -0.668 ug/24 hour | Standard Deviation 5.3174 |
| GROUP 1: Continue Smoking | Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 5.471 ug/24 hour | Standard Deviation 4.9675 |
| GROUP 2: OTDN Product 1 | Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 6.002 ug/24 hour | Standard Deviation 14.2979 |
| GROUP 2: OTDN Product 1 | Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -0.452 ug/24 hour | Standard Deviation 15.421 |
| GROUP 2: OTDN Product 1 | Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 6.453 ug/24 hour | Standard Deviation 4.1583 |
| GROUP 2: OTDN Product 1 | Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -2.386 ug/24 hour | Standard Deviation 4.3279 |
| GROUP 2: OTDN Product 1 | Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 4.029 ug/24 hour | Standard Deviation 4.2137 |
| GROUP 3: OTDN Product 2 | Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 5.006 ug/24 hour | Standard Deviation 10.0199 |
| GROUP 3: OTDN Product 2 | Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -0.023 ug/24 hour | Standard Deviation 9.1944 |
| GROUP 3: OTDN Product 2 | Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -1.728 ug/24 hour | Standard Deviation 3.6338 |
| GROUP 3: OTDN Product 2 | Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 3.219 ug/24 hour | Standard Deviation 3.6982 |
| GROUP 3: OTDN Product 2 | Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 4.947 ug/24 hour | Standard Deviation 4.271 |
| GROUP 4: OTDN Product 1 | Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 2.238 ug/24 hour | Standard Deviation 2.5664 |
| GROUP 4: OTDN Product 1 | Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 5.424 ug/24 hour | Standard Deviation 4.1109 |
| GROUP 4: OTDN Product 1 | Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 2.857 ug/24 hour | Standard Deviation 2.6235 |
| GROUP 4: OTDN Product 1 | Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -2.567 ug/24 hour | Standard Deviation 4.2155 |
| GROUP 4: OTDN Product 1 | Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -3.176 ug/24 hour | Standard Deviation 4.933 |
| GROUP 5: OTDN Product 2 | Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -5.222 ug/24 hour | Standard Deviation 16.0117 |
| GROUP 5: OTDN Product 2 | Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 8.101 ug/24 hour | Standard Deviation 16.9678 |
| GROUP 5: OTDN Product 2 | Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -5.989 ug/24 hour | Standard Deviation 15.2327 |
| GROUP 5: OTDN Product 2 | Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 2.879 ug/24 hour | Standard Deviation 4.0524 |
| GROUP 5: OTDN Product 2 | Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 2.493 ug/24 hour | Standard Deviation 3.5417 |
| GROUP 6: Tobacco Cessation | Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 4.852 ug/24 hour | Standard Deviation 2.3571 |
| GROUP 6: Tobacco Cessation | Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -2.752 ug/24 hour | Standard Deviation 2.061 |
| GROUP 6: Tobacco Cessation | Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 2.101 ug/24 hour | Standard Deviation 1.2935 |
| GROUP 6: Tobacco Cessation | Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -2.710 ug/24 hour | Standard Deviation 2.7968 |
| GROUP 6: Tobacco Cessation | Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 2.046 ug/24 hour | Standard Deviation 2.1506 |
Comparison: Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [0.679, 1.484]Mixed Models Analysis
Comparison: Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [0.902, 1.716]Mixed Models Analysis
Comparison: Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [0.615, 1.377]Mixed Models Analysis
Comparison: Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)p-value: 0.000395% CI: [0.339, 1.116]Mixed Models Analysis
Comparison: Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [0.593, 1.381]Mixed Models Analysis
Comparison: Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [0.475, 1.254]Mixed Models Analysis
Comparison: Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)p-value: 0.076895% CI: [-0.047, 0.92]Mixed Models Analysis
Comparison: Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)p-value: 0.715595% CI: [-0.4, 0.583]Mixed Models Analysis
Comparison: Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)p-value: 0.328295% CI: [-0.239, 0.713]Mixed Models Analysis
Comparison: Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)p-value: 0.357895% CI: [-0.722, 0.262]Mixed Models Analysis
Comparison: Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)p-value: 0.163895% CI: [-0.138, 0.814]Mixed Models Analysis
Comparison: Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)p-value: 0.838495% CI: [-0.533, 0.433]Mixed Models Analysis
Comparison: Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: 195% CI: [-0.869, 0.698]Mixed Models Analysis
Comparison: Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: 0.280895% CI: [-1.377, 0.214]Mixed Models Analysis
Comparison: Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: 195% CI: [-0.887, 0.698]Mixed Models Analysis
Comparison: Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: 0.601895% CI: [-1.237, 0.349]Mixed Models Analysis
Comparison: Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: 0.293595% CI: [-1.536, 0.246]Mixed Models Analysis
Comparison: Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: 0.002395% CI: [-2.12, -0.315]Mixed Models Analysis
Comparison: Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: 0.066995% CI: [-1.723, 0.035]Mixed Models Analysis
Comparison: Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-2.438, -0.64]Mixed Models Analysis
Comparison: Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 0.21295% CI: [-0.192, 1.509]Mixed Models Analysis
Comparison: Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 0.099395% CI: [-0.087, 1.642]Mixed Models Analysis
Comparison: Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 0.234795% CI: [-0.211, 1.509]Mixed Models Analysis
Comparison: Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 0.03295% CI: [0.052, 1.778]Mixed Models Analysis
Comparison: Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 195% CI: [-0.849, 1.047]Mixed Models Analysis
Comparison: Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 0.999995% CI: [-0.82, 1.103]Mixed Models Analysis
Comparison: Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 195% CI: [-1.038, 0.837]Mixed Models Analysis
Comparison: Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 0.999595% CI: [-1.139, 0.779]Mixed Models Analysis
Secondary
Summary of 2-OHFLe Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Summary of 2-OH-Fluorene (2-OHFLe) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.1 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %
Time frame: Day 5 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of 2-OHFLe Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | 12.958 percentage of change | Standard Deviation 105.7554 |
| GROUP 1: Continue Smoking | Summary of 2-OHFLe Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | 15.496 percentage of change | Standard Deviation 81.6064 |
| GROUP 2: OTDN Product 1 | Summary of 2-OHFLe Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | 503.991 percentage of change | Standard Deviation 3454.7322 |
| GROUP 2: OTDN Product 1 | Summary of 2-OHFLe Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | 5043.768 percentage of change | Standard Deviation 32905.9569 |
| GROUP 3: OTDN Product 2 | Summary of 2-OHFLe Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | 272.425 percentage of change | Standard Deviation 1374.3325 |
| GROUP 3: OTDN Product 2 | Summary of 2-OHFLe Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | 178.037 percentage of change | Standard Deviation 1045.5731 |
| GROUP 4: OTDN Product 1 | Summary of 2-OHFLe Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -45.034 percentage of change | Standard Deviation 38.393 |
| GROUP 4: OTDN Product 1 | Summary of 2-OHFLe Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -48.971 percentage of change | Standard Deviation 54.0298 |
| GROUP 5: OTDN Product 2 | Summary of 2-OHFLe Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -37.094 percentage of change | Standard Deviation 118.0482 |
| GROUP 5: OTDN Product 2 | Summary of 2-OHFLe Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -63.094 percentage of change | Standard Deviation 41.9257 |
| GROUP 6: Tobacco Cessation | Summary of 2-OHFLe Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -54.026 percentage of change | Standard Deviation 57.965 |
| GROUP 6: Tobacco Cessation | Summary of 2-OHFLe Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -52.455 percentage of change | Standard Deviation 32.2698 |
Secondary
Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Summary of 3-hydroxy-1-methylpropylmercapturic acid (3-HMPMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (5 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Time frame: Baseline (Day -1), Day 5 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -42.021 ug/24 hour | Standard Deviation 124.9105 |
| GROUP 1: Continue Smoking | Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 508.316 ug/24 hour | Standard Deviation 206.5741 |
| GROUP 1: Continue Smoking | Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 550.337 ug/24 hour | Standard Deviation 205.3039 |
| GROUP 1: Continue Smoking | Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -29.196 ug/24 hour | Standard Deviation 131.9289 |
| GROUP 1: Continue Smoking | Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 521.141 ug/24 hour | Standard Deviation 217.2385 |
| GROUP 2: OTDN Product 1 | Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 354.525 ug/24 hour | Standard Deviation 133.4293 |
| GROUP 2: OTDN Product 1 | Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -211.682 ug/24 hour | Standard Deviation 131.0495 |
| GROUP 2: OTDN Product 1 | Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 566.207 ug/24 hour | Standard Deviation 212.2527 |
| GROUP 2: OTDN Product 1 | Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -193.629 ug/24 hour | Standard Deviation 132.1995 |
| GROUP 2: OTDN Product 1 | Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 368.736 ug/24 hour | Standard Deviation 160.2715 |
| GROUP 3: OTDN Product 2 | Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 404.976 ug/24 hour | Standard Deviation 183.1641 |
| GROUP 3: OTDN Product 2 | Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -215.275 ug/24 hour | Standard Deviation 189.0406 |
| GROUP 3: OTDN Product 2 | Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -236.535 ug/24 hour | Standard Deviation 185.1107 |
| GROUP 3: OTDN Product 2 | Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 383.715 ug/24 hour | Standard Deviation 158.6928 |
| GROUP 3: OTDN Product 2 | Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 620.251 ug/24 hour | Standard Deviation 282.7648 |
| GROUP 4: OTDN Product 1 | Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 150.400 ug/24 hour | Standard Deviation 63.8041 |
| GROUP 4: OTDN Product 1 | Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 606.423 ug/24 hour | Standard Deviation 388.1189 |
| GROUP 4: OTDN Product 1 | Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 167.136 ug/24 hour | Standard Deviation 103.8973 |
| GROUP 4: OTDN Product 1 | Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -439.287 ug/24 hour | Standard Deviation 355.2849 |
| GROUP 4: OTDN Product 1 | Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -455.759 ug/24 hour | Standard Deviation 392.8206 |
| GROUP 5: OTDN Product 2 | Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -424.984 ug/24 hour | Standard Deviation 215.2851 |
| GROUP 5: OTDN Product 2 | Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 569.736 ug/24 hour | Standard Deviation 236.5974 |
| GROUP 5: OTDN Product 2 | Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -414.706 ug/24 hour | Standard Deviation 229.5738 |
| GROUP 5: OTDN Product 2 | Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 144.751 ug/24 hour | Standard Deviation 65.9291 |
| GROUP 5: OTDN Product 2 | Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 157.595 ug/24 hour | Standard Deviation 79.8494 |
| GROUP 6: Tobacco Cessation | Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 563.298 ug/24 hour | Standard Deviation 237.6972 |
| GROUP 6: Tobacco Cessation | Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -421.414 ug/24 hour | Standard Deviation 213.6181 |
| GROUP 6: Tobacco Cessation | Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 141.885 ug/24 hour | Standard Deviation 80.2953 |
| GROUP 6: Tobacco Cessation | Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -411.417 ug/24 hour | Standard Deviation 194.8371 |
| GROUP 6: Tobacco Cessation | Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 155.132 ug/24 hour | Standard Deviation 75.3979 |
Comparison: Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [6.062, 6.292]Mixed Models Analysis
Comparison: Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [6.082, 6.312]Mixed Models Analysis
Comparison: Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [5.69, 5.906]Mixed Models Analysis
Comparison: Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [5.71, 5.93]Mixed Models Analysis
Comparison: Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [5.753, 5.974]Mixed Models Analysis
Comparison: Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [5.706, 5.927]Mixed Models Analysis
Comparison: Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [4.809, 5.084]Mixed Models Analysis
Comparison: Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [4.774, 5.052]Mixed Models Analysis
Comparison: Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [4.727, 4.998]Mixed Models Analysis
Comparison: Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [4.799, 5.076]Mixed Models Analysis
Comparison: Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [4.693, 4.959]Mixed Models Analysis
Comparison: Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [4.767, 5.037]Mixed Models Analysis
Comparison: Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: <0.000195% CI: [-0.602, -0.156]Mixed Models Analysis
Comparison: Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-0.601, -0.152]Mixed Models Analysis
Comparison: Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: 0.001495% CI: [-0.537, -0.09]Mixed Models Analysis
Comparison: Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-0.604, -0.157]Mixed Models Analysis
Comparison: Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: <0.000195% CI: [-1.484, -0.977]Mixed Models Analysis
Comparison: Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-1.539, -1.029]Mixed Models Analysis
Comparison: Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: <0.000195% CI: [-1.564, -1.065]Mixed Models Analysis
Comparison: Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-1.512, -1.006]Mixed Models Analysis
Comparison: Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: <0.000195% CI: [0.732, 1.211]Mixed Models Analysis
Comparison: Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: <0.000195% CI: [0.676, 1.161]Mixed Models Analysis
Comparison: Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: <0.000195% CI: [0.797, 1.278]Mixed Models Analysis
Comparison: Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: <0.000195% CI: [0.672, 1.156]Mixed Models Analysis
Comparison: Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 0.793995% CI: [-0.147, 0.388]Mixed Models Analysis
Comparison: Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 195% CI: [-0.26, 0.281]Mixed Models Analysis
Comparison: Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 195% CI: [-0.228, 0.301]Mixed Models Analysis
Comparison: Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 195% CI: [-0.233, 0.305]Mixed Models Analysis
Secondary
Summary of 3-HMPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Summary of 3-hydroxy-1-methylpropylmercapturic acid (3-HMPMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (5 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %
Time frame: Day 5 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of 3-HMPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -5.743 percentage of change | Standard Deviation 22.696 |
| GROUP 1: Continue Smoking | Summary of 3-HMPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -3.562 percentage of change | Standard Deviation 25.6505 |
| GROUP 2: OTDN Product 1 | Summary of 3-HMPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -35.546 percentage of change | Standard Deviation 13.9889 |
| GROUP 2: OTDN Product 1 | Summary of 3-HMPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -33.002 percentage of change | Standard Deviation 17.292 |
| GROUP 3: OTDN Product 2 | Summary of 3-HMPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -32.157 percentage of change | Standard Deviation 17.5366 |
| GROUP 3: OTDN Product 2 | Summary of 3-HMPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -35.002 percentage of change | Standard Deviation 15.4967 |
| GROUP 4: OTDN Product 1 | Summary of 3-HMPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -68.831 percentage of change | Standard Deviation 18.5627 |
| GROUP 4: OTDN Product 1 | Summary of 3-HMPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -68.732 percentage of change | Standard Deviation 19.6288 |
| GROUP 5: OTDN Product 2 | Summary of 3-HMPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -72.980 percentage of change | Standard Deviation 12.2613 |
| GROUP 5: OTDN Product 2 | Summary of 3-HMPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -70.424 percentage of change | Standard Deviation 15.9381 |
| GROUP 6: Tobacco Cessation | Summary of 3-HMPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -73.991 percentage of change | Standard Deviation 12.7785 |
| GROUP 6: Tobacco Cessation | Summary of 3-HMPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -72.466 percentage of change | Standard Deviation 9.0818 |
Secondary
Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Summary of 3-hydroxypropylmercapturic acid (3-HPMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (25 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Time frame: Baseline (Day -1), Day 5 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -65.969 ug/24 hour | Standard Deviation 393.3398 |
| GROUP 1: Continue Smoking | Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 1677.258 ug/24 hour | Standard Deviation 665.1729 |
| GROUP 1: Continue Smoking | Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 1743.226 ug/24 hour | Standard Deviation 668.1382 |
| GROUP 1: Continue Smoking | Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -84.472 ug/24 hour | Standard Deviation 405.0119 |
| GROUP 1: Continue Smoking | Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 1658.754 ug/24 hour | Standard Deviation 609.9999 |
| GROUP 2: OTDN Product 1 | Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 1043.324 ug/24 hour | Standard Deviation 409.5555 |
| GROUP 2: OTDN Product 1 | Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -723.442 ug/24 hour | Standard Deviation 409.5358 |
| GROUP 2: OTDN Product 1 | Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 1766.765 ug/24 hour | Standard Deviation 615.6747 |
| GROUP 2: OTDN Product 1 | Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -715.263 ug/24 hour | Standard Deviation 368.439 |
| GROUP 2: OTDN Product 1 | Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 1047.861 ug/24 hour | Standard Deviation 369.5717 |
| GROUP 3: OTDN Product 2 | Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 1201.051 ug/24 hour | Standard Deviation 542.2406 |
| GROUP 3: OTDN Product 2 | Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -785.340 ug/24 hour | Standard Deviation 505.9671 |
| GROUP 3: OTDN Product 2 | Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -833.680 ug/24 hour | Standard Deviation 621.2865 |
| GROUP 3: OTDN Product 2 | Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 1152.712 ug/24 hour | Standard Deviation 512.4255 |
| GROUP 3: OTDN Product 2 | Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 1986.391 ug/24 hour | Standard Deviation 853.8727 |
| GROUP 4: OTDN Product 1 | Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 384.725 ug/24 hour | Standard Deviation 186.4687 |
| GROUP 4: OTDN Product 1 | Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 1865.738 ug/24 hour | Standard Deviation 901.8706 |
| GROUP 4: OTDN Product 1 | Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 433.971 ug/24 hour | Standard Deviation 295.7202 |
| GROUP 4: OTDN Product 1 | Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -1431.767 ug/24 hour | Standard Deviation 841.9879 |
| GROUP 4: OTDN Product 1 | Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -1485.874 ug/24 hour | Standard Deviation 894.8234 |
| GROUP 5: OTDN Product 2 | Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -1351.790 ug/24 hour | Standard Deviation 761.5792 |
| GROUP 5: OTDN Product 2 | Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 1811.893 ug/24 hour | Standard Deviation 878.2589 |
| GROUP 5: OTDN Product 2 | Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -1442.549 ug/24 hour | Standard Deviation 862.2948 |
| GROUP 5: OTDN Product 2 | Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 460.103 ug/24 hour | Standard Deviation 391.5957 |
| GROUP 5: OTDN Product 2 | Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 414.764 ug/24 hour | Standard Deviation 193.2655 |
| GROUP 6: Tobacco Cessation | Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 1922.765 ug/24 hour | Standard Deviation 697.3324 |
| GROUP 6: Tobacco Cessation | Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -1450.942 ug/24 hour | Standard Deviation 571.816 |
| GROUP 6: Tobacco Cessation | Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 471.823 ug/24 hour | Standard Deviation 210.0711 |
| GROUP 6: Tobacco Cessation | Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -1455.899 ug/24 hour | Standard Deviation 646.1344 |
| GROUP 6: Tobacco Cessation | Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 465.606 ug/24 hour | Standard Deviation 181.142 |
Comparison: Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [7.25, 7.485]Mixed Models Analysis
Comparison: Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [7.251, 7.485]Mixed Models Analysis
Comparison: Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [6.773, 6.994]Mixed Models Analysis
Comparison: Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [6.78, 7.004]Mixed Models Analysis
Comparison: Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [6.829, 7.054]Mixed Models Analysis
Comparison: Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [6.784, 7.008]Mixed Models Analysis
Comparison: Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [5.739, 6.019]Mixed Models Analysis
Comparison: Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [5.662, 5.946]Mixed Models Analysis
Comparison: Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [5.778, 6.054]Mixed Models Analysis
Comparison: Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [5.775, 6.058]Mixed Models Analysis
Comparison: Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [5.881, 6.153]Mixed Models Analysis
Comparison: Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [5.874, 6.149]Mixed Models Analysis
Comparison: Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: <0.000195% CI: [-0.711, -0.257]Mixed Models Analysis
Comparison: Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-0.705, -0.248]Mixed Models Analysis
Comparison: Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: <0.000195% CI: [-0.654, -0.198]Mixed Models Analysis
Comparison: Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-0.701, -0.244]Mixed Models Analysis
Comparison: Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: <0.000195% CI: [-1.747, -1.23]Mixed Models Analysis
Comparison: Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-1.825, -1.304]Mixed Models Analysis
Comparison: Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: <0.000195% CI: [-1.706, -1.197]Mixed Models Analysis
Comparison: Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-1.71, -1.193]Mixed Models Analysis
Comparison: Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: <0.000195% CI: [0.622, 1.11]Mixed Models Analysis
Comparison: Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: <0.000195% CI: [0.633, 1.128]Mixed Models Analysis
Comparison: Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: <0.000195% CI: [0.68, 1.169]Mixed Models Analysis
Comparison: Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: <0.000195% CI: [0.638, 1.131]Mixed Models Analysis
Comparison: Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 0.6895% CI: [-0.411, 0.134]Mixed Models Analysis
Comparison: Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 0.237195% CI: [-0.483, 0.068]Mixed Models Analysis
Comparison: Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 0.913395% CI: [-0.371, 0.169]Mixed Models Analysis
Comparison: Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 0.943295% CI: [-0.37, 0.18]Mixed Models Analysis
Secondary
Summary of 3-HPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Summary of 3-hydroxypropylmercapturic acid (3-HPMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (25 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %
Time frame: Day 5 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of 3-HPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -1.420 percentage of change | Standard Deviation 24.6382 |
| GROUP 1: Continue Smoking | Summary of 3-HPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -1.110 percentage of change | Standard Deviation 25.6542 |
| GROUP 2: OTDN Product 1 | Summary of 3-HPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -39.382 percentage of change | Standard Deviation 16.8251 |
| GROUP 2: OTDN Product 1 | Summary of 3-HPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -39.328 percentage of change | Standard Deviation 10.6349 |
| GROUP 3: OTDN Product 2 | Summary of 3-HPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -37.881 percentage of change | Standard Deviation 14.6021 |
| GROUP 3: OTDN Product 2 | Summary of 3-HPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -39.461 percentage of change | Standard Deviation 16.1768 |
| GROUP 4: OTDN Product 1 | Summary of 3-HPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -75.303 percentage of change | Standard Deviation 13.2868 |
| GROUP 4: OTDN Product 1 | Summary of 3-HPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -76.922 percentage of change | Standard Deviation 13.007 |
| GROUP 5: OTDN Product 2 | Summary of 3-HPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -74.412 percentage of change | Standard Deviation 14.4248 |
| GROUP 5: OTDN Product 2 | Summary of 3-HPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -74.522 percentage of change | Standard Deviation 13.5851 |
| GROUP 6: Tobacco Cessation | Summary of 3-HPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -74.897 percentage of change | Standard Deviation 7.6082 |
| GROUP 6: Tobacco Cessation | Summary of 3-HPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -74.238 percentage of change | Standard Deviation 9.0407 |
Secondary
Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population)
Summary of 4-aminobiphenyl (4-ABP) amount excreted (ng/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (1.5 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Time frame: Baseline (Day -1), Day 5 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -2.095 ng/24 hour | Standard Deviation 5.7359 |
| GROUP 1: Continue Smoking | Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 21.449 ng/24 hour | Standard Deviation 8.2875 |
| GROUP 1: Continue Smoking | Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 23.544 ng/24 hour | Standard Deviation 7.4856 |
| GROUP 1: Continue Smoking | Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -1.845 ng/24 hour | Standard Deviation 6.5921 |
| GROUP 1: Continue Smoking | Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 21.700 ng/24 hour | Standard Deviation 8.5794 |
| GROUP 2: OTDN Product 1 | Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 15.684 ng/24 hour | Standard Deviation 9.7048 |
| GROUP 2: OTDN Product 1 | Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -11.782 ng/24 hour | Standard Deviation 10.5603 |
| GROUP 2: OTDN Product 1 | Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 27.465 ng/24 hour | Standard Deviation 11.133 |
| GROUP 2: OTDN Product 1 | Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -13.155 ng/24 hour | Standard Deviation 7.7979 |
| GROUP 2: OTDN Product 1 | Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 14.315 ng/24 hour | Standard Deviation 4.8816 |
| GROUP 3: OTDN Product 2 | Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 16.673 ng/24 hour | Standard Deviation 6.8533 |
| GROUP 3: OTDN Product 2 | Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -9.846 ng/24 hour | Standard Deviation 7.3757 |
| GROUP 3: OTDN Product 2 | Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -10.951 ng/24 hour | Standard Deviation 7.0304 |
| GROUP 3: OTDN Product 2 | Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 15.567 ng/24 hour | Standard Deviation 6.1982 |
| GROUP 3: OTDN Product 2 | Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 26.519 ng/24 hour | Standard Deviation 9.2829 |
| GROUP 4: OTDN Product 1 | Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 3.484 ng/24 hour | Standard Deviation 1.7674 |
| GROUP 4: OTDN Product 1 | Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 25.848 ng/24 hour | Standard Deviation 11.3291 |
| GROUP 4: OTDN Product 1 | Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 3.785 ng/24 hour | Standard Deviation 1.8918 |
| GROUP 4: OTDN Product 1 | Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -22.063 ng/24 hour | Standard Deviation 11.0772 |
| GROUP 4: OTDN Product 1 | Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -22.223 ng/24 hour | Standard Deviation 11.3969 |
| GROUP 5: OTDN Product 2 | Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -21.140 ng/24 hour | Standard Deviation 7.9655 |
| GROUP 5: OTDN Product 2 | Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 24.833 ng/24 hour | Standard Deviation 8.8138 |
| GROUP 5: OTDN Product 2 | Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -21.704 ng/24 hour | Standard Deviation 8.2641 |
| GROUP 5: OTDN Product 2 | Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 3.692 ng/24 hour | Standard Deviation 1.5741 |
| GROUP 5: OTDN Product 2 | Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 3.422 ng/24 hour | Standard Deviation 1.2121 |
| GROUP 6: Tobacco Cessation | Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 26.229 ng/24 hour | Standard Deviation 7.3619 |
| GROUP 6: Tobacco Cessation | Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -22.403 ng/24 hour | Standard Deviation 7.0583 |
| GROUP 6: Tobacco Cessation | Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 3.826 ng/24 hour | Standard Deviation 2.0856 |
| GROUP 6: Tobacco Cessation | Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -22.419 ng/24 hour | Standard Deviation 7.2026 |
| GROUP 6: Tobacco Cessation | Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 3.577 ng/24 hour | Standard Deviation 1.2299 |
Comparison: Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [2.901, 3.154]Mixed Models Analysis
Comparison: Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [2.927, 3.141]Mixed Models Analysis
Comparison: Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [2.483, 2.722]Mixed Models Analysis
Comparison: Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [2.465, 2.67]Mixed Models Analysis
Comparison: Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [2.595, 2.838]Mixed Models Analysis
Comparison: Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [2.541, 2.746]Mixed Models Analysis
Comparison: Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [1.083, 1.386]Mixed Models Analysis
Comparison: Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [1.045, 1.304]Mixed Models Analysis
Comparison: Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [1.07, 1.368]Mixed Models Analysis
Comparison: Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [1.046, 1.306]Mixed Models Analysis
Comparison: Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [1.029, 1.322]Mixed Models Analysis
Comparison: Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [1.049, 1.3]Mixed Models Analysis
Comparison: Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: <0.000195% CI: [-0.669, -0.181]Mixed Models Analysis
Comparison: Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-0.677, -0.256]Mixed Models Analysis
Comparison: Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: 0.005295% CI: [-0.556, -0.066]Mixed Models Analysis
Comparison: Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-0.6, -0.182]Mixed Models Analysis
Comparison: Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: <0.000195% CI: [-2.07, -1.516]Mixed Models Analysis
Comparison: Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-2.098, -1.621]Mixed Models Analysis
Comparison: Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: <0.000195% CI: [-2.082, -1.535]Mixed Models Analysis
Comparison: Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-2.096, -1.621]Mixed Models Analysis
Comparison: Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: <0.000195% CI: [1.166, 1.688]Mixed Models Analysis
Comparison: Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: <0.000195% CI: [1.166, 1.62]Mixed Models Analysis
Comparison: Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: <0.000195% CI: [1.278, 1.803]Mixed Models Analysis
Comparison: Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: <0.000195% CI: [1.243, 1.695]Mixed Models Analysis
Comparison: Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 0.998795% CI: [-0.233, 0.351]Mixed Models Analysis
Comparison: Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 195% CI: [-0.253, 0.254]Mixed Models Analysis
Comparison: Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 0.999995% CI: [-0.246, 0.332]Mixed Models Analysis
Comparison: Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 195% CI: [-0.251, 0.254]Mixed Models Analysis
Secondary
Summary of 4-ABP Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Summary of 4-aminobiphenyl (4-ABP) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (1.5 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %
Time frame: Day 5 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of 4-ABP Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -7.609 percentage of change | Standard Deviation 26.3983 |
| GROUP 1: Continue Smoking | Summary of 4-ABP Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -5.403 percentage of change | Standard Deviation 40.5212 |
| GROUP 2: OTDN Product 1 | Summary of 4-ABP Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -40.399 percentage of change | Standard Deviation 31.853 |
| GROUP 2: OTDN Product 1 | Summary of 4-ABP Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -44.837 percentage of change | Standard Deviation 13.1354 |
| GROUP 3: OTDN Product 2 | Summary of 4-ABP Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -34.438 percentage of change | Standard Deviation 20.0016 |
| GROUP 3: OTDN Product 2 | Summary of 4-ABP Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -38.874 percentage of change | Standard Deviation 19.1985 |
| GROUP 4: OTDN Product 1 | Summary of 4-ABP Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -83.203 percentage of change | Standard Deviation 9.1553 |
| GROUP 4: OTDN Product 1 | Summary of 4-ABP Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -84.141 percentage of change | Standard Deviation 9.223 |
| GROUP 5: OTDN Product 2 | Summary of 4-ABP Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -84.690 percentage of change | Standard Deviation 6.4161 |
| GROUP 5: OTDN Product 2 | Summary of 4-ABP Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -85.226 percentage of change | Standard Deviation 5.6972 |
| GROUP 6: Tobacco Cessation | Summary of 4-ABP Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -84.782 percentage of change | Standard Deviation 8.1574 |
| GROUP 6: Tobacco Cessation | Summary of 4-ABP Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -85.492 percentage of change | Standard Deviation 6.0029 |
Secondary
Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Summary of N-acetyl-S-(2-carbamoylethyl)-l-cysteine (AAMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (10 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Time frame: Baseline (Day -1), Day 5 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 205.752 ug/24 hour | Standard Deviation 69.9796 |
| GROUP 1: Continue Smoking | Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -9.451 ug/24 hour | Standard Deviation 47.6276 |
| GROUP 1: Continue Smoking | Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | 3.794 ug/24 hour | Standard Deviation 61.0286 |
| GROUP 1: Continue Smoking | Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 196.301 ug/24 hour | Standard Deviation 78.9983 |
| GROUP 1: Continue Smoking | Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 209.546 ug/24 hour | Standard Deviation 92.1646 |
| GROUP 2: OTDN Product 1 | Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 213.840 ug/24 hour | Standard Deviation 84.3383 |
| GROUP 2: OTDN Product 1 | Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 170.626 ug/24 hour | Standard Deviation 87.7149 |
| GROUP 2: OTDN Product 1 | Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -53.542 ug/24 hour | Standard Deviation 45.4159 |
| GROUP 2: OTDN Product 1 | Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 162.085 ug/24 hour | Standard Deviation 77.9669 |
| GROUP 2: OTDN Product 1 | Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -43.214 ug/24 hour | Standard Deviation 47.8198 |
| GROUP 3: OTDN Product 2 | Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 185.991 ug/24 hour | Standard Deviation 85.8673 |
| GROUP 3: OTDN Product 2 | Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 194.963 ug/24 hour | Standard Deviation 78.8241 |
| GROUP 3: OTDN Product 2 | Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -39.416 ug/24 hour | Standard Deviation 74.9528 |
| GROUP 3: OTDN Product 2 | Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -48.387 ug/24 hour | Standard Deviation 69.3531 |
| GROUP 3: OTDN Product 2 | Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 234.379 ug/24 hour | Standard Deviation 110.9685 |
| GROUP 4: OTDN Product 1 | Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 99.589 ug/24 hour | Standard Deviation 70.9683 |
| GROUP 4: OTDN Product 1 | Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 85.598 ug/24 hour | Standard Deviation 53.8351 |
| GROUP 4: OTDN Product 1 | Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -96.049 ug/24 hour | Standard Deviation 49.6356 |
| GROUP 4: OTDN Product 1 | Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 179.355 ug/24 hour | Standard Deviation 60.6867 |
| GROUP 4: OTDN Product 1 | Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -79.766 ug/24 hour | Standard Deviation 73.7312 |
| GROUP 5: OTDN Product 2 | Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -112.116 ug/24 hour | Standard Deviation 61.2701 |
| GROUP 5: OTDN Product 2 | Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 203.156 ug/24 hour | Standard Deviation 69.9106 |
| GROUP 5: OTDN Product 2 | Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 84.941 ug/24 hour | Standard Deviation 36.0825 |
| GROUP 5: OTDN Product 2 | Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 91.040 ug/24 hour | Standard Deviation 46.5105 |
| GROUP 5: OTDN Product 2 | Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -122.821 ug/24 hour | Standard Deviation 56.8629 |
| GROUP 6: Tobacco Cessation | Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -96.887 ug/24 hour | Standard Deviation 57.5065 |
| GROUP 6: Tobacco Cessation | Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 212.299 ug/24 hour | Standard Deviation 72.6566 |
| GROUP 6: Tobacco Cessation | Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 103.427 ug/24 hour | Standard Deviation 61.1171 |
| GROUP 6: Tobacco Cessation | Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -108.872 ug/24 hour | Standard Deviation 60.5423 |
| GROUP 6: Tobacco Cessation | Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 112.082 ug/24 hour | Standard Deviation 48.2731 |
Comparison: Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [5.155, 5.373]Mixed Models Analysis
Comparison: Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [5.106, 5.302]Mixed Models Analysis
Comparison: Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [4.902, 5.108]Mixed Models Analysis
Comparison: Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [4.864, 5.051]Mixed Models Analysis
Comparison: Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [5.009, 5.219]Mixed Models Analysis
Comparison: Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [4.958, 5.146]Mixed Models Analysis
Comparison: Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [4.407, 4.671]Mixed Models Analysis
Comparison: Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [4.295, 4.534]Mixed Models Analysis
Comparison: Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [4.302, 4.56]Mixed Models Analysis
Comparison: Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [4.243, 4.48]Mixed Models Analysis
Comparison: Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [4.359, 4.612]Mixed Models Analysis
Comparison: Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [4.473, 4.703]Mixed Models Analysis
Comparison: Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: 0.007395% CI: [-0.469, -0.049]Mixed Models Analysis
Comparison: Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: 0.004195% CI: [-0.438, -0.055]Mixed Models Analysis
Comparison: Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: 0.30895% CI: [-0.361, 0.061]Mixed Models Analysis
Comparison: Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: 0.198295% CI: [-0.343, 0.039]Mixed Models Analysis
Comparison: Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: <0.000195% CI: [-0.965, -0.486]Mixed Models Analysis
Comparison: Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-1.008, -0.571]Mixed Models Analysis
Comparison: Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: <0.000195% CI: [-1.069, -0.597]Mixed Models Analysis
Comparison: Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-1.059, -0.627]Mixed Models Analysis
Comparison: Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: <0.000195% CI: [0.294, 0.745]Mixed Models Analysis
Comparison: Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: <0.000195% CI: [0.163, 0.577]Mixed Models Analysis
Comparison: Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: <0.000195% CI: [0.402, 0.855]Mixed Models Analysis
Comparison: Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: <0.000195% CI: [0.257, 0.67]Mixed Models Analysis
Comparison: Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 0.998495% CI: [-0.2, 0.306]Mixed Models Analysis
Comparison: Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 0.249195% CI: [-0.405, 0.058]Mixed Models Analysis
Comparison: Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 0.997795% CI: [-0.304, 0.195]Mixed Models Analysis
Comparison: Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 0.055495% CI: [-0.456, 0.003]Mixed Models Analysis
Secondary
Summary of AAMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Summary of N-acetyl-S-(2-carbamoylethyl)-l-cysteine (AAMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (10 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %
Time frame: Day 5 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of AAMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | 2.922 percentage of change | Standard Deviation 27.1486 |
| GROUP 1: Continue Smoking | Summary of AAMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -3.571 percentage of change | Standard Deviation 22.7243 |
| GROUP 2: OTDN Product 1 | Summary of AAMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -20.973 percentage of change | Standard Deviation 22.5861 |
| GROUP 2: OTDN Product 1 | Summary of AAMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -25.039 percentage of change | Standard Deviation 17.9283 |
| GROUP 3: OTDN Product 2 | Summary of AAMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -17.088 percentage of change | Standard Deviation 22.3929 |
| GROUP 3: OTDN Product 2 | Summary of AAMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -11.986 percentage of change | Standard Deviation 25.3885 |
| GROUP 4: OTDN Product 1 | Summary of AAMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -43.579 percentage of change | Standard Deviation 35.6609 |
| GROUP 4: OTDN Product 1 | Summary of AAMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -53.682 percentage of change | Standard Deviation 18.2362 |
| GROUP 5: OTDN Product 2 | Summary of AAMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -53.493 percentage of change | Standard Deviation 21.2336 |
| GROUP 5: OTDN Product 2 | Summary of AAMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -57.436 percentage of change | Standard Deviation 15.7971 |
| GROUP 6: Tobacco Cessation | Summary of AAMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -45.335 percentage of change | Standard Deviation 20.0234 |
| GROUP 6: Tobacco Cessation | Summary of AAMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -51.247 percentage of change | Standard Deviation 20.0931 |
Secondary
Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Summary of 2-cyanoethylmercapturic acid (CEMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.25 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Time frame: Baseline (Day -1), Day 5 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 242.647 ug/24 hour | Standard Deviation 100.2513 |
| GROUP 1: Continue Smoking | Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -10.097 ug/24 hour | Standard Deviation 61.2663 |
| GROUP 1: Continue Smoking | Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -17.672 ug/24 hour | Standard Deviation 59.2731 |
| GROUP 1: Continue Smoking | Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 252.743 ug/24 hour | Standard Deviation 95.7493 |
| GROUP 1: Continue Smoking | Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 235.071 ug/24 hour | Standard Deviation 83.9199 |
| GROUP 2: OTDN Product 1 | Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -99.937 ug/24 hour | Standard Deviation 66.7027 |
| GROUP 2: OTDN Product 1 | Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 156.653 ug/24 hour | Standard Deviation 67.8784 |
| GROUP 2: OTDN Product 1 | Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 162.257 ug/24 hour | Standard Deviation 75.7299 |
| GROUP 2: OTDN Product 1 | Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -105.852 ug/24 hour | Standard Deviation 61.4166 |
| GROUP 2: OTDN Product 1 | Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 262.505 ug/24 hour | Standard Deviation 105.5709 |
| GROUP 3: OTDN Product 2 | Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 169.389 ug/24 hour | Standard Deviation 75.8871 |
| GROUP 3: OTDN Product 2 | Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -114.284 ug/24 hour | Standard Deviation 90.2413 |
| GROUP 3: OTDN Product 2 | Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -113.677 ug/24 hour | Standard Deviation 83.6432 |
| GROUP 3: OTDN Product 2 | Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 283.673 ug/24 hour | Standard Deviation 126.9412 |
| GROUP 3: OTDN Product 2 | Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 169.996 ug/24 hour | Standard Deviation 77.5677 |
| GROUP 4: OTDN Product 1 | Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -229.521 ug/24 hour | Standard Deviation 123.5594 |
| GROUP 4: OTDN Product 1 | Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 36.060 ug/24 hour | Standard Deviation 18.6284 |
| GROUP 4: OTDN Product 1 | Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 34.356 ug/24 hour | Standard Deviation 24.5937 |
| GROUP 4: OTDN Product 1 | Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -231.814 ug/24 hour | Standard Deviation 130.723 |
| GROUP 4: OTDN Product 1 | Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 265.581 ug/24 hour | Standard Deviation 136.7904 |
| GROUP 5: OTDN Product 2 | Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 33.700 ug/24 hour | Standard Deviation 14.6351 |
| GROUP 5: OTDN Product 2 | Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 255.488 ug/24 hour | Standard Deviation 89.9874 |
| GROUP 5: OTDN Product 2 | Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 37.816 ug/24 hour | Standard Deviation 16.3173 |
| GROUP 5: OTDN Product 2 | Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -217.672 ug/24 hour | Standard Deviation 78.909 |
| GROUP 5: OTDN Product 2 | Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -222.204 ug/24 hour | Standard Deviation 82.1047 |
| GROUP 6: Tobacco Cessation | Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -216.801 ug/24 hour | Standard Deviation 79.58 |
| GROUP 6: Tobacco Cessation | Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 255.411 ug/24 hour | Standard Deviation 88.5824 |
| GROUP 6: Tobacco Cessation | Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 35.135 ug/24 hour | Standard Deviation 16.914 |
| GROUP 6: Tobacco Cessation | Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -218.763 ug/24 hour | Standard Deviation 82.4287 |
| GROUP 6: Tobacco Cessation | Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 36.648 ug/24 hour | Standard Deviation 17.0519 |
Comparison: Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (PP Population)p-value: <0.000195% CI: [5.315, 5.52]Mixed Models Analysis
Comparison: Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (PP Population)p-value: <0.000195% CI: [5.324, 5.548]Mixed Models Analysis
Comparison: Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (PP Population)p-value: <0.000195% CI: [4.86, 5.053]Mixed Models Analysis
Comparison: Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (PP Population)p-value: <0.000195% CI: [4.867, 5.081]Mixed Models Analysis
Comparison: Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (PP Population)p-value: <0.000195% CI: [4.886, 5.082]Mixed Models Analysis
Comparison: Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (PP Population)p-value: <0.000195% CI: [4.868, 5.082]Mixed Models Analysis
Comparison: Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (PP Population)p-value: <0.000195% CI: [3.367, 3.612]Mixed Models Analysis
Comparison: Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (PP Population)p-value: <0.000195% CI: [3.212, 3.483]Mixed Models Analysis
Comparison: Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (PP Population)p-value: <0.000195% CI: [3.418, 3.66]Mixed Models Analysis
Comparison: Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (PP Population)p-value: <0.000195% CI: [3.284, 3.554]Mixed Models Analysis
Comparison: Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (PP Population)p-value: <0.000195% CI: [3.373, 3.611]Mixed Models Analysis
Comparison: Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (PP Population)p-value: <0.000195% CI: [3.306, 3.568]Mixed Models Analysis
Comparison: Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (PP Population)p-value: <0.000195% CI: [-0.66, -0.262]Mixed Models Analysis
Comparison: Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (PP Population)p-value: <0.000195% CI: [-0.679, -0.244]Mixed Models Analysis
Comparison: Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (PP Population)p-value: <0.000195% CI: [-0.633, -0.233]Mixed Models Analysis
Comparison: Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (PP Population)p-value: <0.000195% CI: [-0.678, -0.244]Mixed Models Analysis
Comparison: Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (PP Population)p-value: <0.000195% CI: [-2.154, -1.701]Mixed Models Analysis
Comparison: Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (PP Population)p-value: <0.000195% CI: [-2.336, -1.842]Mixed Models Analysis
Comparison: Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (PP Population)p-value: <0.000195% CI: [-2.102, -1.656]Mixed Models Analysis
Comparison: Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (PP Population)p-value: <0.000195% CI: [-2.262, -1.772]Mixed Models Analysis
Comparison: Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (PP Population)p-value: <0.000195% CI: [1.25, 1.679]Mixed Models Analysis
Comparison: Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (PP Population)p-value: <0.000195% CI: [1.303, 1.772]Mixed Models Analysis
Comparison: Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (PP Population)p-value: <0.000195% CI: [1.277, 1.707]Mixed Models Analysis
Comparison: Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (PP Population)p-value: <0.000195% CI: [1.304, 1.772]Mixed Models Analysis
Comparison: Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (PP Population)p-value: 195% CI: [-0.242, 0.237]Mixed Models Analysis
Comparison: Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (PP Population)p-value: 0.939995% CI: [-0.351, 0.172]Mixed Models Analysis
Comparison: Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (PP Population)p-value: 0.999395% CI: [-0.19, 0.283]Mixed Models Analysis
Comparison: Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (PP Population)p-value: 195% CI: [-0.278, 0.242]Mixed Models Analysis
Secondary
Summary of CEMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Summary of 2-cyanoethylmercapturic acid (CEMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.25 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %
Time frame: Day 5 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of CEMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -1.763 percentage of change | Standard Deviation 32.1658 |
| GROUP 1: Continue Smoking | Summary of CEMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -0.027 percentage of change | Standard Deviation 35.0628 |
| GROUP 2: OTDN Product 1 | Summary of CEMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -39.043 percentage of change | Standard Deviation 15.611 |
| GROUP 2: OTDN Product 1 | Summary of CEMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -37.125 percentage of change | Standard Deviation 15.0814 |
| GROUP 3: OTDN Product 2 | Summary of CEMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -37.945 percentage of change | Standard Deviation 16.1205 |
| GROUP 3: OTDN Product 2 | Summary of CEMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -38.185 percentage of change | Standard Deviation 15.7489 |
| GROUP 4: OTDN Product 1 | Summary of CEMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -85.459 percentage of change | Standard Deviation 5.5487 |
| GROUP 4: OTDN Product 1 | Summary of CEMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -86.194 percentage of change | Standard Deviation 10.0102 |
| GROUP 5: OTDN Product 2 | Summary of CEMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -85.106 percentage of change | Standard Deviation 4.6221 |
| GROUP 5: OTDN Product 2 | Summary of CEMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -86.538 percentage of change | Standard Deviation 3.848 |
| GROUP 6: Tobacco Cessation | Summary of CEMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -84.942 percentage of change | Standard Deviation 6.4947 |
| GROUP 6: Tobacco Cessation | Summary of CEMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -85.900 percentage of change | Standard Deviation 5.1478 |
Secondary
Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Summary of N-acetyl-S-(2-carbamoyl-2-hydroxyethyl)-l-cysteine (GAMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (1 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Time frame: Baseline (Day -1), Day 5 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -0.029 ug/24 hour | Standard Deviation 6.6123 |
| GROUP 1: Continue Smoking | Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 28.123 ug/24 hour | Standard Deviation 9.0482 |
| GROUP 1: Continue Smoking | Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 28.151 ug/24 hour | Standard Deviation 7.9362 |
| GROUP 1: Continue Smoking | Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -0.842 ug/24 hour | Standard Deviation 5.6395 |
| GROUP 1: Continue Smoking | Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 27.310 ug/24 hour | Standard Deviation 8.8508 |
| GROUP 2: OTDN Product 1 | Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 24.988 ug/24 hour | Standard Deviation 8.6134 |
| GROUP 2: OTDN Product 1 | Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -5.349 ug/24 hour | Standard Deviation 6.0495 |
| GROUP 2: OTDN Product 1 | Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 30.337 ug/24 hour | Standard Deviation 9.1426 |
| GROUP 2: OTDN Product 1 | Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -5.562 ug/24 hour | Standard Deviation 5.0722 |
| GROUP 2: OTDN Product 1 | Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 24.808 ug/24 hour | Standard Deviation 9.1001 |
| GROUP 3: OTDN Product 2 | Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 26.343 ug/24 hour | Standard Deviation 9.3111 |
| GROUP 3: OTDN Product 2 | Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -4.072 ug/24 hour | Standard Deviation 8.5389 |
| GROUP 3: OTDN Product 2 | Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -4.714 ug/24 hour | Standard Deviation 8.9415 |
| GROUP 3: OTDN Product 2 | Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 25.701 ug/24 hour | Standard Deviation 9.1838 |
| GROUP 3: OTDN Product 2 | Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 30.415 ug/24 hour | Standard Deviation 12.2998 |
| GROUP 4: OTDN Product 1 | Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 14.184 ug/24 hour | Standard Deviation 6.1136 |
| GROUP 4: OTDN Product 1 | Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 25.403 ug/24 hour | Standard Deviation 7.9934 |
| GROUP 4: OTDN Product 1 | Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 15.898 ug/24 hour | Standard Deviation 6.4032 |
| GROUP 4: OTDN Product 1 | Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -9.504 ug/24 hour | Standard Deviation 8.2824 |
| GROUP 4: OTDN Product 1 | Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -11.525 ug/24 hour | Standard Deviation 7.763 |
| GROUP 5: OTDN Product 2 | Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -11.190 ug/24 hour | Standard Deviation 7.8064 |
| GROUP 5: OTDN Product 2 | Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 26.270 ug/24 hour | Standard Deviation 9.0014 |
| GROUP 5: OTDN Product 2 | Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -12.681 ug/24 hour | Standard Deviation 7.5912 |
| GROUP 5: OTDN Product 2 | Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 15.080 ug/24 hour | Standard Deviation 5.3359 |
| GROUP 5: OTDN Product 2 | Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 14.272 ug/24 hour | Standard Deviation 5.0565 |
| GROUP 6: Tobacco Cessation | Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 30.737 ug/24 hour | Standard Deviation 10.1313 |
| GROUP 6: Tobacco Cessation | Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -12.754 ug/24 hour | Standard Deviation 7.9808 |
| GROUP 6: Tobacco Cessation | Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 17.982 ug/24 hour | Standard Deviation 8.1223 |
| GROUP 6: Tobacco Cessation | Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -11.638 ug/24 hour | Standard Deviation 7.8765 |
| GROUP 6: Tobacco Cessation | Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 18.856 ug/24 hour | Standard Deviation 6.6119 |
Comparison: Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [3.208, 3.379]Mixed Models Analysis
Comparison: Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [3.176, 3.348]Mixed Models Analysis
Comparison: Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [3.039, 3.202]Mixed Models Analysis
Comparison: Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [3.017, 3.181]Mixed Models Analysis
Comparison: Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [3.1, 3.264]Mixed Models Analysis
Comparison: Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [3.066, 3.231]Mixed Models Analysis
Comparison: Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [2.673, 2.881]Mixed Models Analysis
Comparison: Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [2.546, 2.756]Mixed Models Analysis
Comparison: Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [2.618, 2.823]Mixed Models Analysis
Comparison: Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [2.544, 2.753]Mixed Models Analysis
Comparison: Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [2.651, 2.851]Mixed Models Analysis
Comparison: Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [2.718, 2.919]Mixed Models Analysis
Comparison: Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: 0.037795% CI: [-0.34, -0.006]Mixed Models Analysis
Comparison: Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: 0.064395% CI: [-0.331, 0.006]Mixed Models Analysis
Comparison: Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: 0.387595% CI: [-0.279, 0.056]Mixed Models Analysis
Comparison: Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: 0.372595% CI: [-0.28, 0.054]Mixed Models Analysis
Comparison: Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: <0.000195% CI: [-0.706, -0.327]Mixed Models Analysis
Comparison: Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-0.802, -0.42]Mixed Models Analysis
Comparison: Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: <0.000195% CI: [-0.76, -0.386]Mixed Models Analysis
Comparison: Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-0.803, -0.423]Mixed Models Analysis
Comparison: Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: <0.000195% CI: [0.19, 0.548]Mixed Models Analysis
Comparison: Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 0.000395% CI: [0.099, 0.462]Mixed Models Analysis
Comparison: Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: <0.000195% CI: [0.251, 0.611]Mixed Models Analysis
Comparison: Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: <0.000195% CI: [0.149, 0.511]Mixed Models Analysis
Comparison: Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 195% CI: [-0.176, 0.228]Mixed Models Analysis
Comparison: Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 0.158995% CI: [-0.371, 0.036]Mixed Models Analysis
Comparison: Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 0.999995% CI: [-0.23, 0.168]Mixed Models Analysis
Comparison: Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 0.145395% CI: [-0.372, 0.032]Mixed Models Analysis
Secondary
Summary of GAMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Summary of N-acetyl-S-(2-carbamoyl-2-hydroxyethyl)-l-cysteine (GAMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (1 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %
Time frame: Day 5 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of GAMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -1.515 percentage of change | Standard Deviation 21.1321 |
| GROUP 1: Continue Smoking | Summary of GAMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | 2.015 percentage of change | Standard Deviation 23.0063 |
| GROUP 2: OTDN Product 1 | Summary of GAMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -18.456 percentage of change | Standard Deviation 16.3993 |
| GROUP 2: OTDN Product 1 | Summary of GAMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -16.449 percentage of change | Standard Deviation 19.0682 |
| GROUP 3: OTDN Product 2 | Summary of GAMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -11.236 percentage of change | Standard Deviation 24.0586 |
| GROUP 3: OTDN Product 2 | Summary of GAMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -9.361 percentage of change | Standard Deviation 23.09 |
| GROUP 4: OTDN Product 1 | Summary of GAMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -43.200 percentage of change | Standard Deviation 19.3353 |
| GROUP 4: OTDN Product 1 | Summary of GAMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -34.427 percentage of change | Standard Deviation 25.2883 |
| GROUP 5: OTDN Product 2 | Summary of GAMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -39.251 percentage of change | Standard Deviation 22.4238 |
| GROUP 5: OTDN Product 2 | Summary of GAMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -44.682 percentage of change | Standard Deviation 19.308 |
| GROUP 6: Tobacco Cessation | Summary of GAMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -40.803 percentage of change | Standard Deviation 18.2548 |
| GROUP 6: Tobacco Cessation | Summary of GAMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -36.587 percentage of change | Standard Deviation 16.0285 |
Secondary
Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Summary of 2-hydroxyethyl mercapturic acid (HEMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.2 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Time frame: Baseline (Day -1), Day 5 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -2.165 ug/24 hour | Standard Deviation 4.4766 |
| GROUP 1: Continue Smoking | Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 11.473 ug/24 hour | Standard Deviation 6.2511 |
| GROUP 1: Continue Smoking | Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 13.637 ug/24 hour | Standard Deviation 6.7273 |
| GROUP 1: Continue Smoking | Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -2.322 ug/24 hour | Standard Deviation 4.9621 |
| GROUP 1: Continue Smoking | Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 11.316 ug/24 hour | Standard Deviation 5.6391 |
| GROUP 2: OTDN Product 1 | Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 12.822 ug/24 hour | Standard Deviation 9.6015 |
| GROUP 2: OTDN Product 1 | Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -5.023 ug/24 hour | Standard Deviation 6.757 |
| GROUP 2: OTDN Product 1 | Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 17.845 ug/24 hour | Standard Deviation 12.7203 |
| GROUP 2: OTDN Product 1 | Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -5.806 ug/24 hour | Standard Deviation 7.8918 |
| GROUP 2: OTDN Product 1 | Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 12.475 ug/24 hour | Standard Deviation 8.8931 |
| GROUP 3: OTDN Product 2 | Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 10.819 ug/24 hour | Standard Deviation 6.9893 |
| GROUP 3: OTDN Product 2 | Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -4.910 ug/24 hour | Standard Deviation 7.9708 |
| GROUP 3: OTDN Product 2 | Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -5.158 ug/24 hour | Standard Deviation 8.3038 |
| GROUP 3: OTDN Product 2 | Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 10.571 ug/24 hour | Standard Deviation 6.4028 |
| GROUP 3: OTDN Product 2 | Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 15.730 ug/24 hour | Standard Deviation 12.9229 |
| GROUP 4: OTDN Product 1 | Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 8.393 ug/24 hour | Standard Deviation 6.3959 |
| GROUP 4: OTDN Product 1 | Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 17.668 ug/24 hour | Standard Deviation 15.0939 |
| GROUP 4: OTDN Product 1 | Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 8.768 ug/24 hour | Standard Deviation 6.5494 |
| GROUP 4: OTDN Product 1 | Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -8.900 ug/24 hour | Standard Deviation 12.5444 |
| GROUP 4: OTDN Product 1 | Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -9.383 ug/24 hour | Standard Deviation 12.2677 |
| GROUP 5: OTDN Product 2 | Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -8.897 ug/24 hour | Standard Deviation 9.5751 |
| GROUP 5: OTDN Product 2 | Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 20.015 ug/24 hour | Standard Deviation 12.5156 |
| GROUP 5: OTDN Product 2 | Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -9.865 ug/24 hour | Standard Deviation 10.8247 |
| GROUP 5: OTDN Product 2 | Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 11.119 ug/24 hour | Standard Deviation 6.96 |
| GROUP 5: OTDN Product 2 | Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 10.289 ug/24 hour | Standard Deviation 5.6391 |
| GROUP 6: Tobacco Cessation | Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 17.608 ug/24 hour | Standard Deviation 12.9125 |
| GROUP 6: Tobacco Cessation | Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -9.493 ug/24 hour | Standard Deviation 9.9659 |
| GROUP 6: Tobacco Cessation | Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 8.115 ug/24 hour | Standard Deviation 5.1282 |
| GROUP 6: Tobacco Cessation | Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -8.385 ug/24 hour | Standard Deviation 10.4569 |
| GROUP 6: Tobacco Cessation | Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 9.284 ug/24 hour | Standard Deviation 7.0913 |
Comparison: Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [2.283, 2.531]Mixed Models Analysis
Comparison: Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [2.253, 2.543]Mixed Models Analysis
Comparison: Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [2.187, 2.42]Mixed Models Analysis
Comparison: Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [2.112, 2.389]Mixed Models Analysis
Comparison: Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [2.166, 2.404]Mixed Models Analysis
Comparison: Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [2.133, 2.412]Mixed Models Analysis
Comparison: Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [1.844, 2.14]Mixed Models Analysis
Comparison: Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [1.719, 2.069]Mixed Models Analysis
Comparison: Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [1.955, 2.248]Mixed Models Analysis
Comparison: Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [1.9, 2.25]Mixed Models Analysis
Comparison: Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [1.746, 2.033]Mixed Models Analysis
Comparison: Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [1.775, 2.114]Mixed Models Analysis
Comparison: Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: 0.867495% CI: [-0.345, 0.137]Mixed Models Analysis
Comparison: Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: 0.651995% CI: [-0.429, 0.133]Mixed Models Analysis
Comparison: Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: 0.730195% CI: [-0.363, 0.119]Mixed Models Analysis
Comparison: Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: 0.807695% CI: [-0.405, 0.154]Mixed Models Analysis
Comparison: Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: 0.000495% CI: [-0.689, -0.142]Mixed Models Analysis
Comparison: Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: 0.000295% CI: [-0.822, -0.185]Mixed Models Analysis
Comparison: Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: 0.018395% CI: [-0.578, -0.034]Mixed Models Analysis
Comparison: Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: 0.044395% CI: [-0.641, -0.005]Mixed Models Analysis
Comparison: Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 0.000295% CI: [0.155, 0.672]Mixed Models Analysis
Comparison: Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 0.045495% CI: [0.004, 0.608]Mixed Models Analysis
Comparison: Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 0.000495% CI: [0.136, 0.655]Mixed Models Analysis
Comparison: Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 0.026195% CI: [0.026, 0.63]Mixed Models Analysis
Comparison: Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 0.945595% CI: [-0.187, 0.392]Mixed Models Analysis
Comparison: Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 0.999995% CI: [-0.387, 0.287]Mixed Models Analysis
Comparison: Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 0.263395% CI: [-0.074, 0.498]Mixed Models Analysis
Comparison: Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 0.876995% CI: [-0.205, 0.465]Mixed Models Analysis
Secondary
Summary of HEMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Summary of 2-hydroxyethyl mercapturic acid (HEMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.2 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %
Time frame: Day 5 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of HEMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -9.584 percentage of change | Standard Deviation 33.1121 |
| GROUP 1: Continue Smoking | Summary of HEMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -8.742 percentage of change | Standard Deviation 37.0142 |
| GROUP 2: OTDN Product 1 | Summary of HEMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -22.916 percentage of change | Standard Deviation 29.9492 |
| GROUP 2: OTDN Product 1 | Summary of HEMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -26.992 percentage of change | Standard Deviation 30.625 |
| GROUP 3: OTDN Product 2 | Summary of HEMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -21.244 percentage of change | Standard Deviation 28.9372 |
| GROUP 3: OTDN Product 2 | Summary of HEMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -21.940 percentage of change | Standard Deviation 27.9936 |
| GROUP 4: OTDN Product 1 | Summary of HEMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -39.163 percentage of change | Standard Deviation 28.8018 |
| GROUP 4: OTDN Product 1 | Summary of HEMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -43.496 percentage of change | Standard Deviation 27.6577 |
| GROUP 5: OTDN Product 2 | Summary of HEMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -37.608 percentage of change | Standard Deviation 30.2394 |
| GROUP 5: OTDN Product 2 | Summary of HEMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -37.026 percentage of change | Standard Deviation 42.9784 |
| GROUP 6: Tobacco Cessation | Summary of HEMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -48.200 percentage of change | Standard Deviation 21.7805 |
| GROUP 6: Tobacco Cessation | Summary of HEMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -40.293 percentage of change | Standard Deviation 31.7717 |
Secondary
Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population)
Summary of nicotine equivalents amount excreted (mg/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) for each metabolite were set to one-half of the LLOQ for the calculation of nicotine equivalents. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Nicotine equivalents (mg/g creatinine) = nicotine equivalents (μg/mL) x 100 / creatinine (mg/dL) Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Time frame: Baseline (Day -1), Day 5 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -0.590 mg/24 hour | Standard Deviation 3.3816 |
| GROUP 1: Continue Smoking | Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 16.297 mg/24 hour | Standard Deviation 5.4573 |
| GROUP 1: Continue Smoking | Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 16.887 mg/24 hour | Standard Deviation 5.4959 |
| GROUP 1: Continue Smoking | Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -0.055 mg/24 hour | Standard Deviation 3.6896 |
| GROUP 1: Continue Smoking | Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 16.832 mg/24 hour | Standard Deviation 5.8963 |
| GROUP 2: OTDN Product 1 | Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 12.330 mg/24 hour | Standard Deviation 4.0796 |
| GROUP 2: OTDN Product 1 | Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -5.167 mg/24 hour | Standard Deviation 4.8936 |
| GROUP 2: OTDN Product 1 | Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 17.497 mg/24 hour | Standard Deviation 5.9794 |
| GROUP 2: OTDN Product 1 | Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -4.429 mg/24 hour | Standard Deviation 3.9681 |
| GROUP 2: OTDN Product 1 | Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 12.832 mg/24 hour | Standard Deviation 4.1984 |
| GROUP 3: OTDN Product 2 | Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 15.024 mg/24 hour | Standard Deviation 5.573 |
| GROUP 3: OTDN Product 2 | Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -2.880 mg/24 hour | Standard Deviation 4.7547 |
| GROUP 3: OTDN Product 2 | Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -2.541 mg/24 hour | Standard Deviation 4.6321 |
| GROUP 3: OTDN Product 2 | Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 15.363 mg/24 hour | Standard Deviation 6.1114 |
| GROUP 3: OTDN Product 2 | Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 17.904 mg/24 hour | Standard Deviation 7.1881 |
| GROUP 4: OTDN Product 1 | Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 5.476 mg/24 hour | Standard Deviation 7.3802 |
| GROUP 4: OTDN Product 1 | Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 15.991 mg/24 hour | Standard Deviation 5.8914 |
| GROUP 4: OTDN Product 1 | Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 5.459 mg/24 hour | Standard Deviation 6.7089 |
| GROUP 4: OTDN Product 1 | Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -10.532 mg/24 hour | Standard Deviation 6.5032 |
| GROUP 4: OTDN Product 1 | Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -10.571 mg/24 hour | Standard Deviation 7.2563 |
| GROUP 5: OTDN Product 2 | Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -7.561 mg/24 hour | Standard Deviation 6.9238 |
| GROUP 5: OTDN Product 2 | Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 15.752 mg/24 hour | Standard Deviation 4.983 |
| GROUP 5: OTDN Product 2 | Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -8.555 mg/24 hour | Standard Deviation 6.1938 |
| GROUP 5: OTDN Product 2 | Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 8.191 mg/24 hour | Standard Deviation 5.9189 |
| GROUP 5: OTDN Product 2 | Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 7.437 mg/24 hour | Standard Deviation 5.1587 |
| GROUP 6: Tobacco Cessation | Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 16.279 mg/24 hour | Standard Deviation 4.9702 |
| GROUP 6: Tobacco Cessation | Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -15.611 mg/24 hour | Standard Deviation 4.8231 |
| GROUP 6: Tobacco Cessation | Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 0.668 mg/24 hour | Standard Deviation 0.3787 |
| GROUP 6: Tobacco Cessation | Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -15.580 mg/24 hour | Standard Deviation 4.8301 |
| GROUP 6: Tobacco Cessation | Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 0.481 mg/24 hour | Standard Deviation 0.2954 |
Comparison: Null hypothesis: NE amount excreted (mg/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [2.519, 2.863]Mixed Models Analysis
Comparison: Null hypothesis: NE amount excreted (mg/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [2.546, 2.89]Mixed Models Analysis
Comparison: Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [2.252, 2.577]Mixed Models Analysis
Comparison: Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [2.276, 2.603]Mixed Models Analysis
Comparison: Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [2.417, 2.748]Mixed Models Analysis
Comparison: Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [2.426, 2.757]Mixed Models Analysis
Comparison: Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [0.901, 1.314]Mixed Models Analysis
Comparison: Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [0.81, 1.225]Mixed Models Analysis
Comparison: Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [1.624, 2.031]Mixed Models Analysis
Comparison: Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [1.577, 1.988]Mixed Models Analysis
Comparison: Null hypothesis: NE amount excreted (mg/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [-0.75, -0.35]Mixed Models Analysis
Comparison: Null hypothesis: NE amount excreted (mg/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [-1.051, -0.65]Mixed Models Analysis
Comparison: Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: 0.160895% CI: [-0.609, 0.057]Mixed Models Analysis
Comparison: Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: 0.157595% CI: [-0.613, 0.056]Mixed Models Analysis
Comparison: Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: 0.972895% CI: [-0.442, 0.226]Mixed Models Analysis
Comparison: Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: 0.926295% CI: [-0.461, 0.208]Mixed Models Analysis
Comparison: Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: <0.000195% CI: [-1.963, -1.204]Mixed Models Analysis
Comparison: Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-2.081, -1.32]Mixed Models Analysis
Comparison: Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: <0.000195% CI: [-1.237, -0.489]Mixed Models Analysis
Comparison: Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-1.312, -0.56]Mixed Models Analysis
Secondary
Summary of Nicotine Equivalents Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Summary of nicotine equivalents amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) for each metabolite were set to one-half of the LLOQ for the calculation of nicotine equivalents. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Nicotine equivalents (mg/g creatinine) = nicotine equivalents (μg/mL) x 100 / creatinine (mg/dL) % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %
Time frame: Day 5 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of Nicotine Equivalents Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -1.783 percentage of change | Standard Deviation 20.5643 |
| GROUP 1: Continue Smoking | Summary of Nicotine Equivalents Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | 0.870 percentage of change | Standard Deviation 21.7462 |
| GROUP 2: OTDN Product 1 | Summary of Nicotine Equivalents Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -25.070 percentage of change | Standard Deviation 23.91 |
| GROUP 2: OTDN Product 1 | Summary of Nicotine Equivalents Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -22.036 percentage of change | Standard Deviation 22.1901 |
| GROUP 3: OTDN Product 2 | Summary of Nicotine Equivalents Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -13.053 percentage of change | Standard Deviation 18.9294 |
| GROUP 3: OTDN Product 2 | Summary of Nicotine Equivalents Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -11.641 percentage of change | Standard Deviation 21.236 |
| GROUP 4: OTDN Product 1 | Summary of Nicotine Equivalents Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -68.537 percentage of change | Standard Deviation 37.0327 |
| GROUP 4: OTDN Product 1 | Summary of Nicotine Equivalents Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -67.749 percentage of change | Standard Deviation 33.9247 |
| GROUP 5: OTDN Product 2 | Summary of Nicotine Equivalents Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -45.240 percentage of change | Standard Deviation 41.5952 |
| GROUP 5: OTDN Product 2 | Summary of Nicotine Equivalents Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -51.521 percentage of change | Standard Deviation 35.9795 |
| GROUP 6: Tobacco Cessation | Summary of Nicotine Equivalents Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -95.808 percentage of change | Standard Deviation 1.9997 |
| GROUP 6: Tobacco Cessation | Summary of Nicotine Equivalents Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -96.968 percentage of change | Standard Deviation 1.4462 |
Secondary
Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population)
Summary of N-nitrosonornicotine (NNN) amount excreted (ng/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.500 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Time frame: Baseline (Day -1), Day 5 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -1.434 ng/24 hour | Standard Deviation 6.277 |
| GROUP 1: Continue Smoking | Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 15.718 ng/24 hour | Standard Deviation 12.1674 |
| GROUP 1: Continue Smoking | Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 17.153 ng/24 hour | Standard Deviation 14.5452 |
| GROUP 1: Continue Smoking | Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -0.932 ng/24 hour | Standard Deviation 7.8298 |
| GROUP 1: Continue Smoking | Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 16.221 ng/24 hour | Standard Deviation 11.7555 |
| GROUP 2: OTDN Product 1 | Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 14.414 ng/24 hour | Standard Deviation 23.0907 |
| GROUP 2: OTDN Product 1 | Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -11.324 ng/24 hour | Standard Deviation 20.7146 |
| GROUP 2: OTDN Product 1 | Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 25.737 ng/24 hour | Standard Deviation 32.2433 |
| GROUP 2: OTDN Product 1 | Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | 9.323 ng/24 hour | Standard Deviation 143.07 |
| GROUP 2: OTDN Product 1 | Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 34.944 ng/24 hour | Standard Deviation 142.4443 |
| GROUP 3: OTDN Product 2 | Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 13.367 ng/24 hour | Standard Deviation 20.6899 |
| GROUP 3: OTDN Product 2 | Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -6.888 ng/24 hour | Standard Deviation 21.1344 |
| GROUP 3: OTDN Product 2 | Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | 6.288 ng/24 hour | Standard Deviation 95.6402 |
| GROUP 3: OTDN Product 2 | Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 26.542 ng/24 hour | Standard Deviation 94.8042 |
| GROUP 3: OTDN Product 2 | Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 20.254 ng/24 hour | Standard Deviation 12.7633 |
| GROUP 4: OTDN Product 1 | Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 0.902 ng/24 hour | Standard Deviation 1.3344 |
| GROUP 4: OTDN Product 1 | Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 37.567 ng/24 hour | Standard Deviation 93.0133 |
| GROUP 4: OTDN Product 1 | Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 1.524 ng/24 hour | Standard Deviation 1.8065 |
| GROUP 4: OTDN Product 1 | Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -36.042 ng/24 hour | Standard Deviation 92.0468 |
| GROUP 4: OTDN Product 1 | Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -37.431 ng/24 hour | Standard Deviation 94.9572 |
| GROUP 5: OTDN Product 2 | Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -15.562 ng/24 hour | Standard Deviation 27.2973 |
| GROUP 5: OTDN Product 2 | Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 21.096 ng/24 hour | Standard Deviation 17.4601 |
| GROUP 5: OTDN Product 2 | Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -18.669 ng/24 hour | Standard Deviation 16.6816 |
| GROUP 5: OTDN Product 2 | Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 5.535 ng/24 hour | Standard Deviation 23.7712 |
| GROUP 5: OTDN Product 2 | Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 1.876 ng/24 hour | Standard Deviation 3.8928 |
| GROUP 6: Tobacco Cessation | Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 20.271 ng/24 hour | Standard Deviation 15.2179 |
| GROUP 6: Tobacco Cessation | Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -19.303 ng/24 hour | Standard Deviation 15.2298 |
| GROUP 6: Tobacco Cessation | Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 0.968 ng/24 hour | Standard Deviation 0.7968 |
| GROUP 6: Tobacco Cessation | Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -19.532 ng/24 hour | Standard Deviation 15.8782 |
| GROUP 6: Tobacco Cessation | Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 1.166 ng/24 hour | Standard Deviation 1.5528 |
Comparison: Null hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [2.317, 2.94]Mixed Models Analysis
Comparison: Null hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [2.321, 2.943]Mixed Models Analysis
Comparison: Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [1.714, 2.298]Mixed Models Analysis
Comparison: Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [1.847, 2.44]Mixed Models Analysis
Comparison: Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [1.69, 2.284]Mixed Models Analysis
Comparison: Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [1.964, 2.559]Mixed Models Analysis
Comparison: Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)p-value: 0.165895% CI: [-0.635, 0.109]Mixed Models Analysis
Comparison: Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)p-value: 0.000795% CI: [-1.036, -0.282]Mixed Models Analysis
Comparison: Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)p-value: 0.105595% CI: [-0.667, 0.064]Mixed Models Analysis
Comparison: Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)p-value: 0.20495% CI: [-0.617, 0.132]Mixed Models Analysis
Comparison: Null hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)p-value: 0.182995% CI: [-0.603, 0.116]Mixed Models Analysis
Comparison: Null hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)p-value: 0.180195% CI: [-0.612, 0.115]Mixed Models Analysis
Comparison: Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: 0.039195% CI: [-1.225, -0.019]Mixed Models Analysis
Comparison: Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: 0.186495% CI: [-1.096, 0.119]Mixed Models Analysis
Comparison: Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: 0.03195% CI: [-1.246, -0.037]Mixed Models Analysis
Comparison: Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: 0.03195% CI: [-1.246, -0.037]Mixed Models Analysis
Comparison: Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: <0.000195% CI: [-3.58, -2.202]Mixed Models Analysis
Comparison: Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-3.985, -2.597]Mixed Models Analysis
Comparison: Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: <0.000195% CI: [-3.605, -2.255]Mixed Models Analysis
Comparison: Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-3.559, -2.19]Mixed Models Analysis
Comparison: Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: <0.000195% CI: [1.604, 2.896]Mixed Models Analysis
Comparison: Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: <0.000195% CI: [1.737, 3.046]Mixed Models Analysis
Comparison: Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: <0.000195% CI: [1.582, 2.879]Mixed Models Analysis
Comparison: Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: <0.000195% CI: [1.857, 3.162]Mixed Models Analysis
Comparison: Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 195% CI: [-0.743, 0.705]Mixed Models Analysis
Comparison: Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 0.563995% CI: [-1.142, 0.32]Mixed Models Analysis
Comparison: Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 195% CI: [-0.771, 0.656]Mixed Models Analysis
Comparison: Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 195% CI: [-0.721, 0.732]Mixed Models Analysis
Secondary
Summary of NNN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Summary of N-nitrosonornicotine (NNN) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.500 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %
Time frame: Day 5 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of NNN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | 17.679 percentage of change | Standard Deviation 135.995 |
| GROUP 1: Continue Smoking | Summary of NNN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | 11.041 percentage of change | Standard Deviation 67.8187 |
| GROUP 2: OTDN Product 1 | Summary of NNN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -39.207 percentage of change | Standard Deviation 55.144 |
| GROUP 2: OTDN Product 1 | Summary of NNN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | 39.909 percentage of change | Standard Deviation 533.3498 |
| GROUP 3: OTDN Product 2 | Summary of NNN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -29.116 percentage of change | Standard Deviation 121.2696 |
| GROUP 3: OTDN Product 2 | Summary of NNN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | 110.644 percentage of change | Standard Deviation 699.0961 |
| GROUP 4: OTDN Product 1 | Summary of NNN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -90.367 percentage of change | Standard Deviation 14.4687 |
| GROUP 4: OTDN Product 1 | Summary of NNN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -93.379 percentage of change | Standard Deviation 11.0686 |
| GROUP 5: OTDN Product 2 | Summary of NNN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -79.576 percentage of change | Standard Deviation 68.3202 |
| GROUP 5: OTDN Product 2 | Summary of NNN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -88.301 percentage of change | Standard Deviation 16.9805 |
| GROUP 6: Tobacco Cessation | Summary of NNN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -89.967 percentage of change | Standard Deviation 21.7083 |
| GROUP 6: Tobacco Cessation | Summary of NNN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -73.064 percentage of change | Standard Deviation 101.7367 |
Secondary
Summary of Response for Willingness to Use Cigarettes Again Bipolar VAS Scores for Cigarettes by Category, Study Group and Study Product (mITT Population)
Summary of subject responses to Use the Product (Cigarette) Again Bipolar Visual Analogue Scale (VAS) Scores for cigarettes is presented. The Use the Product Again Bipolar VAS is a 100 mm scale ranging from 0 mm (Definitely Would Not) to 100 mm (Definitely Would). The bipolar score is calculated by subtracting 50 from the original VAS score, then categorizing into three categories: -50 to \<0, 0, and \>0 to 50. Higher scores are associated with greater willingness to use the cigarettes again. Mean and standard deviation of the bipolar VAS score per category is shown. The Use the Product Again VAS Score was given to subjects on Day 7 at 21:30 (±30 minutes) during the product use period. The data shown are the means calculated from only those participants with scores in the corresponding category ('-50 to \<0', '0' and '\>0 to 50').
Time frame: Data collected on Day 7 at 21:30 (±30 minutes) during the product use period
Population: The mITT population consisted of all randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure. Only subjects who were smoked their own cigarette brand were asked to complete the Use Product (Cigarette) Again VAS score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of Response for Willingness to Use Cigarettes Again Bipolar VAS Scores for Cigarettes by Category, Study Group and Study Product (mITT Population) | 0 | 0.0 units on a scale | — |
| GROUP 1: Continue Smoking | Summary of Response for Willingness to Use Cigarettes Again Bipolar VAS Scores for Cigarettes by Category, Study Group and Study Product (mITT Population) | -50 to <0 | -3.0 units on a scale | — |
| GROUP 1: Continue Smoking | Summary of Response for Willingness to Use Cigarettes Again Bipolar VAS Scores for Cigarettes by Category, Study Group and Study Product (mITT Population) | >0 to 50 | 37.3 units on a scale | Standard Deviation 14.67 |
| GROUP 2: OTDN Product 1 | Summary of Response for Willingness to Use Cigarettes Again Bipolar VAS Scores for Cigarettes by Category, Study Group and Study Product (mITT Population) | 0 | 0.0 units on a scale | — |
| GROUP 2: OTDN Product 1 | Summary of Response for Willingness to Use Cigarettes Again Bipolar VAS Scores for Cigarettes by Category, Study Group and Study Product (mITT Population) | -50 to <0 | -20.7 units on a scale | Standard Deviation 18.14 |
| GROUP 2: OTDN Product 1 | Summary of Response for Willingness to Use Cigarettes Again Bipolar VAS Scores for Cigarettes by Category, Study Group and Study Product (mITT Population) | >0 to 50 | 37.1 units on a scale | Standard Deviation 14.92 |
| GROUP 3: OTDN Product 2 | Summary of Response for Willingness to Use Cigarettes Again Bipolar VAS Scores for Cigarettes by Category, Study Group and Study Product (mITT Population) | >0 to 50 | 30.8 units on a scale | Standard Deviation 16.13 |
| GROUP 3: OTDN Product 2 | Summary of Response for Willingness to Use Cigarettes Again Bipolar VAS Scores for Cigarettes by Category, Study Group and Study Product (mITT Population) | -50 to <0 | -17.0 units on a scale | Standard Deviation 15.8 |
Secondary
Summary of Response for Willingness to Use the VERVE® Product Again Bipolar VAS Scores for Cigarettes by Category, Study Group and Study Product (mITT Population)
Summary of subject responses to Use the Product (VERVE®) Again Bipolar Visual Analogue Scale (VAS) Scores for the VERVE® test products are presented. The Use the Product Again Bipolar VAS is a 100 mm scale ranging from 0 mm (Definitely Would Not) to 100 mm (Definitely Would). The bipolar score is calculated by subtracting 50 from the original VAS score, then categorizing into three categories: -50 to \<0, 0, and \>0 to 50. Higher scores are associated with greater willingness to use the VERVE® product again. Mean and standard deviation of the bipolar VAS score per category is shown. The Use the Product Again VAS Score was given to subjects on Day 7 at 21:30 (±30 minutes) during the product use period. The data shown are the means calculated from only those participants with scores in the corresponding category ('-50 to \<0', '0' and '\>0 to 50').
Time frame: Data collected on Day 7 at 21:30 (±30 minutes) during the product use period
Population: The mITT population consisted of all randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure. Only subjects who used the VERVE® product were asked to complete the Use Product (VERVE®) Again VAS score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of Response for Willingness to Use the VERVE® Product Again Bipolar VAS Scores for Cigarettes by Category, Study Group and Study Product (mITT Population) | -50 to <0 | -36.5 units on a scale | Standard Deviation 18.92 |
| GROUP 1: Continue Smoking | Summary of Response for Willingness to Use the VERVE® Product Again Bipolar VAS Scores for Cigarettes by Category, Study Group and Study Product (mITT Population) | 0 | 0.0 units on a scale | Standard Deviation 0 |
| GROUP 1: Continue Smoking | Summary of Response for Willingness to Use the VERVE® Product Again Bipolar VAS Scores for Cigarettes by Category, Study Group and Study Product (mITT Population) | >0 to 50 | 25.4 units on a scale | Standard Deviation 14.02 |
| GROUP 2: OTDN Product 1 | Summary of Response for Willingness to Use the VERVE® Product Again Bipolar VAS Scores for Cigarettes by Category, Study Group and Study Product (mITT Population) | 0 | 0.0 units on a scale | Standard Deviation 0 |
| GROUP 2: OTDN Product 1 | Summary of Response for Willingness to Use the VERVE® Product Again Bipolar VAS Scores for Cigarettes by Category, Study Group and Study Product (mITT Population) | -50 to <0 | -27.1 units on a scale | Standard Deviation 19.59 |
| GROUP 2: OTDN Product 1 | Summary of Response for Willingness to Use the VERVE® Product Again Bipolar VAS Scores for Cigarettes by Category, Study Group and Study Product (mITT Population) | >0 to 50 | 29.1 units on a scale | Standard Deviation 13.02 |
| GROUP 3: OTDN Product 2 | Summary of Response for Willingness to Use the VERVE® Product Again Bipolar VAS Scores for Cigarettes by Category, Study Group and Study Product (mITT Population) | -50 to <0 | -30.7 units on a scale | Standard Deviation 19.11 |
| GROUP 3: OTDN Product 2 | Summary of Response for Willingness to Use the VERVE® Product Again Bipolar VAS Scores for Cigarettes by Category, Study Group and Study Product (mITT Population) | >0 to 50 | 27.6 units on a scale | Standard Deviation 17.19 |
| GROUP 4: OTDN Product 1 | Summary of Response for Willingness to Use the VERVE® Product Again Bipolar VAS Scores for Cigarettes by Category, Study Group and Study Product (mITT Population) | 0 | 0.0 units on a scale | — |
| GROUP 4: OTDN Product 1 | Summary of Response for Willingness to Use the VERVE® Product Again Bipolar VAS Scores for Cigarettes by Category, Study Group and Study Product (mITT Population) | >0 to 50 | 31.0 units on a scale | Standard Deviation 15.59 |
| GROUP 4: OTDN Product 1 | Summary of Response for Willingness to Use the VERVE® Product Again Bipolar VAS Scores for Cigarettes by Category, Study Group and Study Product (mITT Population) | -50 to <0 | -27.3 units on a scale | Standard Deviation 15.7 |
Secondary
Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Summary of S-phenyl mercapturic acid (S-PMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.02 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Time frame: Baseline (Day -1), Day 5 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -0.026 ug/24 hour | Standard Deviation 1.8063 |
| GROUP 1: Continue Smoking | Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 6.935 ug/24 hour | Standard Deviation 3.7971 |
| GROUP 1: Continue Smoking | Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 6.961 ug/24 hour | Standard Deviation 3.8113 |
| GROUP 1: Continue Smoking | Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -0.153 ug/24 hour | Standard Deviation 2.0043 |
| GROUP 1: Continue Smoking | Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 6.808 ug/24 hour | Standard Deviation 3.6133 |
| GROUP 2: OTDN Product 1 | Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 4.792 ug/24 hour | Standard Deviation 3.4372 |
| GROUP 2: OTDN Product 1 | Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -3.283 ug/24 hour | Standard Deviation 2.7294 |
| GROUP 2: OTDN Product 1 | Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 8.075 ug/24 hour | Standard Deviation 5.6048 |
| GROUP 2: OTDN Product 1 | Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -3.379 ug/24 hour | Standard Deviation 3.1614 |
| GROUP 2: OTDN Product 1 | Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 4.820 ug/24 hour | Standard Deviation 3.0674 |
| GROUP 3: OTDN Product 2 | Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 5.559 ug/24 hour | Standard Deviation 3.9536 |
| GROUP 3: OTDN Product 2 | Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -3.518 ug/24 hour | Standard Deviation 4.0242 |
| GROUP 3: OTDN Product 2 | Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -3.719 ug/24 hour | Standard Deviation 3.6616 |
| GROUP 3: OTDN Product 2 | Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 5.358 ug/24 hour | Standard Deviation 3.7852 |
| GROUP 3: OTDN Product 2 | Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 9.077 ug/24 hour | Standard Deviation 5.8678 |
| GROUP 4: OTDN Product 1 | Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 0.482 ug/24 hour | Standard Deviation 0.4835 |
| GROUP 4: OTDN Product 1 | Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 8.540 ug/24 hour | Standard Deviation 5.0936 |
| GROUP 4: OTDN Product 1 | Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 0.557 ug/24 hour | Standard Deviation 0.5157 |
| GROUP 4: OTDN Product 1 | Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -7.984 ug/24 hour | Standard Deviation 4.9245 |
| GROUP 4: OTDN Product 1 | Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -7.948 ug/24 hour | Standard Deviation 5.0623 |
| GROUP 5: OTDN Product 2 | Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -6.165 ug/24 hour | Standard Deviation 3.6217 |
| GROUP 5: OTDN Product 2 | Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 6.542 ug/24 hour | Standard Deviation 3.7377 |
| GROUP 5: OTDN Product 2 | Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -6.382 ug/24 hour | Standard Deviation 3.6273 |
| GROUP 5: OTDN Product 2 | Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 0.377 ug/24 hour | Standard Deviation 0.1812 |
| GROUP 5: OTDN Product 2 | Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 0.319 ug/24 hour | Standard Deviation 0.13 |
| GROUP 6: Tobacco Cessation | Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day -1 | 6.756 ug/24 hour | Standard Deviation 5.0746 |
| GROUP 6: Tobacco Cessation | Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -6.246 ug/24 hour | Standard Deviation 4.8651 |
| GROUP 6: Tobacco Cessation | Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 5 | 0.511 ug/24 hour | Standard Deviation 0.3146 |
| GROUP 6: Tobacco Cessation | Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -6.239 ug/24 hour | Standard Deviation 4.9976 |
| GROUP 6: Tobacco Cessation | Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) | Day 7 | 0.458 ug/24 hour | Standard Deviation 0.2561 |
Comparison: Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [1.639, 1.971]Mixed Models Analysis
Comparison: Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [1.622, 1.954]Mixed Models Analysis
Comparison: Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [1.145, 1.462]Mixed Models Analysis
Comparison: Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [1.134, 1.447]Mixed Models Analysis
Comparison: Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [1.194, 1.513]Mixed Models Analysis
Comparison: Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [1.153, 1.472]Mixed Models Analysis
Comparison: Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [-1.155, -0.756]Mixed Models Analysis
Comparison: Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [-1.315, -0.913]Mixed Models Analysis
Comparison: Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [-1.195, -0.803]Mixed Models Analysis
Comparison: Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [-1.364, -0.964]Mixed Models Analysis
Comparison: Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [-0.969, -0.582]Mixed Models Analysis
Comparison: Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [-0.99, -0.6]Mixed Models Analysis
Comparison: Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: 0.000295% CI: [-0.836, -0.193]Mixed Models Analysis
Comparison: Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: 0.000595% CI: [-0.808, -0.16]Mixed Models Analysis
Comparison: Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: 0.001495% CI: [-0.775, -0.128]Mixed Models Analysis
Comparison: Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: 0.000795% CI: [-0.799, -0.152]Mixed Models Analysis
Comparison: Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: <0.000195% CI: [-3.127, -2.394]Mixed Models Analysis
Comparison: Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-3.271, -2.533]Mixed Models Analysis
Comparison: Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: <0.000195% CI: [-3.165, -2.443]Mixed Models Analysis
Comparison: Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-3.317, -2.587]Mixed Models Analysis
Comparison: Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: <0.000195% CI: [1.719, 2.413]Mixed Models Analysis
Comparison: Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: <0.000195% CI: [1.748, 2.449]Mixed Models Analysis
Comparison: Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: <0.000195% CI: [1.779, 2.478]Mixed Models Analysis
Comparison: Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: <0.000195% CI: [1.756, 2.459]Mixed Models Analysis
Comparison: Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 0.767895% CI: [-0.569, 0.209]Mixed Models Analysis
Comparison: Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 0.169195% CI: [-0.711, 0.073]Mixed Models Analysis
Comparison: Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 0.517895% CI: [-0.606, 0.158]Mixed Models Analysis
Comparison: Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 0.069995% CI: [-0.757, 0.018]Mixed Models Analysis
Secondary
Summary of S-PMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Summary of S-phenyl mercapturic acid (S-PMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.02 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %
Time frame: Day 5 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of S-PMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | 0.414 percentage of change | Standard Deviation 27.7146 |
| GROUP 1: Continue Smoking | Summary of S-PMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -0.440 percentage of change | Standard Deviation 27.6623 |
| GROUP 2: OTDN Product 1 | Summary of S-PMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -39.223 percentage of change | Standard Deviation 16.7927 |
| GROUP 2: OTDN Product 1 | Summary of S-PMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -37.688 percentage of change | Standard Deviation 15.2518 |
| GROUP 3: OTDN Product 2 | Summary of S-PMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -32.680 percentage of change | Standard Deviation 44.7678 |
| GROUP 3: OTDN Product 2 | Summary of S-PMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -36.710 percentage of change | Standard Deviation 33.5234 |
| GROUP 4: OTDN Product 1 | Summary of S-PMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -92.361 percentage of change | Standard Deviation 5.6169 |
| GROUP 4: OTDN Product 1 | Summary of S-PMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -92.651 percentage of change | Standard Deviation 7.7763 |
| GROUP 5: OTDN Product 2 | Summary of S-PMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -92.666 percentage of change | Standard Deviation 5.576 |
| GROUP 5: OTDN Product 2 | Summary of S-PMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -93.659 percentage of change | Standard Deviation 5.2551 |
| GROUP 6: Tobacco Cessation | Summary of S-PMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -89.785 percentage of change | Standard Deviation 7.9606 |
| GROUP 6: Tobacco Cessation | Summary of S-PMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -90.037 percentage of change | Standard Deviation 8.0553 |
Secondary
Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population)
Summary of total duration (minutes) of VERVE® product per day by Study Group and Study Day. Only study groups that received the test product (VERVE® Discs or VERVE® Chews) are shown. Results are stratified by product flavor (Green Mint, Blue Mint and overall).
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 3 | 58.9 minutes | Standard Deviation 45.94 |
| GROUP 1: Continue Smoking | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 7 | 55.2 minutes | Standard Deviation 40.88 |
| GROUP 1: Continue Smoking | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 5 | 55.5 minutes | Standard Deviation 40.23 |
| GROUP 1: Continue Smoking | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 4 | 53.3 minutes | Standard Deviation 50.87 |
| GROUP 1: Continue Smoking | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 1 | 66.6 minutes | Standard Deviation 60.86 |
| GROUP 1: Continue Smoking | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 2 | 55.4 minutes | Standard Deviation 43.38 |
| GROUP 1: Continue Smoking | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 6 | 51.9 minutes | Standard Deviation 32.63 |
| GROUP 2: OTDN Product 1 | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 3 | 70.4 minutes | Standard Deviation 77.83 |
| GROUP 2: OTDN Product 1 | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 7 | 75.7 minutes | Standard Deviation 62.68 |
| GROUP 2: OTDN Product 1 | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 6 | 62.2 minutes | Standard Deviation 55.51 |
| GROUP 2: OTDN Product 1 | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 2 | 75.0 minutes | Standard Deviation 65.29 |
| GROUP 2: OTDN Product 1 | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 5 | 70.5 minutes | Standard Deviation 71.71 |
| GROUP 2: OTDN Product 1 | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 1 | 53.3 minutes | Standard Deviation 35.94 |
| GROUP 2: OTDN Product 1 | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 4 | 56.4 minutes | Standard Deviation 50.96 |
| GROUP 3: OTDN Product 2 | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 7 | 82.5 minutes | Standard Deviation 63.51 |
| GROUP 3: OTDN Product 2 | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 4 | 78.7 minutes | Standard Deviation 60.02 |
| GROUP 3: OTDN Product 2 | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 2 | 106.1 minutes | Standard Deviation 93.4 |
| GROUP 3: OTDN Product 2 | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 6 | 82.7 minutes | Standard Deviation 58.15 |
| GROUP 3: OTDN Product 2 | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 5 | 87.8 minutes | Standard Deviation 76.8 |
| GROUP 3: OTDN Product 2 | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 1 | 96.4 minutes | Standard Deviation 73.3 |
| GROUP 3: OTDN Product 2 | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 3 | 95.8 minutes | Standard Deviation 85.57 |
| GROUP 4: OTDN Product 1 | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 5 | 52.0 minutes | Standard Deviation 51.65 |
| GROUP 4: OTDN Product 1 | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 2 | 54.4 minutes | Standard Deviation 64.55 |
| GROUP 4: OTDN Product 1 | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 7 | 60.9 minutes | Standard Deviation 46.53 |
| GROUP 4: OTDN Product 1 | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 3 | 55.8 minutes | Standard Deviation 47.73 |
| GROUP 4: OTDN Product 1 | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 6 | 57.4 minutes | Standard Deviation 56.87 |
| GROUP 4: OTDN Product 1 | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 4 | 59.2 minutes | Standard Deviation 65.29 |
| GROUP 4: OTDN Product 1 | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 1 | 62.8 minutes | Standard Deviation 57.27 |
| GROUP 5: OTDN Product 2 | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 4 | 51.8 minutes | Standard Deviation 36.46 |
| GROUP 5: OTDN Product 2 | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 1 | 43.3 minutes | Standard Deviation 28.82 |
| GROUP 5: OTDN Product 2 | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 2 | 45.0 minutes | Standard Deviation 20.73 |
| GROUP 5: OTDN Product 2 | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 3 | 53.7 minutes | Standard Deviation 28.27 |
| GROUP 5: OTDN Product 2 | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 5 | 52.9 minutes | Standard Deviation 48.87 |
| GROUP 5: OTDN Product 2 | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 6 | 60.3 minutes | Standard Deviation 50.07 |
| GROUP 5: OTDN Product 2 | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 7 | 73.8 minutes | Standard Deviation 71.37 |
| GROUP 6: Tobacco Cessation | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 2 | 75.8 minutes | Standard Deviation 59.77 |
| GROUP 6: Tobacco Cessation | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 4 | 76.1 minutes | Standard Deviation 62.69 |
| GROUP 6: Tobacco Cessation | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 7 | 76.3 minutes | Standard Deviation 77.57 |
| GROUP 6: Tobacco Cessation | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 6 | 74.8 minutes | Standard Deviation 60.34 |
| GROUP 6: Tobacco Cessation | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 5 | 74.8 minutes | Standard Deviation 58.45 |
| GROUP 6: Tobacco Cessation | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 3 | 81.2 minutes | Standard Deviation 57.39 |
| GROUP 6: Tobacco Cessation | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 1 | 87.0 minutes | Standard Deviation 59.79 |
| GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 1 | 157.8 minutes | Standard Deviation 128.82 |
| GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 2 | 136.1 minutes | Standard Deviation 123.65 |
| GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 3 | 143.3 minutes | Standard Deviation 155.53 |
| GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 5 | 143.7 minutes | Standard Deviation 160.99 |
| GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 4 | 147.1 minutes | Standard Deviation 151.6 |
| GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 6 | 148.0 minutes | Standard Deviation 182.96 |
| GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 7 | 164.3 minutes | Standard Deviation 170.36 |
| GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 1 | 68.2 minutes | Standard Deviation 69.75 |
| GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 6 | 114.1 minutes | Standard Deviation 115.23 |
| GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 4 | 107.4 minutes | Standard Deviation 107.71 |
| GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 3 | 94.8 minutes | Standard Deviation 124.33 |
| GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 7 | 92.2 minutes | Standard Deviation 121.7 |
| GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 2 | 106.6 minutes | Standard Deviation 127.33 |
| GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 5 | 122.5 minutes | Standard Deviation 96.15 |
| GROUP 4: OTDN Product 1 (VERVE® Discs Total) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 2 | 167.1 minutes | Standard Deviation 133.55 |
| GROUP 4: OTDN Product 1 (VERVE® Discs Total) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 1 | 181.8 minutes | Standard Deviation 124.4 |
| GROUP 4: OTDN Product 1 (VERVE® Discs Total) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 5 | 160.9 minutes | Standard Deviation 163.65 |
| GROUP 4: OTDN Product 1 (VERVE® Discs Total) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 3 | 165.8 minutes | Standard Deviation 157.13 |
| GROUP 4: OTDN Product 1 (VERVE® Discs Total) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 6 | 166.3 minutes | Standard Deviation 176.75 |
| GROUP 4: OTDN Product 1 (VERVE® Discs Total) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 7 | 167.4 minutes | Standard Deviation 164.72 |
| GROUP 4: OTDN Product 1 (VERVE® Discs Total) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 4 | 160.0 minutes | Standard Deviation 146.22 |
| GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 5 | 154.5 minutes | Standard Deviation 159.58 |
| GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 2 | 158.1 minutes | Standard Deviation 143.12 |
| GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 4 | 160.5 minutes | Standard Deviation 169.97 |
| GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 7 | 154.0 minutes | Standard Deviation 173.42 |
| GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 3 | 168.0 minutes | Standard Deviation 158.06 |
| GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 1 | 176.2 minutes | Standard Deviation 140.91 |
| GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 6 | 157.0 minutes | Standard Deviation 183.23 |
| GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 6 | 173.3 minutes | Standard Deviation 213.39 |
| GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 7 | 136.8 minutes | Standard Deviation 132.81 |
| GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 1 | 66.8 minutes | Standard Deviation 52.65 |
| GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 5 | 161.8 minutes | Standard Deviation 174.46 |
| GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 4 | 143.5 minutes | Standard Deviation 144.53 |
| GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 2 | 127.4 minutes | Standard Deviation 134.79 |
| GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 3 | 112.3 minutes | Standard Deviation 118.36 |
| GROUP 5: OTDN Product 2 (VERVE® Chews Total) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 1 | 190.0 minutes | Standard Deviation 150.02 |
| GROUP 5: OTDN Product 2 (VERVE® Chews Total) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 6 | 191.0 minutes | Standard Deviation 206.39 |
| GROUP 5: OTDN Product 2 (VERVE® Chews Total) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 4 | 193.0 minutes | Standard Deviation 192.4 |
| GROUP 5: OTDN Product 2 (VERVE® Chews Total) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 2 | 180.0 minutes | Standard Deviation 157.77 |
| GROUP 5: OTDN Product 2 (VERVE® Chews Total) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 5 | 191.8 minutes | Standard Deviation 185.32 |
| GROUP 5: OTDN Product 2 (VERVE® Chews Total) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 3 | 183.9 minutes | Standard Deviation 161.66 |
| GROUP 5: OTDN Product 2 (VERVE® Chews Total) | Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) | Day 7 | 182.8 minutes | Standard Deviation 178.99 |
Secondary
Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population)
Summary of urine mutagenicity (revertants/24 hours) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Baseline = Day -1. 250 mL urine sample will be concentrated to 1 mL and used for urine mutagenicity testing. The measurement results will be reported as revertants/μL. The urine mutagenicity count in the 24 hour urine will be calculated as: Urine mutagenicity (revertants/24 hour) = Urine mutagenicity (revertants/250 mL) x urine volume/ urine sample volume in mL Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Time frame: Baseline (Day -1), Day 5 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population) | Day 5 | 39814.0 revertants/24 hours | Standard Deviation 33030.58 |
| GROUP 1: Continue Smoking | Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -2687.6 revertants/24 hours | Standard Deviation 24781.58 |
| GROUP 1: Continue Smoking | Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population) | Day 7 | 40008.3 revertants/24 hours | Standard Deviation 32211.76 |
| GROUP 1: Continue Smoking | Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -2881.9 revertants/24 hours | Standard Deviation 19517.06 |
| GROUP 1: Continue Smoking | Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population) | Day -1 | 42695.9 revertants/24 hours | Standard Deviation 31628.41 |
| GROUP 2: OTDN Product 1 | Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -20856.2 revertants/24 hours | Standard Deviation 22171.89 |
| GROUP 2: OTDN Product 1 | Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -17841.2 revertants/24 hours | Standard Deviation 21897.4 |
| GROUP 2: OTDN Product 1 | Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population) | Day -1 | 40627.1 revertants/24 hours | Standard Deviation 24929.42 |
| GROUP 2: OTDN Product 1 | Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population) | Day 7 | 21884.6 revertants/24 hours | Standard Deviation 13846.21 |
| GROUP 2: OTDN Product 1 | Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population) | Day 5 | 21489.1 revertants/24 hours | Standard Deviation 15437.94 |
| GROUP 3: OTDN Product 2 | Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -12807.9 revertants/24 hours | Standard Deviation 16642.34 |
| GROUP 3: OTDN Product 2 | Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -8149.7 revertants/24 hours | Standard Deviation 14961.88 |
| GROUP 3: OTDN Product 2 | Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population) | Day -1 | 31725.0 revertants/24 hours | Standard Deviation 22029.85 |
| GROUP 3: OTDN Product 2 | Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population) | Day 5 | 18917.1 revertants/24 hours | Standard Deviation 11973.55 |
| GROUP 3: OTDN Product 2 | Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population) | Day 7 | 23575.3 revertants/24 hours | Standard Deviation 16787.62 |
| GROUP 4: OTDN Product 1 | Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population) | Day -1 | 38042.0 revertants/24 hours | Standard Deviation 25874.21 |
| GROUP 4: OTDN Product 1 | Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population) | Day 5 | 3222.7 revertants/24 hours | Standard Deviation 4029.83 |
| GROUP 4: OTDN Product 1 | Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -33209.8 revertants/24 hours | Standard Deviation 25485.69 |
| GROUP 4: OTDN Product 1 | Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -34819.4 revertants/24 hours | Standard Deviation 24457.34 |
| GROUP 4: OTDN Product 1 | Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population) | Day 7 | 5231.0 revertants/24 hours | Standard Deviation 6316.63 |
| GROUP 5: OTDN Product 2 | Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population) | Day 5 | 2450.8 revertants/24 hours | Standard Deviation 3355.41 |
| GROUP 5: OTDN Product 2 | Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -36626.8 revertants/24 hours | Standard Deviation 25513.32 |
| GROUP 5: OTDN Product 2 | Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population) | Day -1 | 39185.5 revertants/24 hours | Standard Deviation 23427.24 |
| GROUP 5: OTDN Product 2 | Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population) | Day 7 | 2962.7 revertants/24 hours | Standard Deviation 4112.19 |
| GROUP 5: OTDN Product 2 | Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -36734.7 revertants/24 hours | Standard Deviation 22541.48 |
| GROUP 6: Tobacco Cessation | Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population) | Day 7 | 4642.7 revertants/24 hours | Standard Deviation 6147.86 |
| GROUP 6: Tobacco Cessation | Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -42147.8 revertants/24 hours | Standard Deviation 23806.81 |
| GROUP 6: Tobacco Cessation | Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -41002.6 revertants/24 hours | Standard Deviation 24082.18 |
| GROUP 6: Tobacco Cessation | Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population) | Day 5 | 3051.1 revertants/24 hours | Standard Deviation 3011.89 |
| GROUP 6: Tobacco Cessation | Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population) | Day -1 | 45475.7 revertants/24 hours | Standard Deviation 24556.04 |
Comparison: Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [164.9, 195.2]Mixed Models Analysis
Comparison: Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [165.9, 196.2]Mixed Models Analysis
Comparison: Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [117.2, 147.5]Mixed Models Analysis
Comparison: Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [122.1, 152.5]Mixed Models Analysis
Comparison: Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [122, 151.7]Mixed Models Analysis
Comparison: Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [136, 165.7]Mixed Models Analysis
Comparison: Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [25.1, 61.4]Mixed Models Analysis
Comparison: Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [43.2, 80.1]Mixed Models Analysis
Comparison: Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [18.6, 55.1]Mixed Models Analysis
Comparison: Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to zero on Day 7. (mITT Population)p-value: 0.000295% CI: [16.7, 54.3]Mixed Models Analysis
Comparison: Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [19.9, 57.6]Mixed Models Analysis
Comparison: Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [26, 63.8]Mixed Models Analysis
Comparison: Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: 0.000295% CI: [-78, -17.4]Mixed Models Analysis
Comparison: Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: 0.000995% CI: [-74.1, -13.4]Mixed Models Analysis
Comparison: Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: 0.000995% CI: [-73.2, -13.3]Mixed Models Analysis
Comparison: Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: 0.046695% CI: [-60.2, -0.3]Mixed Models Analysis
Comparison: Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: <0.000195% CI: [-170.4, -103.3]Mixed Models Analysis
Comparison: Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-153.3, -85.5]Mixed Models Analysis
Comparison: Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: <0.000195% CI: [-176.6, -109.7]Mixed Models Analysis
Comparison: Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-179.7, -111.4]Mixed Models Analysis
Comparison: Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: <0.000195% CI: [60, 127.2]Mixed Models Analysis
Comparison: Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: <0.000195% CI: [58.8, 126.1]Mixed Models Analysis
Comparison: Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: <0.000195% CI: [64.6, 131.5]Mixed Models Analysis
Comparison: Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: <0.000195% CI: [72.5, 139.4]Mixed Models Analysis
Comparison: Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 195% CI: [-32, 40.9]Mixed Models Analysis
Comparison: Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 0.771495% CI: [-20, 53.5]Mixed Models Analysis
Comparison: Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 195% CI: [-38.3, 34.5]Mixed Models Analysis
Comparison: Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 0.992695% CI: [-46.4, 27.6]Mixed Models Analysis
Secondary
Summary of Urine Mutagenicity Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Summary of urine mutagenicity percent change from Baseline (%) by study group and study day is presented. Baseline = Day -1. 250 mL urine sample will be concentrated to 1 mL and used for urine mutagenicity testing. The measurement results will be reported as revertants/μL. The urine mutagenicity count in the 24 hour urine will be calculated as: Urine mutagenicity (revertants/24 hour) = Urine mutagenicity (revertants/250 mL) x urine volume/ urine sample volume in mL % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %
Time frame: Day 5 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of Urine Mutagenicity Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | 6.059 percentage of change | Standard Deviation 60.6504 |
| GROUP 1: Continue Smoking | Summary of Urine Mutagenicity Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | 7.844 percentage of change | Standard Deviation 62.4696 |
| GROUP 2: OTDN Product 1 | Summary of Urine Mutagenicity Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -40.200 percentage of change | Standard Deviation 37.5319 |
| GROUP 2: OTDN Product 1 | Summary of Urine Mutagenicity Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -26.765 percentage of change | Standard Deviation 75.6831 |
| GROUP 3: OTDN Product 2 | Summary of Urine Mutagenicity Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -27.954 percentage of change | Standard Deviation 45.8289 |
| GROUP 3: OTDN Product 2 | Summary of Urine Mutagenicity Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -14.729 percentage of change | Standard Deviation 60.1017 |
| GROUP 4: OTDN Product 1 | Summary of Urine Mutagenicity Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -91.239 percentage of change | Standard Deviation 9.0409 |
| GROUP 4: OTDN Product 1 | Summary of Urine Mutagenicity Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -84.415 percentage of change | Standard Deviation 16.2799 |
| GROUP 5: OTDN Product 2 | Summary of Urine Mutagenicity Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -93.056 percentage of change | Standard Deviation 7.6922 |
| GROUP 5: OTDN Product 2 | Summary of Urine Mutagenicity Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -87.632 percentage of change | Standard Deviation 25.0981 |
| GROUP 6: Tobacco Cessation | Summary of Urine Mutagenicity Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -91.057 percentage of change | Standard Deviation 9.3363 |
| GROUP 6: Tobacco Cessation | Summary of Urine Mutagenicity Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -88.904 percentage of change | Standard Deviation 11.3419 |
Secondary
Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population)
Summary of VERVE® Product Used Per Day by Study Group and Study Day is presented. Only study groups that received the test product (VERVE® Discs or VERVE® Chews) are shown. Results are stratified by product flavor (Green Mint, Blue Mint and overall).
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 2 | 3.6 products per day | Standard Deviation 2.02 |
| GROUP 1: Continue Smoking | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 6 | 4.0 products per day | Standard Deviation 2.3 |
| GROUP 1: Continue Smoking | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 3 | 3.9 products per day | Standard Deviation 2.05 |
| GROUP 1: Continue Smoking | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 1 | 4.2 products per day | Standard Deviation 2.41 |
| GROUP 1: Continue Smoking | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 7 | 3.8 products per day | Standard Deviation 1.99 |
| GROUP 1: Continue Smoking | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 4 | 3.9 products per day | Standard Deviation 2.35 |
| GROUP 1: Continue Smoking | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 5 | 3.3 products per day | Standard Deviation 2.1 |
| GROUP 2: OTDN Product 1 | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 6 | 3.6 products per day | Standard Deviation 2.3 |
| GROUP 2: OTDN Product 1 | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 3 | 3.7 products per day | Standard Deviation 1.76 |
| GROUP 2: OTDN Product 1 | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 5 | 3.6 products per day | Standard Deviation 1.72 |
| GROUP 2: OTDN Product 1 | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 1 | 3.5 products per day | Standard Deviation 2.73 |
| GROUP 2: OTDN Product 1 | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 7 | 4.0 products per day | Standard Deviation 2.44 |
| GROUP 2: OTDN Product 1 | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 2 | 4.2 products per day | Standard Deviation 2.17 |
| GROUP 2: OTDN Product 1 | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 4 | 3.6 products per day | Standard Deviation 2.32 |
| GROUP 3: OTDN Product 2 | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 7 | 5.4 products per day | Standard Deviation 3.04 |
| GROUP 3: OTDN Product 2 | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 3 | 6.0 products per day | Standard Deviation 2.77 |
| GROUP 3: OTDN Product 2 | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 2 | 6.5 products per day | Standard Deviation 2.96 |
| GROUP 3: OTDN Product 2 | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 1 | 6.3 products per day | Standard Deviation 3.74 |
| GROUP 3: OTDN Product 2 | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 5 | 5.4 products per day | Standard Deviation 2.34 |
| GROUP 3: OTDN Product 2 | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 4 | 5.8 products per day | Standard Deviation 3.14 |
| GROUP 3: OTDN Product 2 | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 6 | 5.8 products per day | Standard Deviation 2.73 |
| GROUP 4: OTDN Product 1 | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 5 | 3.5 products per day | Standard Deviation 1.87 |
| GROUP 4: OTDN Product 1 | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 7 | 4.4 products per day | Standard Deviation 2.38 |
| GROUP 4: OTDN Product 1 | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 1 | 3.9 products per day | Standard Deviation 2.31 |
| GROUP 4: OTDN Product 1 | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 3 | 3.6 products per day | Standard Deviation 2.13 |
| GROUP 4: OTDN Product 1 | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 4 | 3.7 products per day | Standard Deviation 2.76 |
| GROUP 4: OTDN Product 1 | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 2 | 3.3 products per day | Standard Deviation 1.95 |
| GROUP 4: OTDN Product 1 | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 6 | 3.9 products per day | Standard Deviation 2.78 |
| GROUP 5: OTDN Product 2 | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 5 | 3.5 products per day | Standard Deviation 1.67 |
| GROUP 5: OTDN Product 2 | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 1 | 3.0 products per day | Standard Deviation 1.74 |
| GROUP 5: OTDN Product 2 | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 2 | 3.4 products per day | Standard Deviation 1.42 |
| GROUP 5: OTDN Product 2 | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 3 | 3.5 products per day | Standard Deviation 1.38 |
| GROUP 5: OTDN Product 2 | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 4 | 3.9 products per day | Standard Deviation 2.08 |
| GROUP 5: OTDN Product 2 | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 6 | 4.4 products per day | Standard Deviation 2.75 |
| GROUP 5: OTDN Product 2 | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 7 | 4.6 products per day | Standard Deviation 2.99 |
| GROUP 6: Tobacco Cessation | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 5 | 5.7 products per day | Standard Deviation 2.82 |
| GROUP 6: Tobacco Cessation | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 4 | 5.6 products per day | Standard Deviation 3.15 |
| GROUP 6: Tobacco Cessation | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 2 | 5.2 products per day | Standard Deviation 2.36 |
| GROUP 6: Tobacco Cessation | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 7 | 6.1 products per day | Standard Deviation 4.81 |
| GROUP 6: Tobacco Cessation | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 3 | 5.6 products per day | Standard Deviation 2.76 |
| GROUP 6: Tobacco Cessation | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 1 | 5.8 products per day | Standard Deviation 2.78 |
| GROUP 6: Tobacco Cessation | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 6 | 6.2 products per day | Standard Deviation 4.5 |
| GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 1 | 8.9 products per day | Standard Deviation 6.29 |
| GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 2 | 8.2 products per day | Standard Deviation 6.37 |
| GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 5 | 7.9 products per day | Standard Deviation 7.15 |
| GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 7 | 8.1 products per day | Standard Deviation 5.41 |
| GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 3 | 7.8 products per day | Standard Deviation 5.64 |
| GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 4 | 8.3 products per day | Standard Deviation 6.98 |
| GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 6 | 6.9 products per day | Standard Deviation 5.89 |
| GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 5 | 10.7 products per day | Standard Deviation 10.26 |
| GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 6 | 9.9 products per day | Standard Deviation 9.83 |
| GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 3 | 7.7 products per day | Standard Deviation 9.61 |
| GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 2 | 6.9 products per day | Standard Deviation 8.76 |
| GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 4 | 8.7 products per day | Standard Deviation 8.7 |
| GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 7 | 6.2 products per day | Standard Deviation 3.93 |
| GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 1 | 4.8 products per day | Standard Deviation 6.41 |
| GROUP 4: OTDN Product 1 (VERVE® Discs Total) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 3 | 11.0 products per day | Standard Deviation 9.61 |
| GROUP 4: OTDN Product 1 (VERVE® Discs Total) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 2 | 11.6 products per day | Standard Deviation 8.6 |
| GROUP 4: OTDN Product 1 (VERVE® Discs Total) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 4 | 10.8 products per day | Standard Deviation 9.22 |
| GROUP 4: OTDN Product 1 (VERVE® Discs Total) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 5 | 11.5 products per day | Standard Deviation 11.13 |
| GROUP 4: OTDN Product 1 (VERVE® Discs Total) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 1 | 11.5 products per day | Standard Deviation 8.87 |
| GROUP 4: OTDN Product 1 (VERVE® Discs Total) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 6 | 10.1 products per day | Standard Deviation 9.42 |
| GROUP 4: OTDN Product 1 (VERVE® Discs Total) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 7 | 10.2 products per day | Standard Deviation 7 |
| GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 3 | 8.2 products per day | Standard Deviation 5.75 |
| GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 5 | 7.1 products per day | Standard Deviation 5.17 |
| GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 6 | 6.0 products per day | Standard Deviation 4.31 |
| GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 4 | 7.0 products per day | Standard Deviation 4.73 |
| GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 7 | 6.7 products per day | Standard Deviation 4.99 |
| GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 2 | 7.7 products per day | Standard Deviation 5.35 |
| GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 1 | 9.0 products per day | Standard Deviation 5.88 |
| GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 6 | 6.2 products per day | Standard Deviation 5.1 |
| GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 4 | 6.5 products per day | Standard Deviation 4.79 |
| GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 1 | 4.5 products per day | Standard Deviation 3.79 |
| GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 7 | 5.3 products per day | Standard Deviation 4.65 |
| GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 5 | 6.5 products per day | Standard Deviation 4.84 |
| GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 2 | 6.9 products per day | Standard Deviation 4.87 |
| GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 3 | 6.0 products per day | Standard Deviation 4.46 |
| GROUP 5: OTDN Product 2 (VERVE® Chews Total) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 5 | 9.4 products per day | Standard Deviation 7.33 |
| GROUP 5: OTDN Product 2 (VERVE® Chews Total) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 6 | 8.5 products per day | Standard Deviation 5.92 |
| GROUP 5: OTDN Product 2 (VERVE® Chews Total) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 4 | 9.7 products per day | Standard Deviation 6.93 |
| GROUP 5: OTDN Product 2 (VERVE® Chews Total) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 3 | 10.2 products per day | Standard Deviation 7.03 |
| GROUP 5: OTDN Product 2 (VERVE® Chews Total) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 2 | 10.4 products per day | Standard Deviation 7.71 |
| GROUP 5: OTDN Product 2 (VERVE® Chews Total) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 1 | 10.9 products per day | Standard Deviation 7.38 |
| GROUP 5: OTDN Product 2 (VERVE® Chews Total) | Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) | Day 7 | 8.8 products per day | Standard Deviation 6.08 |
Secondary
Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population)
Summary of average VERVE® product use duration (minutes) by Study Group and Study Day is presented. Only study groups that received the test product (VERVE® Discs or VERVE® Chews) are shown. Results are stratified by product flavor (Green Mint, Blue Mint and overall).
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 6 | 17.87 minutes | Standard Deviation 11.063 |
| GROUP 1: Continue Smoking | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 5 | 21.38 minutes | Standard Deviation 13.978 |
| GROUP 1: Continue Smoking | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 3 | 17.83 minutes | Standard Deviation 11.425 |
| GROUP 1: Continue Smoking | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 1 | 16.91 minutes | Standard Deviation 9.058 |
| GROUP 1: Continue Smoking | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 4 | 15.78 minutes | Standard Deviation 7.87 |
| GROUP 1: Continue Smoking | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 2 | 17.77 minutes | Standard Deviation 12.379 |
| GROUP 1: Continue Smoking | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 7 | 20.48 minutes | Standard Deviation 21.835 |
| GROUP 2: OTDN Product 1 | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 2 | 20.10 minutes | Standard Deviation 10.256 |
| GROUP 2: OTDN Product 1 | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 4 | 19.65 minutes | Standard Deviation 9.81 |
| GROUP 2: OTDN Product 1 | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 1 | 19.06 minutes | Standard Deviation 7.981 |
| GROUP 2: OTDN Product 1 | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 6 | 23.23 minutes | Standard Deviation 14.472 |
| GROUP 2: OTDN Product 1 | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 3 | 19.40 minutes | Standard Deviation 13.169 |
| GROUP 2: OTDN Product 1 | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 7 | 23.28 minutes | Standard Deviation 14.382 |
| GROUP 2: OTDN Product 1 | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 5 | 23.22 minutes | Standard Deviation 14.124 |
| GROUP 3: OTDN Product 2 | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 7 | 19.92 minutes | Standard Deviation 12.807 |
| GROUP 3: OTDN Product 2 | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 5 | 20.20 minutes | Standard Deviation 11.398 |
| GROUP 3: OTDN Product 2 | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 2 | 18.03 minutes | Standard Deviation 8.374 |
| GROUP 3: OTDN Product 2 | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 1 | 17.37 minutes | Standard Deviation 7.486 |
| GROUP 3: OTDN Product 2 | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 6 | 18.77 minutes | Standard Deviation 9.691 |
| GROUP 3: OTDN Product 2 | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 3 | 18.43 minutes | Standard Deviation 11.026 |
| GROUP 3: OTDN Product 2 | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 4 | 16.73 minutes | Standard Deviation 7.42 |
| GROUP 4: OTDN Product 1 | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 4 | 18.63 minutes | Standard Deviation 14.374 |
| GROUP 4: OTDN Product 1 | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 5 | 17.67 minutes | Standard Deviation 10.156 |
| GROUP 4: OTDN Product 1 | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 1 | 16.81 minutes | Standard Deviation 7.429 |
| GROUP 4: OTDN Product 1 | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 2 | 16.17 minutes | Standard Deviation 8.43 |
| GROUP 4: OTDN Product 1 | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 7 | 17.48 minutes | Standard Deviation 11.218 |
| GROUP 4: OTDN Product 1 | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 6 | 16.45 minutes | Standard Deviation 8.468 |
| GROUP 4: OTDN Product 1 | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 3 | 17.52 minutes | Standard Deviation 10.282 |
| GROUP 5: OTDN Product 2 | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 6 | 16.94 minutes | Standard Deviation 5.422 |
| GROUP 5: OTDN Product 2 | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 4 | 15.56 minutes | Standard Deviation 5.719 |
| GROUP 5: OTDN Product 2 | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 3 | 18.10 minutes | Standard Deviation 7.953 |
| GROUP 5: OTDN Product 2 | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 7 | 18.20 minutes | Standard Deviation 11.249 |
| GROUP 5: OTDN Product 2 | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 5 | 16.96 minutes | Standard Deviation 8.84 |
| GROUP 5: OTDN Product 2 | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 1 | 15.40 minutes | Standard Deviation 4.389 |
| GROUP 5: OTDN Product 2 | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 2 | 15.46 minutes | Standard Deviation 4.755 |
| GROUP 6: Tobacco Cessation | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 3 | 17.66 minutes | Standard Deviation 8.972 |
| GROUP 6: Tobacco Cessation | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 1 | 16.38 minutes | Standard Deviation 6.312 |
| GROUP 6: Tobacco Cessation | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 6 | 16.77 minutes | Standard Deviation 6.913 |
| GROUP 6: Tobacco Cessation | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 2 | 16.41 minutes | Standard Deviation 7.557 |
| GROUP 6: Tobacco Cessation | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 7 | 16.31 minutes | Standard Deviation 8.677 |
| GROUP 6: Tobacco Cessation | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 5 | 17.48 minutes | Standard Deviation 10.334 |
| GROUP 6: Tobacco Cessation | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 4 | 17.42 minutes | Standard Deviation 11.163 |
| GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 4 | 23.67 minutes | Standard Deviation 16.357 |
| GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 1 | 21.04 minutes | Standard Deviation 12.43 |
| GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 2 | 19.75 minutes | Standard Deviation 12.736 |
| GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 3 | 22.19 minutes | Standard Deviation 14.651 |
| GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 5 | 22.81 minutes | Standard Deviation 17.683 |
| GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 6 | 24.05 minutes | Standard Deviation 19.149 |
| GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 7 | 25.74 minutes | Standard Deviation 18.642 |
| GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 6 | 17.98 minutes | Standard Deviation 12.472 |
| GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 4 | 18.55 minutes | Standard Deviation 11.495 |
| GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 7 | 16.95 minutes | Standard Deviation 10.356 |
| GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 1 | 36.07 minutes | Standard Deviation 60.238 |
| GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 5 | 21.08 minutes | Standard Deviation 14.347 |
| GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 3 | 17.35 minutes | Standard Deviation 10.42 |
| GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 2 | 24.28 minutes | Standard Deviation 18.445 |
| GROUP 4: OTDN Product 1 (VERVE® Discs Total) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 1 | 24.49 minutes | Standard Deviation 20.627 |
| GROUP 4: OTDN Product 1 (VERVE® Discs Total) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 2 | 20.67 minutes | Standard Deviation 13.519 |
| GROUP 4: OTDN Product 1 (VERVE® Discs Total) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 6 | 23.86 minutes | Standard Deviation 18.887 |
| GROUP 4: OTDN Product 1 (VERVE® Discs Total) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 4 | 23.33 minutes | Standard Deviation 15.876 |
| GROUP 4: OTDN Product 1 (VERVE® Discs Total) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 5 | 21.76 minutes | Standard Deviation 17.151 |
| GROUP 4: OTDN Product 1 (VERVE® Discs Total) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 7 | 23.94 minutes | Standard Deviation 17.928 |
| GROUP 4: OTDN Product 1 (VERVE® Discs Total) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 3 | 21.50 minutes | Standard Deviation 14.545 |
| GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 4 | 27.80 minutes | Standard Deviation 22.588 |
| GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 3 | 24.37 minutes | Standard Deviation 16.063 |
| GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 7 | 29.14 minutes | Standard Deviation 24.03 |
| GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 5 | 25.71 minutes | Standard Deviation 20.315 |
| GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 2 | 23.75 minutes | Standard Deviation 16.97 |
| GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 6 | 28.84 minutes | Standard Deviation 24.557 |
| GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 1 | 24.03 minutes | Standard Deviation 13.9 |
| GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 2 | 23.98 minutes | Standard Deviation 16.273 |
| GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 1 | 28.80 minutes | Standard Deviation 29.84 |
| GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 5 | 35.75 minutes | Standard Deviation 34.492 |
| GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 3 | 23.20 minutes | Standard Deviation 17.406 |
| GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 4 | 33.71 minutes | Standard Deviation 35.998 |
| GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 7 | 33.44 minutes | Standard Deviation 24.807 |
| GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 6 | 30.48 minutes | Standard Deviation 23.753 |
| GROUP 5: OTDN Product 2 (VERVE® Chews Total) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 4 | 26.30 minutes | Standard Deviation 22.554 |
| GROUP 5: OTDN Product 2 (VERVE® Chews Total) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 6 | 27.44 minutes | Standard Deviation 22.541 |
| GROUP 5: OTDN Product 2 (VERVE® Chews Total) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 1 | 23.40 minutes | Standard Deviation 14.369 |
| GROUP 5: OTDN Product 2 (VERVE® Chews Total) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 3 | 23.92 minutes | Standard Deviation 15.846 |
| GROUP 5: OTDN Product 2 (VERVE® Chews Total) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 2 | 23.31 minutes | Standard Deviation 15.503 |
| GROUP 5: OTDN Product 2 (VERVE® Chews Total) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 5 | 29.26 minutes | Standard Deviation 28.16 |
| GROUP 5: OTDN Product 2 (VERVE® Chews Total) | Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) | Day 7 | 28.08 minutes | Standard Deviation 23.037 |
Secondary
Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population)
Summary of whole blood carboxyhemoglobin \[COHb\] (% saturation) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Baseline = Day -1. The blood sample for COHb was collected approximately 21:30 on Days -1, 5, and 7 after subjects abstained from product use, as appropriate, for at least 15 minutes prior to blood draw for COHb. Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Time frame: Baseline (Day -1), Day 5 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -0.15 % Saturation | Standard Deviation 1.231 |
| GROUP 1: Continue Smoking | Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population) | Day 5 | 6.53 % Saturation | Standard Deviation 1.599 |
| GROUP 1: Continue Smoking | Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population) | Day -1 | 6.68 % Saturation | Standard Deviation 1.815 |
| GROUP 1: Continue Smoking | Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | 0.09 % Saturation | Standard Deviation 1.394 |
| GROUP 1: Continue Smoking | Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population) | Day 7 | 6.77 % Saturation | Standard Deviation 1.516 |
| GROUP 2: OTDN Product 1 | Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population) | Day 5 | 4.50 % Saturation | Standard Deviation 1.216 |
| GROUP 2: OTDN Product 1 | Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -2.32 % Saturation | Standard Deviation 1.328 |
| GROUP 2: OTDN Product 1 | Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population) | Day -1 | 6.81 % Saturation | Standard Deviation 1.65 |
| GROUP 2: OTDN Product 1 | Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -2.20 % Saturation | Standard Deviation 1.304 |
| GROUP 2: OTDN Product 1 | Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population) | Day 7 | 4.61 % Saturation | Standard Deviation 1.244 |
| GROUP 3: OTDN Product 2 | Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population) | Day 5 | 4.91 % Saturation | Standard Deviation 1.304 |
| GROUP 3: OTDN Product 2 | Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -2.20 % Saturation | Standard Deviation 1.251 |
| GROUP 3: OTDN Product 2 | Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -1.98 % Saturation | Standard Deviation 1.193 |
| GROUP 3: OTDN Product 2 | Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population) | Day 7 | 5.11 % Saturation | Standard Deviation 1.274 |
| GROUP 3: OTDN Product 2 | Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population) | Day -1 | 7.11 % Saturation | Standard Deviation 1.927 |
| GROUP 4: OTDN Product 1 | Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population) | Day 7 | 1.85 % Saturation | Standard Deviation 0.302 |
| GROUP 4: OTDN Product 1 | Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population) | Day -1 | 7.23 % Saturation | Standard Deviation 2.269 |
| GROUP 4: OTDN Product 1 | Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population) | Day 5 | 1.78 % Saturation | Standard Deviation 0.169 |
| GROUP 4: OTDN Product 1 | Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -5.45 % Saturation | Standard Deviation 2.253 |
| GROUP 4: OTDN Product 1 | Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -5.28 % Saturation | Standard Deviation 2.269 |
| GROUP 5: OTDN Product 2 | Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -5.25 % Saturation | Standard Deviation 1.711 |
| GROUP 5: OTDN Product 2 | Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population) | Day -1 | 6.98 % Saturation | Standard Deviation 1.711 |
| GROUP 5: OTDN Product 2 | Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -5.22 % Saturation | Standard Deviation 1.684 |
| GROUP 5: OTDN Product 2 | Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population) | Day 5 | 1.73 % Saturation | Standard Deviation 0.272 |
| GROUP 5: OTDN Product 2 | Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population) | Day 7 | 1.82 % Saturation | Standard Deviation 0.388 |
| GROUP 6: Tobacco Cessation | Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population) | Day -1 | 6.89 % Saturation | Standard Deviation 2.038 |
| GROUP 6: Tobacco Cessation | Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 5) | -5.10 % Saturation | Standard Deviation 1.903 |
| GROUP 6: Tobacco Cessation | Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population) | Day 5 | 1.79 % Saturation | Standard Deviation 0.281 |
| GROUP 6: Tobacco Cessation | Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population) | Change from Baseline (Day 7) | -5.04 % Saturation | Standard Deviation 1.893 |
| GROUP 6: Tobacco Cessation | Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population) | Day 7 | 1.79 % Saturation | Standard Deviation 0.281 |
Comparison: Null hypothesis: Whole Blood COHB (% Saturation) in Group 1 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 1 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [1.81, 1.935]Mixed Models Analysis
Comparison: Null hypothesis: Whole Blood COHB (% Saturation) in Group 1 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 1 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [1.851, 1.976]Mixed Models Analysis
Comparison: Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [1.408, 1.525]Mixed Models Analysis
Comparison: Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [1.434, 1.551]Mixed Models Analysis
Comparison: Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [1.49, 1.609]Mixed Models Analysis
Comparison: Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [1.533, 1.654]Mixed Models Analysis
Comparison: Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [0.482, 0.631]Mixed Models Analysis
Comparison: Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [0.514, 0.665]Mixed Models Analysis
Comparison: Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [0.461, 0.605]Mixed Models Analysis
Comparison: Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [0.514, 0.662]Mixed Models Analysis
Comparison: Null hypothesis: Whole Blood COHB (% Saturation) in Group 6 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 6 is NOT equal to zero on Day 5. (mITT Population)p-value: <0.000195% CI: [0.508, 0.652]Mixed Models Analysis
Comparison: Null hypothesis: Whole Blood COHB (% Saturation) in Group 6 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 6 is NOT equal to zero on Day 7. (mITT Population)p-value: <0.000195% CI: [0.507, 0.653]Mixed Models Analysis
Comparison: Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: <0.000195% CI: [-0.526, -0.285]Mixed Models Analysis
Comparison: Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-0.541, -0.3]Mixed Models Analysis
Comparison: Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: <0.000195% CI: [-0.444, -0.201]Mixed Models Analysis
Comparison: Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-0.442, -0.198]Mixed Models Analysis
Comparison: Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: <0.000195% CI: [-1.453, -1.178]Mixed Models Analysis
Comparison: Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-1.463, -1.186]Mixed Models Analysis
Comparison: Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)p-value: <0.000195% CI: [-1.473, -1.205]Mixed Models Analysis
Comparison: Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)p-value: <0.000195% CI: [-1.461, -1.19]Mixed Models Analysis
Comparison: Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: <0.000195% CI: [0.757, 1.016]Mixed Models Analysis
Comparison: Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: <0.000195% CI: [0.782, 1.043]Mixed Models Analysis
Comparison: Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: <0.000195% CI: [0.839, 1.1]Mixed Models Analysis
Comparison: Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: <0.000195% CI: [0.882, 1.145]Mixed Models Analysis
Comparison: Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 0.999995% CI: [-0.168, 0.122]Mixed Models Analysis
Comparison: Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 195% CI: [-0.138, 0.155]Mixed Models Analysis
Comparison: Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)p-value: 0.957795% CI: [-0.189, 0.095]Mixed Models Analysis
Comparison: Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)p-value: 195% CI: [-0.136, 0.152]Mixed Models Analysis
Secondary
Summary of Whole Blood COHb Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Summary of whole blood carboxyhemoglobin (COHb) percent change from Baseline (%) is presented. Subjects with valid sample results are included. Baseline = Day -1. The blood sample for COHb was collected approximately 21:30 on Days -1, 5, and 7 after subjects abstained from product use, as appropriate, for at least 15 minutes prior to blood draw for COHb. % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %
Time frame: Day 5 and Day 7
Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GROUP 1: Continue Smoking | Summary of Whole Blood COHb Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | 0.459 percentage of change | Standard Deviation 19.3191 |
| GROUP 1: Continue Smoking | Summary of Whole Blood COHb Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | 5.451 percentage of change | Standard Deviation 25.3747 |
| GROUP 2: OTDN Product 1 | Summary of Whole Blood COHb Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -32.762 percentage of change | Standard Deviation 15.6487 |
| GROUP 2: OTDN Product 1 | Summary of Whole Blood COHb Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -31.264 percentage of change | Standard Deviation 14.3934 |
| GROUP 3: OTDN Product 2 | Summary of Whole Blood COHb Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -29.807 percentage of change | Standard Deviation 11.1205 |
| GROUP 3: OTDN Product 2 | Summary of Whole Blood COHb Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -26.160 percentage of change | Standard Deviation 14.0914 |
| GROUP 4: OTDN Product 1 | Summary of Whole Blood COHb Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -73.352 percentage of change | Standard Deviation 7.5619 |
| GROUP 4: OTDN Product 1 | Summary of Whole Blood COHb Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -71.853 percentage of change | Standard Deviation 10.0793 |
| GROUP 5: OTDN Product 2 | Summary of Whole Blood COHb Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -73.827 percentage of change | Standard Deviation 7.7024 |
| GROUP 5: OTDN Product 2 | Summary of Whole Blood COHb Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -72.896 percentage of change | Standard Deviation 7.712 |
| GROUP 6: Tobacco Cessation | Summary of Whole Blood COHb Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 5 | -72.424 percentage of change | Standard Deviation 7.7658 |
| GROUP 6: Tobacco Cessation | Summary of Whole Blood COHb Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) | Day 7 | -72.391 percentage of change | Standard Deviation 6.4588 |