Smoking, Abdominal Aortic Aneurysm, IQOS Use
Conditions
Brief summary
The purpose of this study was to evaluate the reduction of the Abdominal Aortic Aneurysm (AAA) annual growth rate in patients who switched from smoking cigarettes to using IQOS as compared to patients who continued to smoke cigarettes, and to patients who had quit smoking. The study also aimed to provide context to the scale of reduction in the growth rate, by comparing the AAA annual growth rates for continuing to smoke and switching to IQOS with the AAA annual growth rate in smokers who had stopped smoking. The study further evaluated the effects of switching to IQOS on co-morbidities observed in AAA patients that are related to smoking as well as to assess the effects on relevant Biomarkers of Potential Harm (BoPH) linked to smoking related diseases.
Detailed description
This was a controlled, open-label, 3-arm parallel group, multi-center study in patients diagnosed with Abdominal Aortic Aneurysm (AAA) to evaluate the AAA annual growth rate in adult smokers randomized to either continue smoking combustible cigarettes (CC) or to switch to IQOS and in adults who had stopped smoking, as a non-randomized control arm. This was a descriptive study, designed to gain an understanding of how changes in smoking behaviors impact AAA growth rate and disease progression. Therefore, there were no formal statistical hypotheses to be tested. Smoking patients with AAA who did not quit smoking after their AAA diagnosis, and who were not intending to quit within the next 6 months were screened for enrollment and randomization in the CC and IQOS arms if all other eligibility criteria were met. Smoking patients with AAA who had completely stopped smoking and using any other tobacco or nicotine-containing products within 2 months of their AAA diagnosis, and were still abstinent at the time of the Screening Visit and of the Baseline Visit were screened to be enrolled in the smoking cessation (SC) arm without randomization.
Interventions
OTHERIQOS
AAA patients will switch from cigarette smoking to ad libitum IQOS use, with no flavor variant restrictions.
OTHERCigarette
AAA patients will continue to smoke their cigarettes ad libitum, with no brand restrictions.
OTHERSmoking Cessation
AAA patients who have completely quit smoking will continue to remain abstinent from smoking cigarettes or using any tobacco or nicotine-containing product(s)
Sponsors
Philip Morris Products S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria: * Patient diagnosed with AAA (infrarenal, fusiform type) with a current aortic maximum minor-axis diameter of 30 to ≤ 49 mm (in male patient) and 30 to ≤ 44 mm (in female patient). * Patient has smoked on a daily basis (no brand restrictions) for at least 5 years prior to AAA diagnosis, based on self-reporting * Patient is ready to comply with the study protocol (e.g., to use their assigned product/regimen during the course of the study) Inclusion criteria specific to patients screened for enrollment and randomization to the CC or IQOS arm: * Patient has smoked on average at least 5 commercially available CC per day (no brand restriction) for the last 12 months, based on self-reporting. Intermittent attempts to quit smoking not exceeding 2 months or short-term interruption of smoking up to 10 days within the last 12 months will be allowed. Smoking status will be verified based on a urinary cotinine test (i.e., cotinine ≥ 200 ng/mL). * Not intending to quit smoking within the next 6 months after having been advised to quit smoking. Inclusion Criteria specific to patients screened for enrollment into the SC arm: * Patient had completely quit smoking and stopped the use of any other tobacco or nicotine-containing products within 6 months after AAA diagnosis, and is still abstinent at Screening and at Baseline. Smoking status will be verified based on a urinary cotinine test (i.e., cotinine \< 100 ng/mL).
Exclusion criteria
* Patient is legally incompetent, physically or mentally incapable of giving consent. * Patient is a current or former employee of the tobacco industry or their first-degree relatives (parent and child); patient is an employee of the investigational site or any other parties involved in the study or their first-degree relatives (parent and child). * Patient has been previously screened or enrolled in this study or was enrolled in any clinical study within 3 months prior to the Screening Visit. * Female patient who is pregnant or breast-feeding. * Patient is ineligible as judged by the Investigator to participate in the study for any reason. * Patient with acute severe cardiovascular events or respiratory diseases, within the last 3 months; with currently active cancer or history of cancer within the last 5 years; with dissecting aneurysm(s) of the aorta; with infrarenal pseudo-AAA (false AAA); with a diagnosis of COPD Stage 3 and 4 in the medical history; with a recent (within 1 year) or current history of alcohol or other substance abuse based on self-reporting. * Patient with a diagnosis of concomitant genetic diseases such as but not limited to Marfan syndrome, Loeys-Dietz syndrome, Vascular Ehlers-Danlos syndrome, Turner syndrome, Polycystic kidney disease, Noonan syndrome, Alagile syndrome, Arterial tortuosity syndrome and Cutis laxa.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AAA Annual Growth Rate Over Time | At 6-month intervals from baseline to V8 (month 36) | AAA annual growth rate will be measured in AAA patients who switch from smoking cigarettes to using IQOS, and AAA patients who continue to smoke CC, as compared to AAA patients who had stopped smoking. Maximum minor-axis AAA diameter in mm will be measured. Annual growth rate will be calculated by annualizing the slope of the linear regression over the available diameter measurements. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Without Open Surgical AAA Treatment or AAA Rupture Over Time | From time of AAA diagnosis (prior to study participation) until V8 (month 36), a time frame of up to 7 years | This outcome measured the percentage of subjects without surgery or AAA rupture over time in AAA patients who switch from smoking CC to using IQOS, as compared to AAA patients who continue smoking CC and AAA patients who had stopped smoking. |
| Incidence of Open Surgical AAA Treatment or AAA Endovascular Repair and AAA Rupture | From baseline to V8 (month 36) | The incidence of open surgical AAA treatment or AAA endovascular repair and AAA rupture will be measured in AAA patients who switch from smoking CC to using IQOS, as compared to AAA patients who continue to smoke CC and AAA patients who had stopped smoking. Incidence rate will be calculated annually. |
| Incidence of AAA Growth Above 5 mm Within 6 Months | At 6-month intervals from baseline to V8 (month 36) | Incidence of AAA growth above 5 mm within 6 months will be measured in AAA patients who switch from smoking CC to using IQOS, as compared to AAA patients who continue smoking CC and AAA patients who had stopped smoking. Incidence rate will be calculated annually by counting the number of patients with an increase in maximum minor-axis AAA diameter of more than 5 mm within 6 months. |
| AAA Patients With an Overall Maximum Minor-axis AAA Diameter of >55mm in Male Patients and >50mm in Female Patients | From baseline to V8 (month 36) | The number of AAA patients with an overall maximum minor-axis AAA diameter \>55mm in male AAA patients and \>50mm in female AAA patients will be counted in AAA patients who switch from smoking CC to using IQOS, as compared to AAA patients who continue smoking CC and AAA patients who had stopped smoking. (Note that the 95% CI is calculated by exact method (Clopper-Pearson) and refers to CI for a proportion). |
| Systolic Blood Pressure | From V1 (screening) to V8 (month 36) | This cardiovascular BoPH (systolic blood pressure) will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking. |
| Urinary Nicotine Equivalents (NEQ) | From baseline to V8 (month 36) | To measure nicotine exposure over time in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC, and AAA patients who had stopped smoking. (NEQ adjusted for creatinine (mg/g creat)). |
| Percentage of Subjects Without Open Surgical AAA Treatment or AAA Endovascular Repair Over Time | From time of AAA diagnosis (prior to study participation) until V8 (month 36), a time frame of up to 7 years | This outcome measured the percentage of subjects without surgery or endovascular repair over time in AAA patients who switch from smoking CC to using IQOS, as compared to AAA patients who continue smoking CC and AAA patients who had stopped smoking. |
| Body Weight | From V1 (screening) to V8 (month 36) | This cardiovascular BoPH (body weight) will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking. |
| Waist Circumference | From V1 (screening) to V8 (month 36) | This cardiovascular BoPH (waist circumference) will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking. |
| Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) | From baseline to V8 (month 36) | This biomarker of exposure to a tobacco smoke constituent will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking. |
| Total N-nitrosonornicotine (Total NNN) | From baseline to V8 (month 36) | This biomarker of exposure to a tobacco smoke constituent will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking. |
| 2-cyanoethylmercapturic Acid (2-CyEMA) | From baseline to V8 (month 36) | This biomarker of exposure to a tobacco smoke constituent will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking. |
| Diastolic Blood Pressure | From V1 (screening) to V8 (month 36) | This cardiovascular BoPH (diastolic blood pressure) will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IQOS Arm Patients diagnosed with AAA, switching from cigarette smoking to IQOS use
IQOS: AAA patients will switch from cigarette smoking to ad libitum IQOS use, with no flavor variant restrictions. | 16 |
| CC Arm Patients diagnosed with AAA, continuing to smoke cigarettes
Cigarette: AAA patients will continue to smoke their cigarettes ad libitum, with no brand restrictions. | 16 |
| Smoking Cessation Arm Patients diagnosed with AAA, who have completely stopped smoking and are not using any other tobacco or nicotine-containing product(s)
Smoking Cessation: AAA patients who have completely quit smoking will continue to remain abstinent from smoking cigarettes or using any tobacco or nicotine-containing product(s) | 16 |
| Total | 48 |
Baseline characteristics
| Characteristic | IQOS Arm | CC Arm | Smoking Cessation Arm | Total |
|---|---|---|---|---|
| Age, Continuous | 71.0 years STANDARD_DEVIATION 6.19 | 70.4 years STANDARD_DEVIATION 7.73 | 71.3 years STANDARD_DEVIATION 2.59 | 70.9 years STANDARD_DEVIATION 5.79 |
| Nationality Japanese | 16 Participants | 16 Participants | 16 Participants | 48 Participants |
| Nationality Other | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 16 Participants | 16 Participants | 16 Participants | 48 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 16 Participants | 16 Participants | 16 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 16 | 1 / 16 | 0 / 16 |
| other Total, other adverse events | 14 / 16 | 13 / 16 | 14 / 16 |
| serious Total, serious adverse events | 3 / 16 | 5 / 16 | 7 / 16 |
Outcome results
Primary
AAA Annual Growth Rate Over Time
AAA annual growth rate will be measured in AAA patients who switch from smoking cigarettes to using IQOS, and AAA patients who continue to smoke CC, as compared to AAA patients who had stopped smoking. Maximum minor-axis AAA diameter in mm will be measured. Annual growth rate will be calculated by annualizing the slope of the linear regression over the available diameter measurements.
Time frame: At 6-month intervals from baseline to V8 (month 36)
Population: Full Analysis Set (FAS) population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| IQOS Arm | AAA Annual Growth Rate Over Time | 1.80 (mm/year) |
| CC Arm | AAA Annual Growth Rate Over Time | 1.87 (mm/year) |
| Smoking Cessation Arm | AAA Annual Growth Rate Over Time | 1.27 (mm/year) |
Secondary
2-cyanoethylmercapturic Acid (2-CyEMA)
This biomarker of exposure to a tobacco smoke constituent will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking.
Time frame: From baseline to V8 (month 36)
Population: Full Analysis Set (FAS) population. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| IQOS Arm | 2-cyanoethylmercapturic Acid (2-CyEMA) | V3 (Month 6) | 20.21 ng/mg creat |
| IQOS Arm | 2-cyanoethylmercapturic Acid (2-CyEMA) | V6 (Month 24) | 13.88 ng/mg creat |
| IQOS Arm | 2-cyanoethylmercapturic Acid (2-CyEMA) | V5 (Month 18) | 12.53 ng/mg creat |
| IQOS Arm | 2-cyanoethylmercapturic Acid (2-CyEMA) | V2 (Baseline) | 95.38 ng/mg creat |
| IQOS Arm | 2-cyanoethylmercapturic Acid (2-CyEMA) | V8 (Month 36) | 12.32 ng/mg creat |
| IQOS Arm | 2-cyanoethylmercapturic Acid (2-CyEMA) | V7 (Month 30) | 8.25 ng/mg creat |
| IQOS Arm | 2-cyanoethylmercapturic Acid (2-CyEMA) | V4 (Month 12) | 13.29 ng/mg creat |
| CC Arm | 2-cyanoethylmercapturic Acid (2-CyEMA) | V5 (Month 18) | 56.77 ng/mg creat |
| CC Arm | 2-cyanoethylmercapturic Acid (2-CyEMA) | V2 (Baseline) | 98.95 ng/mg creat |
| CC Arm | 2-cyanoethylmercapturic Acid (2-CyEMA) | V3 (Month 6) | 111.31 ng/mg creat |
| CC Arm | 2-cyanoethylmercapturic Acid (2-CyEMA) | V4 (Month 12) | 82.46 ng/mg creat |
| CC Arm | 2-cyanoethylmercapturic Acid (2-CyEMA) | V6 (Month 24) | 48.40 ng/mg creat |
| CC Arm | 2-cyanoethylmercapturic Acid (2-CyEMA) | V7 (Month 30) | 52.08 ng/mg creat |
| CC Arm | 2-cyanoethylmercapturic Acid (2-CyEMA) | V8 (Month 36) | 46.19 ng/mg creat |
| Smoking Cessation Arm | 2-cyanoethylmercapturic Acid (2-CyEMA) | V6 (Month 24) | 1.77 ng/mg creat |
| Smoking Cessation Arm | 2-cyanoethylmercapturic Acid (2-CyEMA) | V3 (Month 6) | 1.67 ng/mg creat |
| Smoking Cessation Arm | 2-cyanoethylmercapturic Acid (2-CyEMA) | V8 (Month 36) | 1.86 ng/mg creat |
| Smoking Cessation Arm | 2-cyanoethylmercapturic Acid (2-CyEMA) | V7 (Month 30) | 1.51 ng/mg creat |
| Smoking Cessation Arm | 2-cyanoethylmercapturic Acid (2-CyEMA) | V5 (Month 18) | 1.70 ng/mg creat |
| Smoking Cessation Arm | 2-cyanoethylmercapturic Acid (2-CyEMA) | V4 (Month 12) | 2.30 ng/mg creat |
| Smoking Cessation Arm | 2-cyanoethylmercapturic Acid (2-CyEMA) | V2 (Baseline) | 2.36 ng/mg creat |
Secondary
AAA Patients With an Overall Maximum Minor-axis AAA Diameter of >55mm in Male Patients and >50mm in Female Patients
The number of AAA patients with an overall maximum minor-axis AAA diameter \>55mm in male AAA patients and \>50mm in female AAA patients will be counted in AAA patients who switch from smoking CC to using IQOS, as compared to AAA patients who continue smoking CC and AAA patients who had stopped smoking. (Note that the 95% CI is calculated by exact method (Clopper-Pearson) and refers to CI for a proportion).
Time frame: From baseline to V8 (month 36)
Population: Full Analysis Set (FAS) population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IQOS Arm | AAA Patients With an Overall Maximum Minor-axis AAA Diameter of >55mm in Male Patients and >50mm in Female Patients | 0 participants |
| CC Arm | AAA Patients With an Overall Maximum Minor-axis AAA Diameter of >55mm in Male Patients and >50mm in Female Patients | 0 participants |
| Smoking Cessation Arm | AAA Patients With an Overall Maximum Minor-axis AAA Diameter of >55mm in Male Patients and >50mm in Female Patients | 0 participants |
Secondary
Body Weight
This cardiovascular BoPH (body weight) will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking.
Time frame: From V1 (screening) to V8 (month 36)
Population: Full Analysis Set (FAS) population
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| IQOS Arm | Body Weight | V8 (Month 36) | 68.74 kg |
| IQOS Arm | Body Weight | V1 (Screening) | 68.44 kg |
| IQOS Arm | Body Weight | V2 (Baseline) | 68.13 kg |
| IQOS Arm | Body Weight | V3 (Month 6) | 67.79 kg |
| IQOS Arm | Body Weight | V4 (Month 12) | 68.47 kg |
| IQOS Arm | Body Weight | V5 (Month 18) | 69.41 kg |
| IQOS Arm | Body Weight | V6 (Month 24) | 68.51 kg |
| IQOS Arm | Body Weight | V7 (Month 30) | 67.61 kg |
| CC Arm | Body Weight | V2 (Baseline) | 66.61 kg |
| CC Arm | Body Weight | V6 (Month 24) | 67.82 kg |
| CC Arm | Body Weight | V3 (Month 6) | 65.88 kg |
| CC Arm | Body Weight | V4 (Month 12) | 66.51 kg |
| CC Arm | Body Weight | V5 (Month 18) | 67.60 kg |
| CC Arm | Body Weight | V8 (Month 36) | 69.71 kg |
| CC Arm | Body Weight | V1 (Screening) | 66.63 kg |
| CC Arm | Body Weight | V7 (Month 30) | 69.08 kg |
| Smoking Cessation Arm | Body Weight | V2 (Baseline) | 67.93 kg |
| Smoking Cessation Arm | Body Weight | V1 (Screening) | 67.91 kg |
| Smoking Cessation Arm | Body Weight | V8 (Month 36) | 66.34 kg |
| Smoking Cessation Arm | Body Weight | V3 (Month 6) | 67.98 kg |
| Smoking Cessation Arm | Body Weight | V6 (Month 24) | 67.14 kg |
| Smoking Cessation Arm | Body Weight | V5 (Month 18) | 66.70 kg |
| Smoking Cessation Arm | Body Weight | V4 (Month 12) | 67.27 kg |
| Smoking Cessation Arm | Body Weight | V7 (Month 30) | 66.03 kg |
Secondary
Diastolic Blood Pressure
This cardiovascular BoPH (diastolic blood pressure) will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking.
Time frame: From V1 (screening) to V8 (month 36)
Population: Full Analysis Set (FAS) population.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| IQOS Arm | Diastolic Blood Pressure | V1 (Screening) | 75.4 mmHg |
| IQOS Arm | Diastolic Blood Pressure | V6 (Month 24) | 79.0 mmHg |
| IQOS Arm | Diastolic Blood Pressure | V3 (Month 6) | 79.7 mmHg |
| IQOS Arm | Diastolic Blood Pressure | V2 (Baseline) | 76.6 mmHg |
| IQOS Arm | Diastolic Blood Pressure | V8 (Month 36) | 73.8 mmHg |
| IQOS Arm | Diastolic Blood Pressure | V7 (Month 30) | 76.3 mmHg |
| IQOS Arm | Diastolic Blood Pressure | V5 (Month 18) | 74.8 mmHg |
| IQOS Arm | Diastolic Blood Pressure | V4 (Month 12) | 76.3 mmHg |
| CC Arm | Diastolic Blood Pressure | V2 (Baseline) | 76.6 mmHg |
| CC Arm | Diastolic Blood Pressure | V7 (Month 30) | 79.8 mmHg |
| CC Arm | Diastolic Blood Pressure | V8 (Month 36) | 77.8 mmHg |
| CC Arm | Diastolic Blood Pressure | V1 (Screening) | 76.6 mmHg |
| CC Arm | Diastolic Blood Pressure | V3 (Month 6) | 77.3 mmHg |
| CC Arm | Diastolic Blood Pressure | V4 (Month 12) | 77.3 mmHg |
| CC Arm | Diastolic Blood Pressure | V5 (Month 18) | 78.3 mmHg |
| CC Arm | Diastolic Blood Pressure | V6 (Month 24) | 78.5 mmHg |
| Smoking Cessation Arm | Diastolic Blood Pressure | V7 (Month 30) | 69.2 mmHg |
| Smoking Cessation Arm | Diastolic Blood Pressure | V4 (Month 12) | 74.1 mmHg |
| Smoking Cessation Arm | Diastolic Blood Pressure | V8 (Month 36) | 67.0 mmHg |
| Smoking Cessation Arm | Diastolic Blood Pressure | V6 (Month 24) | 72.7 mmHg |
| Smoking Cessation Arm | Diastolic Blood Pressure | V1 (Screening) | 72.9 mmHg |
| Smoking Cessation Arm | Diastolic Blood Pressure | V5 (Month 18) | 71.5 mmHg |
| Smoking Cessation Arm | Diastolic Blood Pressure | V3 (Month 6) | 73.9 mmHg |
| Smoking Cessation Arm | Diastolic Blood Pressure | V2 (Baseline) | 77.3 mmHg |
Secondary
Incidence of AAA Growth Above 5 mm Within 6 Months
Incidence of AAA growth above 5 mm within 6 months will be measured in AAA patients who switch from smoking CC to using IQOS, as compared to AAA patients who continue smoking CC and AAA patients who had stopped smoking. Incidence rate will be calculated annually by counting the number of patients with an increase in maximum minor-axis AAA diameter of more than 5 mm within 6 months.
Time frame: At 6-month intervals from baseline to V8 (month 36)
Population: Full Analysis Set (FAS) population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IQOS Arm | Incidence of AAA Growth Above 5 mm Within 6 Months | 0 events per person-year |
| CC Arm | Incidence of AAA Growth Above 5 mm Within 6 Months | 0 events per person-year |
| Smoking Cessation Arm | Incidence of AAA Growth Above 5 mm Within 6 Months | 0 events per person-year |
Secondary
Incidence of Open Surgical AAA Treatment or AAA Endovascular Repair and AAA Rupture
The incidence of open surgical AAA treatment or AAA endovascular repair and AAA rupture will be measured in AAA patients who switch from smoking CC to using IQOS, as compared to AAA patients who continue to smoke CC and AAA patients who had stopped smoking. Incidence rate will be calculated annually.
Time frame: From baseline to V8 (month 36)
Population: Full Analysis Set (FAS) population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IQOS Arm | Incidence of Open Surgical AAA Treatment or AAA Endovascular Repair and AAA Rupture | Number of patients with open surgical AAA treatment or endovascular repair annually | 0.05 events per person-year |
| IQOS Arm | Incidence of Open Surgical AAA Treatment or AAA Endovascular Repair and AAA Rupture | Number of patients with AAA rupture annually | 0.00 events per person-year |
| CC Arm | Incidence of Open Surgical AAA Treatment or AAA Endovascular Repair and AAA Rupture | Number of patients with open surgical AAA treatment or endovascular repair annually | 0.05 events per person-year |
| CC Arm | Incidence of Open Surgical AAA Treatment or AAA Endovascular Repair and AAA Rupture | Number of patients with AAA rupture annually | 0.00 events per person-year |
| Smoking Cessation Arm | Incidence of Open Surgical AAA Treatment or AAA Endovascular Repair and AAA Rupture | Number of patients with open surgical AAA treatment or endovascular repair annually | 0.05 events per person-year |
| Smoking Cessation Arm | Incidence of Open Surgical AAA Treatment or AAA Endovascular Repair and AAA Rupture | Number of patients with AAA rupture annually | 0.00 events per person-year |
Secondary
Percentage of Subjects Without Open Surgical AAA Treatment or AAA Endovascular Repair Over Time
This outcome measured the percentage of subjects without surgery or endovascular repair over time in AAA patients who switch from smoking CC to using IQOS, as compared to AAA patients who continue smoking CC and AAA patients who had stopped smoking.
Time frame: From time of AAA diagnosis (prior to study participation) until V8 (month 36), a time frame of up to 7 years
Population: Full Analysis Set (FAS) population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IQOS Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Endovascular Repair Over Time | V8 (Month 36) | 83.9 percentage |
| IQOS Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Endovascular Repair Over Time | V4 (Month 12) | 83.9 percentage |
| IQOS Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Endovascular Repair Over Time | Baseline -12 months | 100.0 percentage |
| IQOS Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Endovascular Repair Over Time | Baseline -24 months | 100.0 percentage |
| IQOS Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Endovascular Repair Over Time | V6 (Month 24) | 83.9 percentage |
| IQOS Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Endovascular Repair Over Time | V2 (Baseline) | 100.0 percentage |
| IQOS Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Endovascular Repair Over Time | Baseline -36 months | 100.0 percentage |
| CC Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Endovascular Repair Over Time | V2 (Baseline) | 100.0 percentage |
| CC Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Endovascular Repair Over Time | V6 (Month 24) | 80.0 percentage |
| CC Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Endovascular Repair Over Time | Baseline -36 months | 100.0 percentage |
| CC Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Endovascular Repair Over Time | V8 (Month 36) | 80.0 percentage |
| CC Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Endovascular Repair Over Time | Baseline -24 months | 100.0 percentage |
| CC Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Endovascular Repair Over Time | V4 (Month 12) | 80.0 percentage |
| CC Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Endovascular Repair Over Time | Baseline -12 months | 100.0 percentage |
| Smoking Cessation Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Endovascular Repair Over Time | V8 (Month 36) | 87.5 percentage |
| Smoking Cessation Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Endovascular Repair Over Time | V4 (Month 12) | 87.5 percentage |
| Smoking Cessation Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Endovascular Repair Over Time | Baseline -24 months | 87.5 percentage |
| Smoking Cessation Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Endovascular Repair Over Time | Baseline -12 months | 87.5 percentage |
| Smoking Cessation Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Endovascular Repair Over Time | V2 (Baseline) | 87.5 percentage |
| Smoking Cessation Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Endovascular Repair Over Time | V6 (Month 24) | 87.5 percentage |
| Smoking Cessation Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Endovascular Repair Over Time | Baseline -36 months | 100.0 percentage |
Secondary
Percentage of Subjects Without Open Surgical AAA Treatment or AAA Rupture Over Time
This outcome measured the percentage of subjects without surgery or AAA rupture over time in AAA patients who switch from smoking CC to using IQOS, as compared to AAA patients who continue smoking CC and AAA patients who had stopped smoking.
Time frame: From time of AAA diagnosis (prior to study participation) until V8 (month 36), a time frame of up to 7 years
Population: Full Analysis Set (FAS) population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IQOS Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Rupture Over Time | Baseline -24 months | 100.0 percentage |
| IQOS Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Rupture Over Time | V4 (Month 12) | 100.0 percentage |
| IQOS Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Rupture Over Time | V2 (Baseline) | 100.0 percentage |
| IQOS Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Rupture Over Time | Baseline -36 months | 100.0 percentage |
| IQOS Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Rupture Over Time | V8 (Month 36) | 100.0 percentage |
| IQOS Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Rupture Over Time | V6 (Month 24) | 100.0 percentage |
| IQOS Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Rupture Over Time | Baseline -12 months | 100.0 percentage |
| CC Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Rupture Over Time | V2 (Baseline) | 100.0 percentage |
| CC Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Rupture Over Time | Baseline -36 months | 100.0 percentage |
| CC Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Rupture Over Time | Baseline -24 months | 100.0 percentage |
| CC Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Rupture Over Time | Baseline -12 months | 100.0 percentage |
| CC Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Rupture Over Time | V4 (Month 12) | 100.0 percentage |
| CC Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Rupture Over Time | V6 (Month 24) | 100.0 percentage |
| CC Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Rupture Over Time | V8 (Month 36) | 100.0 percentage |
| Smoking Cessation Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Rupture Over Time | V4 (Month 12) | 100.0 percentage |
| Smoking Cessation Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Rupture Over Time | Baseline -24 months | 100.0 percentage |
| Smoking Cessation Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Rupture Over Time | V8 (Month 36) | 100.0 percentage |
| Smoking Cessation Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Rupture Over Time | V6 (Month 24) | 100.0 percentage |
| Smoking Cessation Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Rupture Over Time | V2 (Baseline) | 100.0 percentage |
| Smoking Cessation Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Rupture Over Time | Baseline -12 months | 100.0 percentage |
| Smoking Cessation Arm | Percentage of Subjects Without Open Surgical AAA Treatment or AAA Rupture Over Time | Baseline -36 months | 100.0 percentage |
Secondary
Systolic Blood Pressure
This cardiovascular BoPH (systolic blood pressure) will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking.
Time frame: From V1 (screening) to V8 (month 36)
Population: Full Analysis Set (FAS) population
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| IQOS Arm | Systolic Blood Pressure | V1 (Screening) | 134.8 mmHg |
| IQOS Arm | Systolic Blood Pressure | V2 (Baseline) | 132.5 mmHg |
| IQOS Arm | Systolic Blood Pressure | V3 (Month 6) | 138.8 mmHg |
| IQOS Arm | Systolic Blood Pressure | V4 (Month 12) | 132.7 mmHg |
| IQOS Arm | Systolic Blood Pressure | V5 (Month 18) | 133.9 mmHg |
| IQOS Arm | Systolic Blood Pressure | V6 (Month 24) | 136.6 mmHg |
| IQOS Arm | Systolic Blood Pressure | V7 (Month 30) | 128.8 mmHg |
| IQOS Arm | Systolic Blood Pressure | V8 (Month 36) | 131.7 mmHg |
| CC Arm | Systolic Blood Pressure | V3 (Month 6) | 131.1 mmHg |
| CC Arm | Systolic Blood Pressure | V7 (Month 30) | 136.1 mmHg |
| CC Arm | Systolic Blood Pressure | V4 (Month 12) | 135.0 mmHg |
| CC Arm | Systolic Blood Pressure | V5 (Month 18) | 130.6 mmHg |
| CC Arm | Systolic Blood Pressure | V6 (Month 24) | 129.7 mmHg |
| CC Arm | Systolic Blood Pressure | V1 (Screening) | 128.0 mmHg |
| CC Arm | Systolic Blood Pressure | V2 (Baseline) | 128.9 mmHg |
| CC Arm | Systolic Blood Pressure | V8 (Month 36) | 131.6 mmHg |
| Smoking Cessation Arm | Systolic Blood Pressure | V3 (Month 6) | 130.3 mmHg |
| Smoking Cessation Arm | Systolic Blood Pressure | V2 (Baseline) | 135.9 mmHg |
| Smoking Cessation Arm | Systolic Blood Pressure | V1 (Screening) | 124.0 mmHg |
| Smoking Cessation Arm | Systolic Blood Pressure | V4 (Month 12) | 129.3 mmHg |
| Smoking Cessation Arm | Systolic Blood Pressure | V7 (Month 30) | 126.0 mmHg |
| Smoking Cessation Arm | Systolic Blood Pressure | V6 (Month 24) | 128.1 mmHg |
| Smoking Cessation Arm | Systolic Blood Pressure | V5 (Month 18) | 126.9 mmHg |
| Smoking Cessation Arm | Systolic Blood Pressure | V8 (Month 36) | 125.3 mmHg |
Secondary
Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL)
This biomarker of exposure to a tobacco smoke constituent will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking.
Time frame: From baseline to V8 (month 36)
Population: Full Analysis Set (FAS) population. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| IQOS Arm | Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) | V6 (Month 24) | 33.02 pg/mg creat |
| IQOS Arm | Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) | V7 (Month 30) | 27.54 pg/mg creat |
| IQOS Arm | Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) | V8 (Month 36) | 35.24 pg/mg creat |
| IQOS Arm | Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) | V3 (Month 6) | 39.83 pg/mg creat |
| IQOS Arm | Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) | V4 (Month 12) | 27.12 pg/mg creat |
| IQOS Arm | Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) | V2 (Baseline) | 124.09 pg/mg creat |
| IQOS Arm | Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) | V5 (Month 18) | 32.81 pg/mg creat |
| CC Arm | Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) | V4 (Month 12) | 81.24 pg/mg creat |
| CC Arm | Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) | V3 (Month 6) | 108.70 pg/mg creat |
| CC Arm | Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) | V7 (Month 30) | 61.78 pg/mg creat |
| CC Arm | Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) | V2 (Baseline) | 87.34 pg/mg creat |
| CC Arm | Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) | V6 (Month 24) | 57.78 pg/mg creat |
| CC Arm | Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) | V8 (Month 36) | 42.36 pg/mg creat |
| CC Arm | Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) | V5 (Month 18) | 61.85 pg/mg creat |
| Smoking Cessation Arm | Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) | V8 (Month 36) | 0 pg/mg creat |
| Smoking Cessation Arm | Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) | V5 (Month 18) | 0 pg/mg creat |
| Smoking Cessation Arm | Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) | V6 (Month 24) | 0 pg/mg creat |
| Smoking Cessation Arm | Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) | V2 (Baseline) | 0 pg/mg creat |
| Smoking Cessation Arm | Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) | V4 (Month 12) | 0 pg/mg creat |
| Smoking Cessation Arm | Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) | V7 (Month 30) | 0 pg/mg creat |
| Smoking Cessation Arm | Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) | V3 (Month 6) | 0 pg/mg creat |
Secondary
Total N-nitrosonornicotine (Total NNN)
This biomarker of exposure to a tobacco smoke constituent will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking.
Time frame: From baseline to V8 (month 36)
Population: Full Analysis Set (FAS) population. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| IQOS Arm | Total N-nitrosonornicotine (Total NNN) | V4 (Month 12) | 0.98 pg/mg creatinine |
| IQOS Arm | Total N-nitrosonornicotine (Total NNN) | V6 (Month 24) | 1.34 pg/mg creatinine |
| IQOS Arm | Total N-nitrosonornicotine (Total NNN) | V5 (Month 18) | 1.28 pg/mg creatinine |
| IQOS Arm | Total N-nitrosonornicotine (Total NNN) | V3 (Month 6) | 1.39 pg/mg creatinine |
| IQOS Arm | Total N-nitrosonornicotine (Total NNN) | V8 (Month 36) | 1.10 pg/mg creatinine |
| IQOS Arm | Total N-nitrosonornicotine (Total NNN) | V7 (Month 30) | 1.20 pg/mg creatinine |
| IQOS Arm | Total N-nitrosonornicotine (Total NNN) | V2 (Baseline) | 3.26 pg/mg creatinine |
| CC Arm | Total N-nitrosonornicotine (Total NNN) | V5 (Month 18) | 1.47 pg/mg creatinine |
| CC Arm | Total N-nitrosonornicotine (Total NNN) | V3 (Month 6) | 2.86 pg/mg creatinine |
| CC Arm | Total N-nitrosonornicotine (Total NNN) | V4 (Month 12) | 2.12 pg/mg creatinine |
| CC Arm | Total N-nitrosonornicotine (Total NNN) | V2 (Baseline) | 2.09 pg/mg creatinine |
| CC Arm | Total N-nitrosonornicotine (Total NNN) | V6 (Month 24) | 1.55 pg/mg creatinine |
| CC Arm | Total N-nitrosonornicotine (Total NNN) | V7 (Month 30) | 1.31 pg/mg creatinine |
| CC Arm | Total N-nitrosonornicotine (Total NNN) | V8 (Month 36) | 1.27 pg/mg creatinine |
| Smoking Cessation Arm | Total N-nitrosonornicotine (Total NNN) | V6 (Month 24) | 0 pg/mg creatinine |
| Smoking Cessation Arm | Total N-nitrosonornicotine (Total NNN) | V4 (Month 12) | 0 pg/mg creatinine |
| Smoking Cessation Arm | Total N-nitrosonornicotine (Total NNN) | V8 (Month 36) | 0 pg/mg creatinine |
| Smoking Cessation Arm | Total N-nitrosonornicotine (Total NNN) | V7 (Month 30) | 0 pg/mg creatinine |
| Smoking Cessation Arm | Total N-nitrosonornicotine (Total NNN) | V5 (Month 18) | 0 pg/mg creatinine |
| Smoking Cessation Arm | Total N-nitrosonornicotine (Total NNN) | V2 (Baseline) | 0 pg/mg creatinine |
| Smoking Cessation Arm | Total N-nitrosonornicotine (Total NNN) | V3 (Month 6) | 0 pg/mg creatinine |
Secondary
Urinary Nicotine Equivalents (NEQ)
To measure nicotine exposure over time in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC, and AAA patients who had stopped smoking. (NEQ adjusted for creatinine (mg/g creat)).
Time frame: From baseline to V8 (month 36)
Population: Full Analysis Set (FAS) population. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| IQOS Arm | Urinary Nicotine Equivalents (NEQ) | V3 (Month 6) | 5.13 mg/g creat |
| IQOS Arm | Urinary Nicotine Equivalents (NEQ) | V6 (Month 24) | 4.65 mg/g creat |
| IQOS Arm | Urinary Nicotine Equivalents (NEQ) | V5 (Month 18) | 5.86 mg/g creat |
| IQOS Arm | Urinary Nicotine Equivalents (NEQ) | V2 (Baseline) | 5.70 mg/g creat |
| IQOS Arm | Urinary Nicotine Equivalents (NEQ) | V8 (Month 36) | 0 mg/g creat |
| IQOS Arm | Urinary Nicotine Equivalents (NEQ) | V7 (Month 30) | 3.88 mg/g creat |
| IQOS Arm | Urinary Nicotine Equivalents (NEQ) | V4 (Month 12) | 4.30 mg/g creat |
| CC Arm | Urinary Nicotine Equivalents (NEQ) | V5 (Month 18) | 0.0 mg/g creat |
| CC Arm | Urinary Nicotine Equivalents (NEQ) | V2 (Baseline) | 6.30 mg/g creat |
| CC Arm | Urinary Nicotine Equivalents (NEQ) | V3 (Month 6) | 7.46 mg/g creat |
| CC Arm | Urinary Nicotine Equivalents (NEQ) | V4 (Month 12) | 5.50 mg/g creat |
| CC Arm | Urinary Nicotine Equivalents (NEQ) | V6 (Month 24) | 4.32 mg/g creat |
| CC Arm | Urinary Nicotine Equivalents (NEQ) | V7 (Month 30) | 4.24 mg/g creat |
| CC Arm | Urinary Nicotine Equivalents (NEQ) | V8 (Month 36) | 4.20 mg/g creat |
| Smoking Cessation Arm | Urinary Nicotine Equivalents (NEQ) | V6 (Month 24) | 0 mg/g creat |
| Smoking Cessation Arm | Urinary Nicotine Equivalents (NEQ) | V3 (Month 6) | 0 mg/g creat |
| Smoking Cessation Arm | Urinary Nicotine Equivalents (NEQ) | V8 (Month 36) | 0 mg/g creat |
| Smoking Cessation Arm | Urinary Nicotine Equivalents (NEQ) | V7 (Month 30) | 0 mg/g creat |
| Smoking Cessation Arm | Urinary Nicotine Equivalents (NEQ) | V5 (Month 18) | 0 mg/g creat |
| Smoking Cessation Arm | Urinary Nicotine Equivalents (NEQ) | V4 (Month 12) | 0 mg/g creat |
| Smoking Cessation Arm | Urinary Nicotine Equivalents (NEQ) | V2 (Baseline) | 0 mg/g creat |
Secondary
Waist Circumference
This cardiovascular BoPH (waist circumference) will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking.
Time frame: From V1 (screening) to V8 (month 36)
Population: Full Analysis Set (FAS) population
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| IQOS Arm | Waist Circumference | V1 (Screening) | 90.51 cm |
| IQOS Arm | Waist Circumference | V2 (Baseline) | 89.88 cm |
| IQOS Arm | Waist Circumference | V3 (Month 6) | 89.95 cm |
| IQOS Arm | Waist Circumference | V4 (Month 12) | 89.75 cm |
| IQOS Arm | Waist Circumference | V5 (Month 18) | 91.73 cm |
| IQOS Arm | Waist Circumference | V6 (Month 24) | 89.14 cm |
| IQOS Arm | Waist Circumference | V7 (Month 30) | 89.04 cm |
| IQOS Arm | Waist Circumference | V8 (Month 36) | 91.78 cm |
| CC Arm | Waist Circumference | V3 (Month 6) | 89.91 cm |
| CC Arm | Waist Circumference | V7 (Month 30) | 93.33 cm |
| CC Arm | Waist Circumference | V4 (Month 12) | 89.46 cm |
| CC Arm | Waist Circumference | V5 (Month 18) | 90.71 cm |
| CC Arm | Waist Circumference | V6 (Month 24) | 91.55 cm |
| CC Arm | Waist Circumference | V1 (Screening) | 90.30 cm |
| CC Arm | Waist Circumference | V2 (Baseline) | 91.01 cm |
| CC Arm | Waist Circumference | V8 (Month 36) | 92.30 cm |
| Smoking Cessation Arm | Waist Circumference | V3 (Month 6) | 91.16 cm |
| Smoking Cessation Arm | Waist Circumference | V2 (Baseline) | 93.33 cm |
| Smoking Cessation Arm | Waist Circumference | V1 (Screening) | 91.40 cm |
| Smoking Cessation Arm | Waist Circumference | V4 (Month 12) | 91.78 cm |
| Smoking Cessation Arm | Waist Circumference | V7 (Month 30) | 91.43 cm |
| Smoking Cessation Arm | Waist Circumference | V6 (Month 24) | 91.54 cm |
| Smoking Cessation Arm | Waist Circumference | V5 (Month 18) | 91.82 cm |
| Smoking Cessation Arm | Waist Circumference | V8 (Month 36) | 91.36 cm |