Comparison of Abdominal Aortic Aneurysm Growth in Adult S... | NCT03837704

NCT03837704

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IQOS Arm	Active Comparator	Patients diagnosed with AAA, switching from cigarette smoking to IQOS use	Other: IQOS
CC Arm	Active Comparator	Patients diagnosed with AAA, continuing to smoke cigarettes	Other: Cigarette
Smoking Cessation Arm	Active Comparator	Patients diagnosed with AAA, who have completely stopped smoking and are not using any other tobacco or nicotine-containing product(s)	Other: Smoking Cessation

Name	Type	Description	Arm Group Labels	Other Names
IQOS	Other	AAA patients will switch from cigarette smoking to ad libitum IQOS use, with no flavor variant restrictions.	IQOS Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	At 6-month intervals from baseline to V8 (month 36)

Secondary Outcomes

Measure	Description	Time Frame
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.	From time of AAA diagnosis (prior to study participation) until V8 (month 36), a time frame of up to 7 years

Eligibility Module

Eligibility 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.

Contacts/Locations Module

Name	Affiliation	Role
Xavier Jaumont, MD	Philip Morris Products SA	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Chiba-Nishi General Hospital		Matsudo	Chiba	270-2251	Japan
Tokyo Bay Urayasu Ichikawa Medical Center

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.
FG001	CC Arm

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 17, 2021	Oct 16, 2024

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Patients diagnosed with AAA, continuing to smoke cigarettes

Cigarette: AAA patients will continue to smoke their cigarettes ad libitum, with no brand restrictions.

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	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)
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00071.0± 6.19 BG00170.4± 7.73 BG00271.3± 2.59 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0000 BG0010 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Nationality

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Japanese	BG00016 BG00116 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

Full Analysis Set (FAS) population

Posted

Mean

95% Confidence Interval

(mm/year)

At 6-month intervals from baseline to V8 (month 36)

ID	Title	Description
OG000	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.
OG001	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.
OG002	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)

Units	Counts
Participants	OG00015 OG00116 OG00215

Title

Denominators

Categories

Title	Measurements
	OG0001.80(0.94 to 2.66) OG0011.87(1.33 to 2.40) OG0021.27(0.84 to 1.70)

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.

Full Analysis Set (FAS) population

Posted

Number

95% Confidence Interval

percentage

From time of AAA diagnosis (prior to study participation) until V8 (month 36), a time frame of up to 7 years

ID	Title	Description
OG000	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.
OG001	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.
OG002	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)

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.

Full Analysis Set (FAS) population

Posted

Number

95% Confidence Interval

percentage

From time of AAA diagnosis (prior to study participation) until V8 (month 36), a time frame of up to 7 years

ID	Title	Description
OG000	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.
OG001	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.
OG002	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)

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.

Full Analysis Set (FAS) population

Posted

Number

events per person-year

From baseline to V8 (month 36)

ID	Title	Description
OG000	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.
OG001	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.
OG002	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)

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.

Full Analysis Set (FAS) population

Posted

Number

95% Confidence Interval

events per person-year

At 6-month intervals from baseline to V8 (month 36)

ID	Title	Description
OG000	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.
OG001	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.
OG002	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)

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).

Full Analysis Set (FAS) population

Posted

Number

95% Confidence Interval

participants

From baseline to V8 (month 36)

ID	Title	Description
OG000	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.
OG001	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.
OG002	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)

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.

Full Analysis Set (FAS) population

Posted

Mean

95% Confidence Interval

mmHg

From V1 (screening) to V8 (month 36)

ID	Title	Description
OG000	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.
OG001	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.
OG002	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)

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)).

Full Analysis Set (FAS) population. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Geometric Mean

95% Confidence Interval

mg/g creat

From baseline to V8 (month 36)

ID	Title	Description
OG000	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.
OG001	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.
OG002	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)

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.

Full Analysis Set (FAS) population.

Posted

Mean

95% Confidence Interval

mmHg

From V1 (screening) to V8 (month 36)

ID	Title	Description
OG000	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.
OG001	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.
OG002	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)

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.

Full Analysis Set (FAS) population

Posted

Mean

95% Confidence Interval

From V1 (screening) to V8 (month 36)

ID	Title	Description
OG000	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.
OG001	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.
OG002	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)

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.

Full Analysis Set (FAS) population

Posted

Mean

95% Confidence Interval

From V1 (screening) to V8 (month 36)

ID	Title	Description
OG000	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.
OG001	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.
OG002	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)

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.

Full Analysis Set (FAS) population. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Geometric Mean

95% Confidence Interval

pg/mg creat

From baseline to V8 (month 36)

ID	Title	Description
OG000	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.
OG001	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.
OG002	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)

Secondary

Total N-nitrosonornicotine (Total NNN)

Full Analysis Set (FAS) population. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Geometric Mean

95% Confidence Interval

pg/mg creatinine

From baseline to V8 (month 36)

ID	Title	Description
OG000	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.
OG001	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.
OG002	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)

Secondary

2-cyanoethylmercapturic Acid (2-CyEMA)

Full Analysis Set (FAS) population. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Geometric Mean

95% Confidence Interval

ng/mg creat

From baseline to V8 (month 36)

ID	Title	Description
OG000	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.
OG001	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.
OG002	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)

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	1	16	3	16	14	16
EG001	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.	1	16	5	16	13	16
EG002	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)	0	16	7	16	14	16

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Atrial fibrillation	Cardiac disorders	Systematic Assessment	EG0002 events2 affected16 at risk EG0010 events0 affected16 at risk EG0020 events0 affected16 at risk
Death	General disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected16 at risk EG0020 events0 affected16 at risk
Angina unstable	Cardiac disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0020 events0 affected16 at risk
Acute myocardial infarction	Cardiac disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0021 events1 affected16 at risk
Angina pectoris	Cardiac disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0021 events1 affected16 at risk
Cardiac failure	Cardiac disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0021 events1 affected16 at risk
Myocardial ischaemia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0021 events1 affected16 at risk
Cataract	Eye disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0020 events0 affected16 at risk
Ileus	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0021 events1 affected16 at risk
Inguinal hernia	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0021 events1 affected16 at risk
Large intestine polyp	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0023 events3 affected16 at risk
Appendicitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0022 events1 affected16 at risk
Gastroenteritis	Infections and infestations	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0021 events1 affected16 at risk
Pneumonia	Infections and infestations	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0021 events1 affected16 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected16 at risk EG0020 events0 affected16 at risk
Patella fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected16 at risk EG0020 events0 affected16 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected16 at risk EG0020 events0 affected16 at risk
Inflammatory pseudotumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0020 events0 affected16 at risk
Cerebral haemorrhage	Nervous system disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0020 events0 affected16 at risk
Tarsal tunnel syndrome	Nervous system disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0020 events0 affected16 at risk
Peripheral arterial occlusive disease	Vascular disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0021 events1 affected16 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Dry eye	Eye disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0020 events0 affected16 at risk
Pterygium	Eye disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected16 at risk EG0020 events0 affected16 at risk
Vision blurred	Eye disorders	Systematic Assessment	EG0002 events2 affected16 at risk EG0010 events0 affected16 at risk EG0020 events0 affected16 at risk
Abdominal distension	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0021 events1 affected16 at risk
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0021 events1 affected16 at risk
Abdominal pain lower	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0021 events1 affected16 at risk
Abdominal pain upper	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected16 at risk EG0020 events0 affected16 at risk
Anal inflammation	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0021 events1 affected16 at risk
Chronic gastritis	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0021 events1 affected16 at risk
Colitis ulcerative	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0021 events1 affected16 at risk
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected16 at risk EG0010 events0 affected16 at risk EG0021 events1 affected16 at risk
Dental caries	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0021 events1 affected16 at risk
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0021 events1 affected16 at risk
Gastritis	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0022 events2 affected16 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0020 events0 affected16 at risk
Haematochezia	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0021 events1 affected16 at risk
Haemorrhoids	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0022 events2 affected16 at risk
Inguinal hernia	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected16 at risk EG0020 events0 affected16 at risk
Large intestine polyp	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0022 events2 affected16 at risk
Oropharyngeal pain	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0022 events2 affected16 at risk
Stomatitis	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected16 at risk EG0026 events2 affected16 at risk
Subileus	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0021 events1 affected16 at risk
Tooth loss	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0020 events0 affected16 at risk
Toothache	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0021 events1 affected16 at risk
Hepatic function abnormal	Hepatobiliary disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0020 events0 affected16 at risk
Liver disorder	Hepatobiliary disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0020 events0 affected16 at risk
Allergy to arthropod sting	Immune system disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected16 at risk EG0020 events0 affected16 at risk
Conjunctivitis allergic	Immune system disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0021 events1 affected16 at risk
Contrast media allergy	Immune system disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected16 at risk EG0020 events0 affected16 at risk
Morphoea	Immune system disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0020 events0 affected16 at risk
Rhinitis allergic	Immune system disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected16 at risk EG0021 events1 affected16 at risk
Urticaria	Immune system disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected16 at risk EG0020 events0 affected16 at risk
Bronchitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected16 at risk EG0020 events0 affected16 at risk
Cellulitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0020 events0 affected16 at risk
Conjunctivitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected16 at risk EG0020 events0 affected16 at risk
Corona virus infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0022 events2 affected16 at risk
Cystitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0021 events1 affected16 at risk
Dermatophytosis of nail	Infections and infestations	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0020 events0 affected16 at risk
Gastroenteritis	Infections and infestations	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected16 at risk EG0020 events0 affected16 at risk
Gingivitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0021 events1 affected16 at risk
Herpes ophthalmic	Infections and infestations	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0021 events1 affected16 at risk
Herpes zoster	Infections and infestations	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected16 at risk EG0023 events3 affected16 at risk
Influenza	Infections and infestations	Systematic Assessment	EG0002 events2 affected16 at risk EG0010 events0 affected16 at risk EG0020 events0 affected16 at risk
Ophthalmic herpes zoster	Infections and infestations	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected16 at risk EG0020 events0 affected16 at risk
Oral herpes	Infections and infestations	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0020 events0 affected16 at risk
Periodontitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events1 affected16 at risk EG0020 events0 affected16 at risk
Pharyngitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0020 events0 affected16 at risk
Pneumonia	Infections and infestations	Systematic Assessment	EG0002 events2 affected16 at risk EG0010 events0 affected16 at risk EG0020 events0 affected16 at risk
Tinea infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0021 events1 affected16 at risk
Viral upper respiratory tract infection	Infections and infestations	Systematic Assessment	EG0002 events2 affected16 at risk EG0013 events2 affected16 at risk EG0029 events4 affected16 at risk
Viral uveitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected16 at risk EG0020 events0 affected16 at risk
Arthropod sting	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected16 at risk EG0020 events0 affected16 at risk
Bone contusion	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0020 events0 affected16 at risk
Contusion	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0023 events2 affected16 at risk
Epicondylitis	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0021 events1 affected16 at risk
Meniscus injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected16 at risk EG0020 events0 affected16 at risk
Procedural pain	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events1 affected16 at risk EG0020 events0 affected16 at risk
Rib fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0020 events0 affected16 at risk
Upper limb fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0020 events0 affected16 at risk
C-reactive protein increased	Investigations	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0021 events1 affected16 at risk
Occult blood positive	Investigations	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0022 events2 affected16 at risk
Decreased appetite	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0021 events1 affected16 at risk
Diabetes mellitus	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0022 events2 affected16 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0021 events1 affected16 at risk
Hyperuricaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected16 at risk EG0023 events3 affected16 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0020 events0 affected16 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0020 events0 affected16 at risk
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0022 events2 affected16 at risk
Chondrocalcinosis pyrophosphate	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0021 events1 affected16 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected16 at risk EG0020 events0 affected16 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0012 events2 affected16 at risk EG0021 events1 affected16 at risk
Myalgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected16 at risk EG0020 events0 affected16 at risk
Neck pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected16 at risk EG0020 events0 affected16 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected16 at risk EG0010 events0 affected16 at risk EG0020 events0 affected16 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected16 at risk EG0011 events1 affected16 at risk EG0022 events1 affected16 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected16 at risk EG0020 events0 affected16 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0020 events0 affected16 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected16 at risk EG0020 events0 affected16 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events1 affected16 at risk EG0020 events0 affected16 at risk
Gastrointestinal submucosal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0021 events1 affected16 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0020 events0 affected16 at risk
Dementia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0020 events0 affected16 at risk
Dizziness	Nervous system disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected16 at risk EG0020 events0 affected16 at risk
Dysgeusia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0021 events1 affected16 at risk
Headache	Nervous system disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected16 at risk EG0022 events2 affected16 at risk
Memory impairment	Nervous system disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0020 events0 affected16 at risk
Post herpetic neuralgia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0021 events1 affected16 at risk
Progressive supranuclear palsy	Nervous system disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected16 at risk EG0020 events0 affected16 at risk
Anxiety	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected16 at risk EG0020 events0 affected16 at risk
Hypertonic bladder	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0020 events0 affected16 at risk
Pollakiuria	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0021 events1 affected16 at risk
Renal impairment	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected16 at risk EG0020 events0 affected16 at risk
Urinary retention	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected16 at risk EG0021 events1 affected16 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0021 events1 affected16 at risk
Chest discomfort	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0021 events1 affected16 at risk
Chest pain	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0020 events0 affected16 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected16 at risk EG0020 events0 affected16 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0020 events0 affected16 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0020 events0 affected16 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected16 at risk EG0020 events0 affected16 at risk
Blister	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0021 events1 affected16 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0020 events0 affected16 at risk
Dermatitis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events1 affected16 at risk EG0021 events1 affected16 at risk
Dry skin	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected16 at risk EG0021 events1 affected16 at risk
Eczema	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected16 at risk EG0020 events0 affected16 at risk
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected16 at risk EG0020 events0 affected16 at risk
Skin disorder	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0020 events0 affected16 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0020 events0 affected16 at risk
Subcutaneous emphysema	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0020 events0 affected16 at risk
Carotid artery stenosis	Vascular disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected16 at risk EG0020 events0 affected16 at risk
Dizziness postural	Vascular disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0013 events1 affected16 at risk EG0020 events0 affected16 at risk
Hypertensions	Vascular disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0014 events4 affected16 at risk EG0023 events3 affected16 at risk
Varicose vein	Vascular disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected16 at risk EG0020 events0 affected16 at risk
Acute myocardial infarction	Cardiac disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0021 events1 affected16 at risk
Angina pectoris	Cardiac disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0021 events1 affected16 at risk
Angina unstable	Cardiac disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected16 at risk EG0020 events0 affected16 at risk
Atrial fibrillation	Cardiac disorders	Systematic Assessment	EG0004 events2 affected16 at risk EG0010 events0 affected16 at risk EG0021 events1 affected16 at risk
Cardiac failure	Cardiac disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0021 events1 affected16 at risk
Cardiac failure chronic	Cardiac disorders	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected16 at risk EG0020 events0 affected16 at risk
Myocardial ischaemia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected16 at risk EG0021 events1 affected16 at risk

This was an exploratory study not powered to detect a difference in AAA diameter between the different study arms. Due to patient recruitment challenges, only 48 patients out of the 114 planned were enrolled and the study was shortened from 5 to 3 years. Due to the limited sample size potential confounders could also not be adjusted for.

Certain Agreements

ID	Term
D012907	Smoking
D017544	Aortic Aneurysm, Abdominal

ID	Term
D062789	Tobacco Products

Units	Counts
Participants	OG00016 OG00116 OG00216

Units	Counts
Participants	OG00016 OG00116 OG00216

Units	Counts
Participants	OG00016 OG00116 OG00216

Units	Counts
Participants	OG00016 OG00116 OG00216

OG0017.46(5.39 to 10.32)

OG0015.50(3.16 to 9.59)

OG0010.0(0.0 to 0.0)

OG0014.32(1.97 to 9.48)

OG0014.24(1.98 to 9.07)

OG0014.20(1.46 to 12.07)

OG001108.70(73.72 to 160.27)

OG00181.24(52.33 to 126.12)

OG00161.85(33.78 to 113.27)

OG00157.78(31.17 to 107.11)

OG00161.78(31.22 to 122.26)

OG00142.36(15.30 to 117.29)

OG0012.86(1.61 to 5.09)

OG0012.12(1.00 to 4.49)

OG0011.47(0.54 to 4.00)

OG0011.55(0.51 to 4.68)

OG0011.31(0.50 to 3.48)

OG0011.27(0.37 to 4.41)

OG001111.31(74.30 to 166.76)

OG0021.67(0.99 to 2.81)

OG00182.46(51.19 to 132.83)

OG0022.30(1.10 to 4.80)

OG00156.77(26.94 to 119.63)

OG0021.70(0.82 to 3.51)

OG00148.40(18.83 to 124.44)

OG0021.77(0.77 to 4.06)

OG00152.08(20.21 to 134.23)

OG0021.51(0.76 to 3.01)

OG00146.19(13.07 to 163.23)

OG0021.86(0.92 to 3.77)

ID	Term
D001519	Behavior
D001014	Aortic Aneurysm
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D001018	Aortic Diseases

ID	Term
D000074602	Smoking Devices
D008420	Manufactured Materials
D013676	Technology, Industry, and Agriculture