Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 12-Week, Double-Blind, Placebo-Controlled, Multicenter Study With A 40 Week Follow Up Evaluating the Safety and Efficacy of Varenicline Tartrate 1 Milligram (Mg) Twice Daily (BID) for Smoking Cessation in Subjects With Cardiovascular Disease
Brief Summary: The primary purpose of this study is to determine whether or not varenicline will help people with cardiovascular disease quit smoking and to confirm it is safe in these patients.


Options:
A: Inclusion Criteria:

* Outpatients, over legal age, smoking at least 10 cigarettes/day as a mean within the 2 months preceding the screening visit.

Exclusion Criteria:

* Patients who have taken an investigational drug within the past six months prior to the screening visit.
* Patients who had a previous quit attempt (= or \>1 day with the aid of pharmacological adjunct) in the previous three months (before screening).
* Patients who have smoked or consumed non-tobacco cigarettes or any form of tobacco product (other than cigarettes such as cigars, pipes, smokeless tobacco, etc) more than 3 times within the 3 months preceding the screening visit.
* Patients who currently present with (based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition \[DSM-IV\]):

  * Psychotic disorder
  * Major depressive episode
* Pregnant or breast-feeding women.
* Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy. Medically acceptable methods of birth control for this study include approved hormonal contraceptive medications or devices, approved intra-uterine contraceptive devices, use of two combined barrier methods.
* Patients who have suffered from a myocardial infarction, unstable angina or other major cardiovascular event within the past week prior to screening.
* Patients who have a history of multiple allergic reactions to medications in two drug classes.
* Patients who have QTcF \> 500 ms on the electrocardiogram (ECG).
* Patients with mild, moderate or severe renal impairment.
* Patients who have an abnormal laboratory test of potential clinical significance at screening.
B: Inclusion Criteria:

* Age 18 or older
* English speaking
* Smoked at least 100 cigarettes/lifetime
* Smokes 5 or more cigarettes per day
* Interested in quitting smoking (preparation or contemplation state of change)
* Enrolled in Einstein/Montefiore methadone program for 3 or more months
* Stable methadone dose for 2 weeks
* Agree to use contraception throughout the trial (among women with reproductive potential)
* Willing to participate in all study components
* Able to provide informed consent

Exclusion Criteria:

* Serious or unstable HIV/AIDS, liver, cardiovascular, or pulmonary disease
* Psychiatric instability
* Women who are pregnant, breastfeeding, or contemplating pregnancy
* Creatinine clearance less than 30 mL/min
C: Inclusion Criteria:

* Smokes greater than 20 cigarettes per day

Exclusion Criteria:

* History of Parkinson's disease, high blood pressure, or severe liver or kidney disease
* Current substance abuse
* Mental illness
* Skin conditions that could interfere with patch use
* Using antidepressant medications (e.g., levodopa/carbidopa, methyldopa, or any MAO inhibitor)
* Pregnant or breastfeeding
D: Inclusion Criteria:

* Participants must have stable, documented cardiovascular disease (including at least one of the following diagnosed \> 2 months prior to the Screening visit - angina, myocardial infarction (MI), revascularization, transient ischemic attack (TIA), and peripheral vascular disease (PVD).
* Participants that smoke \> 10 cigarettes / day.

Exclusion Criteria:

* Participants with unstable cardiovascular disease
* Cardiovascular events in the past 2 months
* Moderate or severe chronic obstructive pulmonary disease (COPD)

Answer: D