Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 52-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety of Varenicline Tartrate ( CP-526,555) for Smoking Cessation
Brief Summary: The primary purpose of this study is to obtain safety information on cigarette smokers treated with 52 weeks of varenicline regardless of smoking status.


Options:
A: Inclusion Criteria:

* Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year.

Exclusion Criteria:

* Subjects with clinically significant, recent cardiovascular disease.
B: We are only recruiting by invitation only (to members of our past cohort). We will open up enrollment to the public in the Madison, WI and Milwaukee WI areas at the end of 2012.

Inclusion Criteria:

a. To be eligible for the Comparative effectiveness trial, participants must:

* smoke 5 or more cigarettes per day,
* desire to quit smoking but not be currently engaged in cessation treatment,
* be medically eligible to use either combination NRT or varenicline,
* have reliable phone access,
* if female, must not be pregnant and must be willing to use an acceptable birth control method.

Exclusion Criteria:

1. There are no exclusion criteria for participating in the main health outcomes study, other than being unwilling to complete study assessments.
2. All smoking participants from new and original cohorts will be excluded from the cessation trial for the following reasons:

   * end-stage renal disease with hemodialysis;
   * prior suicide attempts within the last 5 years or current suicidal ideation;
   * diagnosis of and/or treatment for schizophrenia;
   * other psychotic disorders or bipolar disorder within the last 10 years;
   * current PHQ-9 score indicative of moderately severe depression;
   * severe untreated hypertension \>200/100 mmHg;
   * currently taking Wellbutrin, Zyban or bupropion;
   * hospitalized for a stroke, heart attack, congestive heart failure or diabetes within the last year;
   * used pipe tobacco, cigars, snuff or chew more than twice in the past week.

It should be noted that if any incidental findings appear in any of the cardiology tests (e.g., ultrasound, tonometry, ECG, or exercise stress test; see forms in Supplemental Information section of application), the study cardiologist (Dr. Stein or his designee) will be assign the participant to the non-randomized treatment arm and they will be given the nicotine patch and the same counseling intervention as CET participants. They will not be included in the CET analyses. This will be done to properly address the cardiovascular risk warning from the FDA regarding varenicline (Chantix).
C: Inclusion Criteria:

* Non-Hispanic African American or non-Hispanic White
* ≥ 18 years of age
* Smoked 3-20 cigarettes per day
* Smoked on \>25 days of the past 30 days
* Functioning telephone
* Interested in quitting smoking
* Interested in taking 3 months of varenicline
* Willing to complete all study visits

Exclusion Criteria:

* Renal impairment
* Evidence or history of clinically significant allergic reactions to varenicline
* A cardiovascular event in the past month Hospitalization in the past 2 months for any cardiovascular disease, including but not limited to:

  * Angina
  * Myocardial infarction
  * Peripheral vascular disease
  * Stroke
* New onset of chest pain or arrhythmia in the past 2 months
* History of alcohol or drug dependency in the past year
* Major depressive disorder in the last year requiring treatment
* History of panic disorder, psychosis, bipolar disorder, or eating disorders
* Use of tobacco products other than cigarettes in past 30 days
* Use of pharmacotherapy in the month prior to enrollment, including prior use of varenicline
* Pregnant, contemplating getting pregnant, or breastfeeding
* Plans to move from Kansas City during the treatment and follow-up phase
* Another household member enrolled in the study
D: Inclusion Criteria:

* Male or female daily smokeless tobacco users aged 18 years and older, who are motivated to stop use of all tobacco products.
* Subjects must be daily users of nicotine containing smokeless tobacco and using smokeless tobacco on at least 8 occasions per day averaged over a week.
* Have used smokeless tobacco for at least 1 year prior to screening with no period of abstinence \>3 months in the past year.

Exclusion Criteria:

* Subjects using nicotine containing products (including smoking tobacco) other than smokeless tobacco for 3 months prior to screening.
* Subjects with exhaled Carbon Monoxide (CO) \>10 ppm at baseline.
* Subjects who have used varenicline, bupropion, or NRT within 3 months of screening.
* Subjects currently or within the past 12 months requiring treatment for depression or have a current or prior history of panic disorder, psychosis, bipolar disorder or any other serious mental illness.

Answer: A