Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline ( CP-526,555) for the Maintenance of Smoking Cessation
Brief Summary: The primary purpose of this study is a comparison of abstinence maintenance in subjects randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded to an intial 12-week open label course of varenicline, with post-treatment follow-up of smoking status to Week 52.


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 cardiovascular disease in the past 6 months.
B: Inclusion Criteria:

* Current male or female cigarette smokers who are motivated to stop smoking.
* Smoked an average of 10 cigarettes per day during past year and the month prior to first visit.

Exclusion Criteria:

* Patients who have used a nicotine replacement product, bupropion, clonidine or notriptyline within the past 6 months.
* Patients currently with depression or diagnosed with depression in past 12 months.
* Past or present history of psychosis, panic disorder, or bipolar disorder.
C: Inclusion Criteria:

* Patients must be ≥ 18 years of age.
* Patient with newly diagnosed or recurrent, histologic diagnosis of any of the following tobacco related malignancies:

  1. Lung or Bronchus cancer or Head \& Neck, cancers (all sites).
  2. Esophagus, Stomach, Pancreas, Kidney, Urinary Bladder, Colon, Rectum, Cervix, Vulvar, Vaginal
  3. Carcinoma in situ undergoing definitive surgical resection or treatment (ex: radiation of the larynx, and gynecologic tract hysterectomy, vulvectomy - except gynecologic patients undergoing ablative or local excisional therapies \[laser ablation,cervical conization, LEEP\].
* Having smoked at least 1 cigarette within 4 weeks of study enrollment.
* Having at least a 10-pack year history of cigarette smoking.
* Having smoked at least one cigarette within 1 month of cancer diagnosis.
* Life expectancy is greater than 1 year.
* Patient has an AUDIT score of \< 10.
* Patient has ECOG Performance Status of \<=2.
* Patients must have the ability to understand and the willingness to provide signed written informed consent document.

Exclusion Criteria:

* Known allergy attributed to bupropion, varenicline, transdermal or lozenge nicotine.
* History of suicide attempt or preparation for attempt within the past 10 years.
* C-SRSS Baseline/Screening:

  1. Patient response of "Yes" to any question except question 1.
  2. Patient response of "Yes" to any question in column one (lifetime), except question 1, is not exclusionary unless judged by the investigator to be significant in ideation, intensity, behavior or attempts, and precludes participation.
* Hospitalized for psychiatric illness within the past two years.
* History of Bipolar disorder.
* Currently taking Bupropion for depression.
* Patient has taken monoamine oxidase inhibitors (MAOI) in the past two weeks.
* History of eating disorder such as anorexia or bulimia.
* Active widespread skin disorders such as psoriasis, chronic urticarial or dermatitis
* History of epilepsy or seizure disorder.
* Active severe kidney or liver disease.
* Women must not be pregnant or lactating. Women of reproductive-potential must have negative serum or urine pregnancy test within 7 days prior to study enrollment and agree to use method of contraception during and for 30 days following last cessation drug dose.
* Patients within three months of a myocardial infarction.
* Patients with unstable angina or serious arrhythmia.
* Patients with psychiatric disability judged by the investigator to be clinically significant so as to preclude informed consent or compliance with drug intake.
* Patient taking varenicline or bupropion within one month of study enrollment.
* Participation in any other investigational drug study within 4 weeks of study enrollment.
* Currently enrolled in other professional tobacco cessation therapeutic intervention.
* Enrollment in a concurrent cancer therapeutic trial will require prior review and approval by the study site PI to determine that there are no drug interactions concerns.
D: Inclusion Criteria:

* currently smoking at least 10 cigarettes per day (confirmed by high exhaled carbon-monoxide (CO))
* 18 years or older
* interested in quitting within the next 30 days
* one or more pre-defined medical illnesses (including cardiovascular disease, other vascular disease, chronic pulmonary disease, cancer, hypertension, diabetes, hyperlipidemia, and recurrent pulmonary infections)

Exclusion Criteria:

* contraindications to pharmacotherapy (including unstable angina, myocardial infarction within 2 months, severe arrhythmia, seizure disorder, serious mental illness requiring antipsychotic medications)
* current use of other tobacco products (smokeless tobacco, cigars, pipes, etc.), bupropion, clonidine, nortriptyline, or nicotine replacement medications
* unable to give consent

Answer: A