Please select the eligibility criteria that correspond to the clinical trial below.
Title: Flexibly-Dosed Combination Pharmacotherapy Versus Standard-Dosed Nicotine Patch Alone for Smokers With Medical Illness
Brief Summary: Randomized clinical trial to evaluate a flexibly-dosed-3-medication combination for up to 6 months in smokers with medical illness


Options:
A: Inclusion Criteria:

* Subjects must have smoked an average of at least 15 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:

1. HIV positive
2. Adult (aged 18 or older)
3. Current smoker (more than 5 cigarettes per day)
4. Willing to set a date to quit smoking within the next 2-4 weeks
5. Currently on ART with an undetectable HIV viral load
6. Able to read/speak English or French
7. Able to provide written, informed consent as approved by the Ottawa Health Science Network Research Ethics Board and REBs at participating HIV clinic sites

Exclusion Criteria:

1. Contraindications to nicotine replacement therapy such as allergy to adhesive, serious cardiac arrhythmias (e.g., tachycardia), or vasospastic disease (e.g., Buerger's disease, Prinzmetal's variant angina)
2. Contraindications to varenicline such as hypersensitivity to varenicline or to any ingredient in the formulation or component of the container.
3. Reported previous severe intolerances to nausea or gastrointestinal symptoms.
4. Pregnant, lactating or planning to become pregnant during the study period or refuses a serum beta-HCG test.
5. Current severe renal impairment or currently taking Cimetidine
6. Previous or current seizure disorder and/or is taking anti-epileptic drugs
7. Psychosis and/or is taking anti-psychotic drugs
8. Diagnosed with severe major depressive episode requiring hospitalization within the past 12 months, previous psychiatric inpatient admission for any cause within the past 12 months, suicide attempt within the past 12 months active or current suicidal ideations as assessed by the BDI-II.
9. Current use of bupropion, varenicline or any nicotine replacement therapy.
10. Use of substances (e.g., crack cocaine) that would interfere with a participant's ability to adhere to the study schedule; determined by site coordinator's discretion.
C: 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
D: 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.

Answer: C