Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 26-Week Phase II, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Varenicline in Combination With Nicotine Replacement Therapy for Smoking Cessation
Brief Summary: The purpose of this study is to test whether the addition of a nicotine patch to varenicline increases smoking cessation success rate and whether the combination is safe.


Options:
A: Light smokers (6-15 cigarettes per day

Inclusion Criteria:

Mentally and physically stable, non-pregnant, light smokers (6-15 cigarettes per day)

Exclusion Criteria:

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B: Inclusion Criteria:

1. Current cigarette smokers, male and female, aged between 18-75 years (both limits inclusive), and who are motivated to stop smoking.
2. Have smoked on average at least 10 cigarettes per day during past year and during the month prior to screening, and no period of abstinence greater than 3 months in the past year.
3. Women of child-bearing potential (WCBP) may be included provided they are not pregnant, not nursing, and meet all of the following criteria:

   * instructed and agree to avoid pregnancy through 30 days after the last dose of study medication
   * negative screening test (beta-HCG) at screening
   * agree to use at least one birth control method (oral contraceptive, IUD, implantable or injectable contraceptive for at least 1 month prior to entering the study and will continue its use through at least 30 days after the last dose of study medication, or use a barrier method of contraception (p.e.condom, diaphragm with spermicide) while participating in the study through at least 30 days after the last dose of study medication; or abstinence.
4. Patients must have no serious or unstable disease in the past 6 months.
5. Patients must be able to be outpatients, to be assessed in a clinical setting, and be able and willing to comply with all study visits during the treatment and non-treatment periods.
6. Only one subject per household may participate.

Exclusion Criteria:

1. Patients currently suffering from depression or who have been diagnosed with depression or treated with anti-depressants within the past 12 months.
2. Patients with a past of present history of psychosis, panic disorder, or bipolar disorder.
3. Patients with severe chronic obstructive pulmonary disease (COPD).
4. Patients with clinically significant cardiovascular disease in the past 6 months. such as myocardial infarction, coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA), severe or unstable angina, serious arrhythmia, and clinically significant ECG conduction abnormalities.
5. Patients with uncontrolled hypertension or a systolic blood pressure greater than 150mmHg or as diastolic pressure greater than 95mmHg at screening or baseline.
6. Patients with clinically significant neurological disorders or cerebrovascular diseases (for example, stroke, transient ischemic attack, etc.) in the past 6 months.
7. Patients with a history of clinically significant endocrine disorders or gastrointestinal diseases, including insulin dependent diabetes mellitus, uncontrolled hyperthyroidism, and active peptic ulcer.
8. Patients with clinically significant hepatic or renal impairment or other clinically significant abnormal laboratory test values.
9. Patients with a history of cancer (cured basal cell or squamous cell carcinoma of the skin allowed).
10. Patients with a history of clinically significant allergic reactions to drugs (for example, severe cutaneous and/or systemic allergic reactions).
11. Patients with a history of drug (except nicotine) or alcohol abuse or dependence within the past 12 months.
12. Patients with a body mass index (BMI) less than 15 or greater than 38 when wearing indoor clothing without shoes. No subject will be enrolled with a weight less than 45.5kg (100 pounds).
13. Patients previously enrolled in a study that included varenicline.
14. Patients having used nicotine replacement therapy within the last 6 months.
15. Patients taking another investigational drug within 30 days or 5 half-lives (whichever is longer) before the Baseline visit or within 30 days of study completion.
16. Use of prohibited medications: any antidepressants, including bupropion; antipsychotic agents; mood stabilizers; naltrexone; steroids (inhaled and topical steroids are permitted); insulin.
17. Patients who do not agree to completely abstain from using non-cigarette tobacco products (including for example, pipe tobacco, cigars, snuff, chewing tobacco, etc.) or marijuana during study participation.
18. Patients who intend to donate blood or blood components while receiving study drug or within 1 month of the completion of the study treatment.
19. Patients unable/or unlikely to comprehend and follow the study protocol, including patients unable and/or unwilling to participate in the non-treatment follow-up. Patients who, in the investigator's opinion, will be unlikely to commit to a 6 month-long study.
20. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
C: Inclusion Criteria:

Asthmatic symptoms during the last year and at least one criterion of the below:

1. current FEV1-increase of minimum 12% after b2-agonist,
2. positiv Methacholintest,
3. Day-to-day FEV1-variation of at least 20% during a two-week period.
4. Positive mannitol test.

Furthermore, all of the below inclusion criteria:

* At least 10 packyears
* At least 10 cigarettes per day within the last year
* Age 18-40 years

Exclusion Criteria:

1. Asthmatics who have been treated with inhaled corticosteroids (ICS), systemic corticosteroids, leukotrien-antagonists (LTA), long-lasting b2-agonists, anticholinergic medicine or varenicline within the last 3 months
2. Lower respiratory tract infections, including pneumonia, within the last 6 weeks.
3. Patients suffering from other chronic respiratory disease than asthma, such as sarcoidosis and COPD will also be excluded.
4. Pregnant and nursing women will be excluded as well as women planning pregnancy during the study period.
5. A history of allergy towards study drugs will lead to exclusion.

Patients who during the study period develop lower respiratory infections or due to severe uncontrolled asthma receive treatment with any of the above listed types of medicine will be excluded. Patients who are diagnosed with other chronic respiratory disease than asthma during the study period will also be excluded, as well as patients who during the study period require more asthma medicine than the planned study medication.

Any participant who wishes to leave the study, for any reason, including unacceptable side-effects, during the study period will be excluded, as well as anyone who wants to withdraw their recorded data from the project after the study period has ended.

In case of unacceptable side-effects to varenicline resulting in immediate cessation of treatment with this drug, the participant will continue visits unchanged, but he/she will be excluded from the calculations of tobacco cessation succes-rate. However, varenicline cessation up to 4 weeks after treatment start with varenicline will result in exclusion and replacement of the participant.

Cessation of treatment with budesonide will result in exclusion from the rest the study. The person will not be replaced. The data recorded from the participant until the last visit before cessation will be used.

Allergic reactions towards study drugs will result in immediate cessation of the drug, and possible exclusion, as described in the above.

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D: Inclusion Criteria:

* Smoke at least 10 cigarettes per day for the previous 6 months - Expired CO \> 9 ppm - Motivated to quit smoking - Able to read and write English - Willing to complete required study assessments

Exclusion Criteria:

* Uncontrolled hypertension (systolic \>180mm Hg or diastolic \>110mm Hg) - History of bipolar disorder or psychosis - Myocardial infarction or other serious cardiac problem in the previous 4 weeks - History of diagnosed anorexia and/or bulimia - Diagnosis of Alcohol Dependence in the previous 6 months by participant self-report or drinking 6 or more drinks on six or more days a week - History of seizure and/or serious head injury involving loss of consciousness - Use of contraindicated medications (MAO inhibitors, bupropion, lithium, anticonvulsants, antipsychotics) - Currently pregnant or breast-feeding - Unwilling to use effective contraception during the treatment phase - More than one participant from the same household - Allergic reactions to 3 or more classes of drugs

Answer: B