Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Twelve-Week Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of a Flexible-Dosing Strategy for CP-526,555 ( 0.5 mg to 2.0 mg Total Daily Dose ) in Smoking Cessation
Brief Summary: The purpose of the study was to measure the safety and efficacy of a 12-week flexible dosing strategy of CP-526,555 compared with placebo for smoking cessation. Post-treatment follow-up of smoking status to one year from randomization was performed in a non-treatment extension Protocol A3051019


Options:
A: Inclusion Criteria:

* Patients smokers (= 10 cigarettes per day in the last year)
* Affected by a chronic obstructive pulmonary disease.
* Presenting a recent exacerbation having led to at least a 24-hour hospitalization in pneumology or intensive care unit.
* Inclusion during hospitalization.
* Motivated to quit smoking
* Able to understand the information and give a written consent.
* Available for a follow-up of 1 year.

Exclusion Criteria:

* Refusal or unable to consent.
* Unaffiliated or not entitled to the National Health Insurance Coverage.
* Absence of a chronic obstructive pulmonary disease according to the criteria ATS / ERS.
* presenting a contraindication to the pharmacotherapy (i.e. the active substance: tartrate of varénicline or one of the excipients)
* actively participating in other smoking cessation trials.
* Pregnancy: declared or planned in 14 months.
* breastfeeding.
* Women old enough to procreate without reliable contraception.
* History of anorexia nervosa or bulimia.
* History of a severe depression and having required a medicinal treatment in 5 years.
* History of 2 or several episodes of severe depression and having required a medicinal treatment.
* Personal or family History of suicide attempt.
* History or current presence of dementia, a bipolar disease, a psychosis, a panic attack.
* Taken by psychotropic medicines in the inclusion excepted those prescribed to hypnotic aim and antidepressant medicine of the class of the inhibitors of the recapture of the sérotonine prescribed for a not severe depression
* Presence of a depression detected by means of the questionnaire HAD (not inclusion if the total of the sub-scale D is \> 8 or if the total of scales A + D is \> 16) and/or PHQ-9 (not inclusion if score \> 9).
* SGOT or SGPT \> 2 fold upper limit of normal, the hepatic cirrhosis, the acute hepatitis.
* Renal insufficiency (clearance of the creatinine \< 30 ml / min according to the formula of Cockcroft).
* Excessive consumption of alcohol (more than 21 glasses a week for the men, more than 14 glasses of wines a week to them Women).
* Use of marijuana or other forms of tobacco during the study.
* Use of other stimulant drugs (ephedrine, phenylephrine) or appetite suppressants during the study.
* Life expectancy of ≤ 12-months (ex: patients affected by a chronic disease in terminal phase).
B: Subject inclusion criteria

1. DSM IV-TR Bipolar I or II or Bipolar NOS Disorder
2. Ability to provide written informed consent
3. Male or Female patients, all races, ages 18 to 65 years inclusive
4. Negative serum pregnancy test for females of child-bearing potential. Patients must agree to one of the following birth control methods: an oral contraceptive agent, an intrauterine device (IUD), an implantable contraceptive (e.g., Norplant), or an injectable contraceptive (e.g., Depo Provera) 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 a barrier method of contraception, e.g., condom and/or diaphragm with spermicide while participating in the study through at least 30 days after the last dose of study medication or abstinence.
5. MADRS total scores ≤ 8 (past 4 weeks) (suicidal item, score ≤ 1, past 4 weeks).
6. Y-MRS scores ≤ 8 (past 4 weeks) irritability, speech content, disruptive, or aggressive behavior items score ≤ 3, past 4 weeks)
7. Stable doses of primary bipolar maintenance medication for at least 8 weeks prior to randomization
8. No psychiatric hospitalization or Emergency Room Visits for psychiatric issues in the 6-month period prior to randomization
9. No suicidal attempts or behavior history past 6 months
10. No aggressive or violent acts or behavior by history past 6 months

Subject exclusion criteria

1. Uncontrolled seizure disorders and other neurological disorders including Huntington's Chorea, Multiple Sclerosis, Cerebral Palsy, and stroke (cerebrovascular accident, CVA).
2. Current alcohol or other substance abuse or dependence within the last 3 months (caffeine will be permitted, nicotine dependence is part of inclusion criteria), including a case-by-case evaluation of those who meet remission criteria and who are on long-term substance abuse and/or alcohol abuse treatment.
3. Female patients who are pregnant, lactating or likely to become pregnant in next 6 months
4. Uncontrolled diabetes mellitus, asthma, seizure disorder, uncontrolled hypertension, (uncontrolled hypertension is defined as Systolic BP \> 150 mm or Hg or diastolic BP \> 95 mm or Hg on 2 consecutive BP readings 15 minutes apart at the time of screening) or unstable medical illness. Moderate to severe renal disease - moderate renal failure is defined as serum Creatinine \>1.3 mg/dl in women and \> 1.5 mg/dl in men, at the time of screening.
5. Severe dizziness or fainting due to orthostatic blood pressure changes
6. Known hypersensitivity to varenicline
7. Current use of cimetidine
8. Current treatment with heparin, warfarin, or lidocaine
9. Comorbid psychiatric condition diagnosed within the last three months.

Subject smoking inclusion criteria

1. Score of 7 or greater on the Contemplation Ladder, and willing to pick a target quit date within the next 4 weeks.
2. Smoke \> 10 cigarettes per day.
3. Expired breath CO level \> 10 ppm at screening and randomization.
4. No use of smoking cessation medication and/or behavioral treatment for smoking cessation in the past three months.
5. No current use of any nicotine replacement treatment.
6. Not using any tobacco products other than cigarettes.
7. No current treatment for smoking cessation (hypnosis, acupuncture, others).
8. No current use or past treatment failure with varenicline.
9. No current treatment with bupropion for smoking cessation.
C: Inclusion Criteria:

* Subjects must have smoked an average of at least ten cigarettes per day during the past year
* No period of abstinence greater than three months in the past year

Exclusion Criteria:

* Subjects with history of clinically significant cardiovascular disease
* Subjects with uncontrolled hypertension.
D: Inclusion Criteria:

* Smoking population attending to the Smoking Cessation Unit of "Virgen del Rocío" University Hospital.
* Subjects \>18 years old who want to give up smoking.
* Android-based smart phone availability.
* Ability to interact with the smart phone.
* To sign an Informed Consent Form.

Exclusion Criteria:

* Subjects had some previous adverse effects related to the pharmacological treatment included in the study

Answer: C