Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of an Electronic Nicotine Delivery Device (ENDD) on Smoking Cessation and Reduction: a Pilot Study
Brief Summary: The study's major aim is to investigate the ability of a commercial Electronic Nicotine Delivery Device (ENDD) to induce long-term smoking reduction/abstinence in smokers unwilling to quit. Secondary aims are to monitor adverse events and measure participants' perception and acceptance of the product.

This pilot study will evaluate smoking reduction/abstinence effects, product preferences, and adverse events of a currently marketed device in Italy ("Categoria" electronic cigarette - "ORIGINAL" 7.2 mg nicotine cartridges). The primary hypothesis is that the E-Cigarette is a safe device that allows smoking reduction or abstinence in smokers.


Options:
A: Inclusion Criteria:Healthy smokers 18-60 years old, smoking ≥15 conventional cigarettes per day (cig/day) for at least 10 years were recruited using anti-smoking leaflets and by an approved kiosk located in the atrium of the university hospital (AOU 'Policlinico-V. Emanuele') promoting the smoking cessation services of the CPCT (Centro per la Prevenzione e Cura del Tabagismo, Università di Catania, Italy).

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Exclusion Criteria:history of alcohol and illicit drug use, major depression or other psychiatric conditions. We also excluded subjects who reported recent myocardial infarction, angina pectoris, essential hypertension (\>140mmHg systolic and/or \>90mmHg diastolic), diabetes mellitus, severe allergies, poorly controlled asthma or other airways diseases

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B: Inclusion Criteria:

* healthy smokers
* unwilling to quit
* age 18-60 years
* smoking ≥ 15 cig/day for at least 5 years
* exhaled CO level of ≥ 15 ppm
* FTND ≥ 5

Exclusion Criteria:

* alcohol and illicit drug use
* breastfeeding or pregnancy
* major depression or other psychiatric conditions
* previous experience with ENDD
* recent myocardial infarction
* angina pectoris
* high blood pressure (BP\>140mm Hg systolic and/or 90mmHg diastolic)
* diabetes mellitus
* severe allergies
* poorly controlled asthma or other airways diseases
C: Inclusion Criteria:

1. Smokers smoking at least 10 cigarettes/day (factory made or roll-your-own) in the past year
2. Aged 18 to 70 years
3. Motivated to quit defined as a score \> 5 on a visual rating scale ranging from 0 (not motivated at all) to 10 (extremely motivated)
4. Signed written informed consent
5. Understanding and speaking French
6. Women of childbearing age can be included if they use an effective contraceptive method: either hormonal contraception or an intrauterine device started at least one month before the first research visit
7. Individual affiliated to a health insurance system as defined by the sponsor (except Aide Médicale d'État =AME)
8. Previous failure of nicotine replacement therapy for smoking cessation

Exclusion Criteria:

1. any unstable disease condition within the last 3 months defined by the investigator as major change in symptoms or treatments such as 1.1.recent myocardial infarction, 1.2.unstable or worsening angina 1.3.severe cardiac arrhythmia 1.4.unstable or uncontrolled arterial hypertension 1.5.recent stroke 1.6.cerebrovascular disease 1.7.obliterative peripheral arterial disease 1.8.cardiac insufficiency 1.9.diabetes 1.10.hyperthyroidism 1.11.pheochromocytoma 1.12.severe hepatic insufficiency 1.13.history of seizures 1.14.severe depression 1.15.chronic obstructive pulmonary disease (COPD)
2. any life threatening condition with life-expectancy of less than 3 months
3. alcohol use disorder defined as a score ≥ 10 on the AUDIT-C questionnaire
4. abuse of or dependence on illegal drugs in the last 6 months revealed by the medical history
5. regular use of tobacco products other than cigarettes
6. current or previous (last 6 months) use of electronic cigarette
7. pregnant women
8. breastfeeding women
9. protected adults
10. current or past 3 months participation in another interventional research
11. current or past (last 3 months) use of smoking cessation medication such as varenicline, bupropion, nicotine replacement therapies
12. known lactose intolerance (placebo tablets contain lactose)
13. hypersensitivity to the active substance or to any of the excipients
14. known severe renal failure
D: Inclusion Criteria:

1. Subjects involved in the early lung cancer detection program (Cosmos II) of the European Institute of Oncology.
2. Subjects should have smoked at least 10 cigarettes a day for the past 10 years
3. Subjects that would like to reduce tobacco smoking but are not willing to be followed by a smoking center
4. To have an high motivational scoring (more than 10 points to the motivation questionnaire);
5. Signed informed consent

Exclusion Criteria:

1. symptomatic severe cardiovascular disease
2. symptomatic severe respiratory disease
3. regular psychotropic medication use
4. current or past history of alcohol abuse
5. use of smokeless tobacco or nicotine replacement therapy
6. pregnancy or breastfeeding.
7. Subjects involved in other antismoking program in the current year.

Answer: B