Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Controlled, 2-arm Parallel Group, Multi-center Study, to Evaluate Biological and Functional Changes in Healthy Smokers Switching to Tobacco Heating System 2.2 (THS 2.2) Compared to Continuing Smoking Conventional Cigarettes for 26 Weeks in an Ambulatory Setting
Brief Summary: The aim of the study is to demonstrate clinical, biological and functional health changes in smokers switching to the candidate modified risk tobacco product: Tobacco Heating System 2.2 (THS 2.2) as compared to smokers continuing smoking their conventional cigarettes (CC) over a 26-week period.

To characterize the study as successful, at least 5 clinical risk endpoints should move in the direction of smoking cessation and these results would be statistically significant. The main analysis will be defined a priori (using the Hailperin-Ruger approach) and will be made between THS 2.2 use and CC use as "per actual product used" and product use categories.


Options:
A: Inclusion Criteria:

* Current healthy smoker as judged by the Principal Investigator(s) or designee(s)
* Minimum age: 30 years old
* Have smoked for the last 10 years
* Have smoked more than 10 non menthol CC/day on average (no brand restriction) over the past year

Exclusion Criteria:

* Clinically relevant medical conditions that in the opinion of the investigators would jeopardize the safety of the participant.
* Subject who has (FEV1/FVC) \< 0.7 and FEV1 \< 80% predicted value at post-bronchodilator spirometry
* Subject with asthma condition (post-bronchodilator FEV1/FVC \< 0.75 and reversibility in FEV1 ≥ 12% and \> 200 mL from pre- to post-bronchodilator values)
* Subject who took or is taking concomitant medication which may have an impact on the "smoker's heath profile"
* Female subject is pregnant or breast feeding.
* Female subject who does not agree to use an acceptable method of effective contraception.
B: Inclusion Criteria:

* Smoking, apparently healthy subject as judged by the Investigator.
* Subject smokes at least 10 commercially available mCCs per day (no brand restrictions) for the last 4 weeks, based on self-reporting.
* Subject has smoked for at least the last 3 consecutive years.
* Subject does not plan to quit smoking within the next 6 months.

Exclusion Criteria:

* As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason).
* The subject has received medication within 14 days or within 5 half-lives of the medication (whichever is longer), which has an impact on CYP1A2 or CYP2A6 activity.
* For women: Subject is pregnant or is breast feeding.
* For women: Subject does not agree to use an acceptable method of effective contraception.
C: Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the study:

1. Able to comply with the study procedures
2. Male or female healthy smokers aged ≥19
3. Smoking at least 10 cigarettes a day
4. Smoking for at least one year
5. Not currently attempting to quit smoking or wishing to do so in the next 30 days (this will be verified at screening by the answer ''NO'' to both questions ''Do you intend to quit in the next 30 days?'' and ''Are you interested in taking part in one of our smoking cessation programs?'')
6. Female smokers not planning to become pregnant are using an acceptable form of contraception.

Exclusion Criteria:

The presence of any of the following will exclude a subject from study enrolment:

1. Use of smokeless tobacco, or any other tobacco products (including e-cigarettes, cigars, chewing tobacco, snus, etc.) within the last 3 months, at baseline and during the whole study.
2. Use of nicotine replacement therapy or other smoking cessation therapies within the last 3 months and at baseline.
3. Self-reported pregnancy, planned pregnancy or breastfeeding.
4. Tobacco industry employees and 1st degree relatives will be excluded in order to safeguard independence of the study

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D: Inclusion Criteria:

* Subject is aged ≥ 21 years.
* Subject is Caucasian.
* Subject is healthy, as judged by the Investigator.
* Subject smokes at least 10 commercially available non-menthol CCs per day (no brand restrictions) for at least the last 6 weeks prior to admission, based on self-reporting.
* Subject has smoked at least for the last 3 years.
* Subject does not plan to quit smoking in the next 3 months.

Exclusion Criteria:

* As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason).
* Subject has received medication within 14 days or within 5 half-lives of the medication (whichever is longer), which has an impact on cytochrome P450 1A2 (CYP1A2) or cytochrome P450 2A6 (CYP2A6) activity.
* Female subject is pregnant or breast feeding.
* Female subject does not agree to use an acceptable method of effective contraception.

Answer: A