Comparison of Nicotine Plasma Concentrations and Subjective Effects for Three Menthol Electronic Cigarettes vs Combustible Menthol Cigarettes and Nicotine Gum

This study will assess various elements that may provide information regarding the potential
for menthol electronic cigarettes (e-cigarettes) to be adopted by current smokers. These
various elements include: a) nicotine pharmacokinetics (PK), b) physiological measures of
pulse rate and blood pressure, and c) subjective effects measured by Urge to Smoke, Urge for
Product, Product Rating, Intent to Use Product Again, and Product Effects.

Inclusion Criteria:

1. Able to read, understand, and willing to sign an informed consent form and complete
questionnaires written in English.

2. Generally healthy male or female, 21 to 60 years of age, inclusive, at Screening.

3. Expired breath carbon monoxide (ECO) level is ≥ 15 ppm and ≤ 100 ppm at the Screening
and Randomization Visits, measured between 12 p.m. and 6 p.m.

4. Combustible menthol cigarettes are the only tobacco product used within (≤) 30 days of
Screening.

5. Smokes combustible, filtered, menthol cigarettes, 83 mm to 100 mm in length.

6. Agrees to smoke usual brand (UB) menthol cigarette throughout the study period. Usual
brand cigarette is defined as the menthol cigarette brand style currently smoked most
frequently by the subject.

7. Smokes at least 10 menthol cigarettes per day (on average) and inhales the smoke, for
at least 6 months prior to Screening. Brief periods of abstinence due to illness, quit
attempt (prior to 30 days of Screening), or clinical study participation (prior to 30
days of Screening) will be allowed at the discretion of the Investigator.

8. Response at Screening to Fagerstrom Test for Nicotine Dependence, Question 1 ("How
soon after you wake up do you smoke your first cigarette?") is either "Within 5
minutes" or "6 - 30 minutes."

9. Willing to use UB menthol cigarette, the study electronic cigarette menthol brand
styles and nicotine gum during the study period.

10. Willing to abstain from tobacco and nicotine use for at least 12 hours prior to
check-in at each Test Visit.

11. Females of childbearing potential must be willing to use a form of contraception
acceptable to the Investigator from the time of signing informed consent until study
discharge.

Exclusion Criteria:

1. Clinically significant or unstable/uncontrolled acute or chronic medical conditions at
Screening, as determined by the Investigator, that would preclude a subject from
participating safely in the study (e.g., uncontrolled hypertension, asthma or other
lung disease, cardiac disease, neurological disease or psychiatric disorders) based on
safety assessments such as clinical laboratory tests, medical history, and
physical/oral examinations.

2. Systolic blood pressure of > 150 mmHg or a diastolic blood pressure of > 95 mmHg at
Screening, measured after being seated for at least 5 minutes.

3. Hemoglobin level is < 12 g/dL at Screening.

4. Positive test for Human Immunodeficiency Virus (HIV), Hepatitis B surface antigen, or
Hepatitis C virus.

5. Postponing a decision to quit smoking (defined as planning a quit attempt within [≤]
30 days of Screening) to participate in this study or previous attempt within (≤) 30
days prior to Screening.

6. Employed by a tobacco company, the study site, or handles unprocessed tobacco as part
of their job.

7. Use of any medication or supplement that aids smoking cessation, including but not
limited to any nicotine replacement therapy (e.g., nicotine gum, lozenge, patch),
varenicline (Chantix), bupropion (Wellbutrin, Zyban), or lobelia extract within (≤) 30
days of Screening.

8. Females ≥ 35 years of age currently using systemic, estrogen containing contraception
or hormone replacement therapy.

9. A positive urine drug screen without disclosure of corresponding prescribed
concomitant medication(s), at Screening or Randomization Visit. A positive alcohol
result at Screening, Randomization Visit, or at any Test Visit.

10. A female who is pregnant, lactating, or intends to become pregnant during the course
of the study.