Table 1– Inclusion and exclusion criteria
Inclusion criteriaExclusion criteria
Males and females, 18 yrs or older
Daily cigarette smoker for the last 3 yrs or more (no lower limit in number of daily cigarettes)
Expired carbon monoxide level of at least 10 ppm after at least 15 smoke-free min
Motivated and willing to completely stop smoking from the day after the baseline visit and to stay smoke-free
Willing to use study drug for at least 12 weeks
Female participants of child-bearing potential to use a medically acceptable method of birth control
Evidence of a personally signed and dated informed consent document
Willing and able to comply with all study procedures and attend 11 scheduled visits during the 52-week study
Willing and able to use an eDiary, according to the instructions provided, and willing to return the eDiary at the 12-week visit
Current use of tobacco-containing products, other than cigarettes, or smoking other substances
Use of other NRT, or bupropion or varenicline, or any other treatment for tobacco dependence (e.g. acupuncture)
Unstable angina pectoris or myocardial infarction or stroke during the previous 3 months
Pregnancy, lactation or intended pregnancy
Suspected alcohol or drug abuse
Another member of the same household who is already a subject in the current trial
Participation in any other clinical trial within the previous 3 months, or during the current trial
Any acute or chronic medical or psychiatric condition or previously diagnosed renal or hepatic disease that may increase the risk associated with study participation
Presence of an oral lesion (suspected malignant lesion and/or erosive lesion) that required further investigation, such as biopsy
  • The text for inclusion and exclusion criteria is appropriately abbreviated. NRT: nicotine replacement therapy.