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 |