Randomized Study Comparing the Efficacy and Safety of Varenicline Tartrate to Placebo in Smoking Cessation When Subjects Are Allowed to Set Their Own Quit Date

The percentage of participants who reported complete abstinence from cigarette smoking and other nicotine use (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO) >10 parts per million (ppm) at any visits Week 9 through Week 12. A participant was considered a responder if they met the following criterion: said they had not smoked or used nicotine products 'since the last visit' and did not have CO >10 ppm.

Percentage of participants with CA from cigarette smoking and other nicotine-containing (treatment phase) or tobacco (non-treatment phase) products use, who did not have CO >10 ppm at any visits Week 9 through Week 24. A participant was considered a responder if they met the following criterion: said they had not smoked or used nicotine products 'since the last visit' and did not have CO >10 ppm.

Responder for the primary endpoint of CA from Week 9 through Week 12 and who had no more than 6 days of smoking during the non-treatment phase of the study. For Weeks 13, 16, 20, and 24, long term quit was determined by CO-confirmed in-clinic visit.

Percentage of participants with complete abstinence from cigarette smoking or other nicotine-containing (treatment phase) or tobacco (non-treatment phase) products use for the 7 days prior to Week 12 and Week 24, respectively, who did not have CO >10 ppm at any visits. CO-confirmed in-clinic visit.

Percentage of participants with complete abstinence from cigarette smoking or use of tobacco products for the 4 weeks prior to Week 24 who did not have CO >10 ppm at any visits.

Change in nicotine dependence from baseline to the date of the FQA within the first 5 weeks. FTND was designed to provide an ordinal measure of nicotine dependence related to cigarette smoking. It contains items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. The FTND contains 4 yes-no and 2 multiple choice questions and can be used in a self-report format. The items on FTND are scored 0 to 3 for multiple choice items, the items are summed to yield a total score of 0-10 (0=minimum nicotine dependence; 10=maximum nicotine dependence).