Administration Treatment will begin on the day after the baseline visit. The subjects will take a total of 1 tablet per day for the first 3 days of the dosing period. The dosing will then increase for the next 4 days to 2 tablets per day, 1 in the morning (the first blinded varenicline tablet) and 1 in the evening (the second blinded varenicline tablet). The dosing will then increase to 4 tablets per day, 2 in the morning (the first 2 blinded varenicline tablets) and 2 in the evening (the second 2 blinded varenicline tablets) for the remainder of the study. All subjects are to dose study medication on the day of the Week 1 visit in the morning prior to the visit. DOSING SHOULD OCCUR WITH 240 ML OF WATER AND IT IS RECOMMENDED THAT SUBJECTS EAT PRIOR TO DOSING. There must be at least 8 hours between the morning and evening dosing.