Efficacy and Safety Following Use of a Novel Nicotine Replacement Therapy

Efficacy and Safety Following Use of a Novel Nicotine Replacement Therapy. A Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group, 52 Week Study in Smokers Motivated to Quit.

A comparison of a novel nicotine replacement therapy and placebo treatment in smokers motivated to quit smoking.

Efficacy and safety study following use of a novel nicotine replacement therapy.

Inclusion Criteria:

• 18 years or older male and female cigarette smokers motivated and willing to stop smoking
• Female participants of child-bearing potential should use a medically acceptable means of birth control.
• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study and consents to participate.

Exclusion Criteria:

• Unstable angina pectoris or myocardial infarction during the previous 3 months.
• Pregnancy, lactation or intended pregnancy (non-pregnancy will be verified by urine pregnancy test for female participants of child-bearing potential).
• Participation in other clinical trials within the previous three months and during study participation.