Prolonged abstinence from tobacco smoking during the last 4 weeks of treatment (Day 43 to Day 70) as reported by direct inquiry of the patient by the Investigator, and confirmed by exhaled carbon monoxide (CO) levels, and plasma cotinine measurements. [clinicaltrials_resource:e8484667822d00f629d7184e5e20e32c]

Prolonged abstinence from tobacco smoking during the last 4 weeks of treatment (Day 43 to Day 70) as reported by direct inquiry of the patient by the Investigator, and confirmed by exhaled carbon monoxide (CO) levels, and plasma cotinine measurements. [clinicaltrials_resource:e8484667822d00f629d7184e5e20e32c]