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The efficacy and safety of varenicline was evaluated in a randomized, double-blind, placebo-controlled study of 312 patients aged 12 to 19 years, who smoked an average of at least 5 cigarettes per day during the 30 days prior to recruitment, had a score of at least 4 on the Fagerstrom Test for Nicotine Dependence scale, and at least one previous failed quit attempt

State Violators may assert as a defense that: (1) the purchaser or recipient of the Restricted Product falsely represented, by producing a photo identification, that the purchaser or recipient was of legal age to make the purchase or receive the sample