The placebo-controlled ORCA-2 study evaluated the safety and efficacy of cytisinicline as a treatment for smoking cessation in 810 adult smokers.
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N-nitroso-varenicline may be associated with an increased cancer risk based on data from closely related nitrosamine compounds.
Results from a placebo-controlled study evaluating Chantix (varenicline; Pfizer) in pediatric patients 12-16 years of age showed that the smoking cessation treatment was not associated with a significant increase in abstinence rates in this patient population.
The use of electrical stimulation devices (ESDs) to treat self-injurious or aggressive behavior has been banned by the Food and Drug Administration (FDA).