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Methods/design Study design This clinical trial will use a double-blind, placebo-controlled, dose escalation design, with random assignment of participants to an experimental (group A) and a control condition (group B) for 10 weeks after failure to achieve abstinence during an open-label run-in period of approximately 2 weeks using a 21-mg nicotine patch daily

Quitting is a gradual process, as it is not easy to achieve and can lead to anxiety and depression due to withdrawal from nicotine

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