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Long-term nicotine replacement therapy: cancer risk in context

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Sensitivity and specificity for self-reported smoking status were calculated using a cotinine cut-off estimated from the study population (30 nmol/l)

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The PMTA pathway requires applicants to submit extensive scientific evidence demonstrating that permitting the marketing of their new tobacco product would be appropriate for the protection of public health. This involves detailed studies on product chemistry, manufacturing consistency, toxicological profiles, health impacts on users and non-users, and the likelihood of youth initiation versus adult smoker cessation