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Patients with serious psychiatric illnesses such as schizophrenia, bipolar disorder, and major depressive disorder did not participate in premarketing studies of varenicline, and the safety and efficacy of this drug in these patients has not been established

This nonsynonymous variant is within the alpha-5 nicotinic acetylcholine receptor ( CHRNA5 ) gene, and is strongly associated with smoking quantity and nicontine dependence in large-scale GWAS and functional studies [27, 49]

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