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The overall pattern and frequency of adverse events during the longer-term premarketing trials was similar to those described in Table 1, though several of the most common events were reported by a greater proportion of patients with long-term use (e.g., nausea was reported in 40% of patients treated with CHANTIX 1 mg twice daily in a one year study, compared to 8% of placebo-treated patients)

Acknowledgements We thank Maritta Bulancea, Mitch Lases, Wieny Kampinga, Noa Meijer, David Berger, Frouke de Vries, Eva Siebring and Stefan Bruins for their contributions to recruitment and the collection, transcription and analysis of all data

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Authors contributions RDK was the principal investigator on the study, all authers contributed to the study design