Study concept and design: Croghan, Schroeder, Hurt, Ebbert.
Acquisition of data: Hatsukami, Croghan, Allen, Hays, Hurt.
Analysis and interpretation of data: Hatsukami, Croghan, Schroeder, Hurt, Ebbert.
Drafting of the manuscript: Hatsukami, Croghan, Ebbert.
Critical revision of the manuscript for important intellectual content: Hatsukami, Croghan, Schroeder, Allen, Hays, Hurt.
Statistical analysis: Schroeder.
Obtained funding: Hurt, Ebbert.
Administrative, technical, or material support: Croghan, Hays, Hurt.
Study supervision: Hatsukami, Croghan, Allen, Ebbert.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Ebbert reports serving as an investigator for clinical trials funded by Pfizer, receipt of consultancy fees from GlaxoSmithKline, research support from Pfizer, and research support from Orexigen and JHP Pharmaceuticals outside of the current study. Dr Hatsukami reports receipt of research support from Nabi Biopharmaceuticals outside of the current study. Dr Hays reports serving as an investigator for clinical trials funded by Pfizer. Dr Hurt reports receipt of consulting fees from Pfizer, an unrestricted grant from Pfizer Medical Education Group, and provision of expert testimony in Florida tobacco litigation cases. The other authors report no disclosures.
Funding/Support: The clinical trial was supported by National Institutes of Health (NIH) grant CA 138417 (primary investigator, Dr Ebbert). Medication (varenicline) was provided by Pfizer.
Role of the Sponsors: NIH and Pfizer had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.