Author Contributions: Dr Jorenby had full access to all of the data and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Watsky, Williams, Billing, Reeves.
Acquisition of data: Jorenby, Hays, Rigotti, Billing, Gong, Reeves.
Analysis and interpretation of data: Jorenby, Hays, Rigotti, Azoulay, Watsky, Williams, Billing, Gong, Reeves.
Drafting of the manuscript: Jorenby, Hays, Rigotti, Billing.
Critical revision of the manuscript for important intellectual content: Jorenby, Hays, Rigotti, Azoulay, Watsky, Williams, Billing, Gong, Reeves.
Statistical analysis: Jorenby, Watsky, Billing.
Obtained funding: Azoulay, Reeves.
Administrative, technical, or material support: Watsky, Williams.
Study supervision: Gong, Reeves.
Financial Disclosures: Dr Jorenby reported receiving research support from Pfizer, Nabi Biopharmaceutical, Sanofi-Aventis and consulting fees from Nabi Biopharmaceutical. Dr Hays reported receiving a research grant from Pfizer. Dr Rigotti reported receiving research grant funding and consulting fees from GlaxoSmithKline, which markets smoking cessation medications, and Pfizer and Sanofi-Aventis, which are developing smoking cessation medications. Dr Rigotti also reported receiving consulting fees from Merck, which is developing smoking cessation medications.
Independent Statistical Analyses: Daniel Bolt, PhD, associate professor of Educational Psychology at the University of Wisconsin, had access to all of the data used in the study and performed an independent analysis in consultation with Dr Jorenby. The independent statistical analyses involved the primary and key secondary outcomes, including participant demographics, self-reported data, and safety as described in this article. The results confirm what is presented in this article. Dr Bolt received compensation from the University of Wisconsin for this reanalysis.
Funding/Support: The data reported in this article were derived from a clinical trial sponsored by Pfizer Inc, which provided funding, study drug and placebo, and monitoring.
Role of the Sponsor: Drs Azoulay, Watsky, Williams, Gong, and Reeves, and Mr Billing, employees of Pfizer Inc, were involved in all elements of this study, including but not limited to the study design and monitoring. In addition, the database containing the findings of the 14 investigator sites was maintained by Pfizer Inc, and statistical analyses were performed at Pfizer Inc by Mr Billing and Ann Pennington, MS. All of the authors including those employed by Pfizer Inc, reviewed and edited the manuscript prior to publication of this article.
Varenicline Phase 3 Study Group: Beth Bock, PhD, Centers for Behavioral and Preventive Medicine, Miriam Hospital, Providence, RI; Arden G. Christen, DDS, MSD, Oral Health Research Institute, Indiana University School of Dentistry, Indianapolis; Larry I. Gilderman, MD, DO, University Clinical Research Incorporated, Pembroke Pines, Fla; Susanna K. Goldstein, MD, Medical and Behavioral Health Research, PC, New York, NY; J. Taylor Hays, MD, Mayo Clinic, Rochester, Minn; Thomas C. Jackson, MD, Outpatient Health Center, Aurora Sinai Medical Center, Milwaukee, Wis; Douglas E. Jorenby, PhD, Center for Tobacco Research and Intervention, University of Wisconsin Medical School, Madison; Barry J. Make, MD, National Jewish Research Center, Denver, Colo; Charles H. Merideth, MD, Affiliated Research Institute Inc, San Diego, Calif; Nancy A. Rigotti, MD, Tobacco Research and Treatment Center, Massachusetts General Hospital, Boston; David P. L. Sachs, MD, Division of Pulmonary and Critical Care, Stanford University School of Medicine, Palo Alto, Calif; Stephan C. Sharp, MD, Clinical Research Associates Inc, Nashville, Tenn; Susan H. Swartz, MD, Center for Tobacco Independence, Maine Medical Center, Portland; Mervyn U. Weerasinghe, MD, Rochester Clinical Research Inc, Rochester, NY.
Acknowledgment: Editorial support was provided by Kelly Stein Marcus, PhD, from Cardinal Health.