Author Contributions: Dr Gonzales had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Gonzales, Nides, Billing, Watsky, Williams, Reeves.
Acquisition of data: Gonzales, Rennard, Nides, Oncken, Billing, Gong, Reeves.
Analysis and interpretation of data: Gonzales, Rennard, Nides, Azoulay, Billing, Watsky, Gong, Williams, Reeves.
Drafting of the manuscript: Gonzales, Rennard, Nides, Oncken, Billing.
Critical revision of the manuscript for important intellectual content: Gonzales, Rennard, Oncken, Azoulay, Billing, Watsky, Gong, Williams, Reeves.
Statistical analysis: Gonzales, Billing.
Obtained funding: Azoulay, Watsky, Reeves.
Administrative, technical, or material support: Gonzales, Rennard, Watsky, Williams.
Study supervision: Azoulay, Watsky, Gong, Reeves.
Financial Disclosures: Dr Gonzales reports having received research contracts from Pfizer, Sanofi-Aventis, GlaxoSmithKline, and Nabi Biopharmaceuticals; consulting fees and honoraria from Pfizer, Sanofi-Aventis, and GlaxoSmithKline; and owning 5 shares of Pfizer stock. Dr Rennard reports having had or currently having a number of relationships with companies who provide product and/or services relevant to outpatient management of chronic obstructive pulmonary disease. These relationships include serving as a consultant for Adams, Almirall, Altana, Array Biopharma, AstraZeneca, Aventis, Biolipox, Centocor, Dey, Critical Therapeutics, GlaxoSmithKline, Johnson & Johnson, Merck, Novartis, Ono Pharma, Otsuka, RJ Reynolds, Roche, Sankyo, Schering-Plough, Scios, and Wyeth; advising regarding clinical trials for Altana, AstraZeneca, Aventis, Centocor, GlaxoSmithKline, Novartis, Pfizer, and Philip Morris; and speaking at continuing medical education programs and performing funded research both at basic and clinical levels for Altana, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, and Novartis. Dr Nides reports having received research grants, consulting fees, and honoraria from Pfizer, Sanofi-Aventis, and GlaxoSmithKline. Dr Oncken reports having received research grants, consulting fees, and honoraria from Pfizer; receiving, at no cost, nicotine replacement and placebo products from GlaxoSmithKline for smoking cessation studies; and receiving honoraria from Pri-Med. Drs Azoulay, Watsky, Gong, Williams, and Reeves and Mr Billing report owning Pfizer stock or having stock options in Pfizer.
Funding/Support: This study was supported by Pfizer Inc, which provided funding, study drug and placebo, and monitoring.
Role of the Sponsor: The database containing the findings of the 19 individual investigator sites was maintained by Pfizer Inc, and statistical analyses were performed at Pfizer Inc by Mr Billing and by Ann Pennington, MS.
Independent Statistical Analysis: Barbara Pizacani, PhD, Adjunct Faculty at the School of Nursing at Oregon Health & Science University (OHSU) and Epidemiologist in Program Design and Evaluation Services for Multnomah Health Department and Orgeon Department of Human Services, and Clyde Dent, PhD, of the Program Design and Evaluation Services of Multnomah County Health Department and Oregon Department of Human Services, had access to all of the data used in the study and performed an independent analysis in consultation with Dr Gonzales. The independent analysis replicated the analyses of the primary and secondary end points reported in the manuscript using cross tabulations, logistic regression, and mixed-model procedures. Repeat tabulations for other end points were performed. Results for the adverse events were also replicated. Results were comparable with those obtained by the sponsor. While there were several small discrepancies, all were resolved prior to submission of the manuscript and none affected the inferences made in the manuscript. Compensation for Drs Pizacani and Dent was provided by OHSU. Pfizer Inc provided no funds to support the independent analysis.
Varenicline Phase 3 Study Group: Lirio S. Covey, PhD, Social Psychiatry Research Institute, New York, NY; Jeffrey George Geohas, MD, Radiant Research, Chicago, Ill; Elbert D. Glover, PhD, Department of Public and Community Health, University of Maryland, College Park; Jon F. Heiser, MD, Pharmacology Research Institute, Newport Beach, Calif; Kevin Lawrence Kovitz, MD, Tulane University Health Sciences Center, New Orleans, La; Lawrence Vincent Larsen, MD, PhD, Intermountain Clinical Research, Salt Lake City, Utah; Myra Lee Muramoto, MD, University of Arizona Health Sciences, Tucson; Barry Packman, MD, Radiant Research, Philadelphia, Pa; Victor Ivar Reus, MD, University of California, San Francisco; Howard I. Schwartz, MD, Miami Research Associates Inc, Miami, Fla; Arunabh Talwar, MD, North Shore University Hospital, Great Neck, NY; Martin Lewis Throne, MD, Radiant Research, Atlanta, Ga; Dan Louis Zimbroff, MD, Pacific Clinical Research Medical Group, Upland, Calif.
Acknowledgment: We thank Wendy G. Bjornson, MPH, OHSU, for her contribution to the development of the manuscript and Kelly Stein Marcus, PhD, Cardinal Health, for providing medical editorial review and assisting with incorporating revisions from the authors and developing tables and figures.