The studies that were included in the analyses for this manuscript were supported by Pfizer Inc., which provided funding for the trials, study drug and placebo and monitoring. Statistical analyses were conducted by Dr Arteaga, at Pfizer. Dr Pizacani, Adjunct Faculty at the School of Nursing at Oregon Health & Science University (OHSU) and Epidemiologist in Program and Evaluation Services for Multnomah County Health Department and Oregon Department of Human Services, and Dr Dent, Professor Emeritus, University of Southern California Keck School of Medicine, Adjunct Professor at Portland State University School of Community Health and Epidemiologist in Program Design and Evaluation Services of Multnomah County Health Department and Oregon Department of Human Services, had access to all the data used in the study and performed an independent analysis in consultation with Dr Gonzales. The independent analysis replicated the analyses reported in the manuscript. 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. Dr Gonzales had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Compensation for Drs Pizacani and Dent was provided by OHSU. Pfizer, Inc. provided no funds to support the independent analysis. Each of the authors contributed to the conception and design of the study; interpreted the data; drafted and revised the article for content; and approved the final version for publication. Editorial support in the form of medical editorial review, assistance with incorporating revisions from the authors and developing tables and figures was provided by Brenda Smith PhD, UBC Scientific Solutions, and was funded by Pfizer Inc. Study sites and Principal Investigators for the Varenicline Phase 3 Study Groups were: Gonzales et al. JAMA
]: Lirio S. Covey PhD, Social Psychiatry Research Institute, New York, NY; Jeffrey George Geohas MD, Radiant Research, Chicago, III; Elbert D. Glover PhD, Department of Public and Community Health, University of Maryland, College Park; David Gonzales PhD, OHSU Smoking Cessation Center, Oregon Health & Science University, Portland, OR; Jon F. Heiser MD, Pharmacology Research Institute, Newport Beach, CA; Kevin Lawrence Kovitz MD, Tulane University Health Sciences Center, New Orleans, LA; Lawrence Vincent Larsen MD, PhD, Intermountain Clinical Research, Salt Lake City, UT; Myra Lee Muramoto MD, University of Arizona Health Sciences, Tucson, AZ; Mitchell Nides PhD, Los Angeles Clinical Trials, Los Angeles, CA; Cheryl Oncken MD, Department of Medicine, University of Connecticut Health Center, Farmington, CT; Barry Packman MD, Radiant Research, Philadelphia, PA; Stephen I. Rennard MD, Pulmonary Division, University of Nebraska Medical Center, Omaha, NE; Victor Ivar Reus MD, University of California, San Francisco, CA; Howard I. Schwartz MD, Miami Research Associates Inc., Miami, FL; 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, CA. Jorenby et al
]: 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, IN; Larry I. Gilderman, MD, DO, University Clinical Research Incorporated Pembroke Pines, FL; Sussana K. Goldstein MD, Medical and Behavioral Health Research, PC, New York, NY; J. Taylor Hays MD, Mayo Clinic, Rochester, MN; Thomas C. Jackson MD, Outpatient Health Center, Aurora Sinai Medical Center, Milwaukee, WI; Douglas E. Jorenby PhD, Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, WI; Barry J. Make MD, National Jewish Research Center, Denver, CO; Charles H. Merideth MD, Affiliated Research Institute Inc, San Diego, CA; Raymond Niaura PhD, Brown University, Providence, RI; Nancy A. Rigotti MD, Tobacco Research and Treatment Center, Massachusetts General Hospital, Boston, MA; David P. L. Sachs MD, Division of Pulmonary and Critical Care, Stanford University School of Medicine, Palo Alto, CA; Stephan C. Sharp MD, Clinical Research Associates Inc, Nashville, TN; Susan H. Swartz MD, Center for Tobacco Independence, Maine Medical Center, Portland, ME; Mervyn U. Weerasinghe MD, Rochester Clinical Research Inc, Rochester, NY. Portions of the results have been reported at scientific meetings such as the Society of Research on Nicotine and Tobacco Europe Meeting, Madrid, Spain, 4 October 2007 and Annual Meeting, Portland, Oregon USA, 1 March 2008; and the UKNSCC meeting, Birmingham, UK, 30 June 2008.