Author Contributions: Dr Pi-Sunyer 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: Pi-Sunyer, Aronne, Heshmati.
Acquisition of data: Pi-Sunyer, Aronne, Heshmati, Rosenstock.
Analysis and interpretation of data: Pi-Sunyer, Aronne, Heshmati, Devin, Rosenstock.
Drafting of the manuscript: Pi-Sunyer, Aronne.
Critical revision of the manuscript for important intellectual content: Aronne, Devin, Rosenstock.
Statistical analysis: Devin.
Obtained funding: Pi-Sunyer.
Administrative, technical, or material support: Pi-Sunyer, Heshmati, Rosenstock.
Study supervision: Aronne, Heshmati, Rosenstock.
Financial Disclosures: Drs Pi-Sunyer and Aronne have received honoraria from Sanofi-Aventis for speaker's presentations. No other authors reported financial disclosures.
Funding/Support: RIO-North America was supported by a research grant from Sanofi Synthelabo Research, a division of Sanofi Synthelabo Inc, a member of the Sanofi-Aventis group.
Role of the Sponsor: Sanofi-Aventis participated in discussions regarding study design and protocol development and the sponsor provided logistical support for the trial, data collection, and data analysis, and helped in preparing the manuscript. The sponsor was permitted to review the manuscript, but the final decision on content was with the corresponding author in conjunction with the other authors.
Independent Statistical Review: All study data were transferred from Sanofi-Aventis to the Department of Medicine at St Luke's-Roosevelt Hospital Center for independent reanalysis by Stanley Heshka, PhD. Statistical reanalyses of the raw data were performed by Dr Heshka. There were no discrepancies between the reanalysis and the original interpretation of the results and conclusions. In lieu of financial compensation for Dr Heshka's time and effort in performing the statistical analyses, an unrestricted educational grant from Sanofi-Aventis was given to the Obesity Research Center at St Luke’s-Roosevelt Hospital Center in New York, NY.
Data and Safety Monitoring Board: Alain Leizorovicz, MD (chairman), Université Claude Bernard, Lyon, France; Michael Weintraub, MD, University of Rochester School of Medicine and Dentistry, Rochester, NY; Jean-Louis Imbs, MD, Hôpital Civil, Strasbourg, France; Elliot Danforth, MD, University of Vermont, Burlington; David P. L. Sachs, MD, Palo Alto Center for Pulmonary Disease, Palo Alto, Calif.
RIO North America Investigators:Canada (Ontario): Denis Callaghan, Hamilton; Jeff Daiter, Richmond Hill; John Nuttall, Kingston; William O’Mahony, Corunna; Duncan Sinclair, Aylmer; Donald Spink, Peterborough; Paul Willoughby, Woodstock; Paul Ziter, Windsor. United States: Andrew Ahmann, Portland, Ore; James Anderson, Lexington, Ky; Louis Aronne, New York, NY; Richard Atkinson, Madison, Wis; Michael Basista, Bloomfield, NJ; Kathleen Baskett, Missoula, Mont; Harold Bays, Louisville, Ky; Gregory Bishop, San Diego, Calif; Scott Bleser, Bellbrook, Ohio; Marshall Block, Phoenix, Ariz; Stephen Brady, Naples, Fla; Ronald Brazg, Renton, Wash; Robert Call, Richmond, Va; Antonio Caos, Ocoee, Fla; Harry Collins, South Plainfield, NJ; Gordon Connor, Birmingham, Ala; Martin Conway, Albuquerque, NM; Lydia Corn, Sarasota, Fla; Walter Dunbar, Atlanta, Ga; Ronald Emkey, Wyomissing, Pa; James Ferguson, Salt Lake City, Utah; Harold Fleming, Spartanburg, SC; Nicholas Fleming, Spartanburg, SC; Arthur Frank, Washington, DC; Ken Fujioka, San Diego, Calif; Sidney Funk, Atlanta, Ga; Elizabeth Gallup, Overland Park, Kan; W. Thomas Garland, Lawrenceville, NJ; Jeffrey Geohas, Chicago, Ill; Eric Goldberg, West Palm Beach, Fla; Frank Greenway, Baton Rouge, La; Paula Hall, Indianapolis, Ind; Wayne Harper, Raleigh, NC; Scott Horn, San Antonio, Tex; Roy Kaplan, Concord, Calif; Richard Krause, Chattanooga, Tenn; Diane Krieger, Miami, Fla; Roberta Loeffler, Wichita, Kan; Barry Lubin, Norfolk, Va; Thomas Marbury, Orlando, Fla; Clark McKeever, Houston, Tex; James McKenney, Richmond, Va; Curtis Mello, Swansea, Mass; Neerja Misra, Lawrenceville, NJ; Patrick O’Neil, Charleston, SC; F. Xavier Pi-Sunyer, New York, NY; David Podlecki, Longmont, Colo; Gary Post, Highlands Ranch, Colo; R. Walter Powell, Newark, Del; Stephen Rafelson, Langhorne, Pa; Kenneth Rictor, Scotland, Pa; Julio Rosenstock, Dallas, Tex; Daniel Rowe, West Palm Beach, Fla; John Rubino, Raleigh, NC; Donald Schumacher, Charlotte, NC; Douglas Schumacher, Columbus, Ohio; Howard Schwartz, Miami, Fla; Simona Scumpia, Austin, Tex; Stephan Sharp, Nashville, Tenn; Earl Shrago, Madison, Wis; Diane Smith, Augusta, Ga; Norman Soler, Springfield, Ill; Paul Tung, Dover, NH; Greggory Volk, Beavercreek, Ohio; Ralph Wade, Salt Lake City, Utah; Richard Weinstein, Walnut Creek, Calif; Todd Wine, Oceanside, Calif; Lisa Wright, Birmingham, Ala; John Zerbe, Cincinnati, Ohio; Douglas Zmolek, Manlius, NY.
Previous Presentation: Presented in part at the American Heart Association's Scientific Sessions, New Orleans, La, November 7-10, 2004.
Acknowledgment: We appreciate the expert assistance of Stanley Heshka, PhD (St Luke’s-Roosevelt Hospital Center, Columbia University, New York, NY) in conducting an independent statistical analysis of the study data and in providing guidance on appropriate statistical methods.