Published Online: March 25, 2007 (doi:10.1001/jama.297.12.1344).
Author Contributions: Dr Crouse 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: Crouse, Raichlen, Evans, Palmer, O’Leary, Grobbee, Bots.
Acquisition of data: Riley, Palmer, Bots.
Analysis and interpretation of data: Crouse, Raichlen, Evans, Palmer, Grobbee, Bots.
Drafting of the manuscript: Crouse, Raichlen, Palmer, Bots.
Critical revision of the manuscript for important intellectual content: Crouse, Raichlen, Riley, Evans, Palmer, O’Leary, Grobbee, Bots.
Statistical analysis: Evans, Palmer, Bots.
Obtained funding: Crouse.
Administrative, technical, or material support: Riley, Palmer, O’Leary.
Study supervision: Crouse, Raichlen, Riley, Grobbee.
Financial Disclosures: Dr Crouse reported receiving grant or salary support from Merck, Merck-Schering Plough, Pfizer, AstraZeneca, and Kos Pharmaceuticals; and giving lectures for Merck, Merck-Schering Plough, Pfizer, AstraZeneca, Abbott, and Kos Pharmaceuticals. Dr Raichlen reported being an employee of AstraZeneca. Dr Riley reported receiving research contracts from AstraZeneca, Organon, and Pfizer. Mr Evans reported receiving grant support and honoraria from AstraZeneca, Organon, and Pfizer; and being a consultant to AstraZeneca and Pfizer. Dr Palmer reported being an employee of AstraZeneca. Dr O’Leary reported being on data and safety monitoring boards for Pfizer and AstraZeneca; being a consultant to Pfizer, Sankyo Pharma, Sanofi-Aventis, GlaxoSmithKline, Eli Lilly, Schering-Plough, Esperion Therapeutics, and Merck; and being an equity partner in Imagepace LLC. Dr Grobbee reported receiving grant support from and delivering lectures for Pfizer, AstraZeneca, Organon, Servier, and Merck. Dr Bots reported receiving study grants for studies on carotid intima-media thickness and/or honoraria for professional input on carotid intima-media thickness issues from AstraZeneca, Icelandic Heart Foundation, Organon, Pfizer, the Netherlands Heart Foundation, the Netherlands Organisation for Health Research and Development, Servier, and Unilever.
Funding/Support: The METEOR study was funded by AstraZeneca.
Role of the Sponsor: The sponsor participated in discussions regarding the design and conduct of the study and provided logistical support during the trial. Monitoring of the study and maintenance of the trial was performed by a contract research organization, Medpace, under contract with the sponsor. Collection, management, and analysis of the data were performed by the sponsor and the contract research organization under contract with the sponsor. The manuscript was prepared by the authors of this article. The sponsor was permitted to review the manuscript and suggest changes but the final approval of content was exclusively retained by the authors.
Independent Statistical Analysis: Mr Evans performed an independent statistical analysis with full access to the study data, protocol, and analysis plan and in consultation with Dr Palmer. The analyses included primary and secondary outcomes and safety data described in the article. Mr Evans' findings confirmed the results originally obtained by Dr Palmer and it was not necessary to alter the manuscript in any respect. Mr Evans' effort for these activities was paid for by Wake Forest University without compensation from AstraZeneca.
METEOR Investigators:Belgium: Marcelo Goldstein (Anderlecht); Jan Staessen and Guy Marchal (Leuven). Czech Republic: Ales Linhart (Prague). Finland: Jukka T. Salonen (Kuopio). France: Alain Simon (Paris Cedex); Patrick Audouy, Charles Baranes, Jean-Philippe Brugnaux, Daniel Delbecq, Andre Sebbah, Eric De Ste Lorette, Pascal Didi (Paris); Eric Chabaud (Ivry sur Seine); Jean Claude Mouchet (Meudon); Gilles Bertrand and Alain Prochasson (Metz); Marcel Frohn (Moutiers); Jean-Luc Jacques (Mars la Tour); Dominique Richter (Jarney); Jean-Louis Doubet and Serge Kownator (Thionville); Philippe Martin (Yutz); Jean-Claude Ingrand and Albert Cohen (Les Lilas); Denis Smila (Yerres); Genevieve Arcizet and Karima Allouache (Bangolet); Mohamed Oulmekki (Drancy). Germany: Raimund Erbel (Essen); Clemens Von Shacky (Munich). Norway: Leiv Ose, Olyvind Aabo, Jon Christensen, Anne C. Poole, David Russell (Oslo); Knut Risberg (Skedsmokorset); Andreas Tandberg (Bekkestua). the Netherlands: Annette Bak (Utrecht); Jan Jonker (Rotterdam). United States: California: Robert Davidson and Tasneem Z. Naqvi (Los Angeles); Laurence Yellen and Margaret Drehobl (San Diego); Monica Perlman and Shirley Otis (La Jolla). Illinois: Michael Davidson, Bernard Mizok, Zane P. Osborne, Steven Feinstein (Chicago). Minnesota: Alan Hirsch, Stephen Glasser, Leslie Miller, Daniel Duprez, Donald Hunninghake (Minneapolis); Norman M. Lunde (Brooklyn Center). North Carolina: Thomas W. Littlejohn and John R. Crouse III (Winston-Salem); Cecil Farrington (Salisbury). Ohio: Evan Stein, Eli Roth, Dean Kereiakes, Stephen Pomeranz (Cincinnati). Pennsylvania: David M. Capuzzi, John Morgan, Laurence Needleman (Philadelphia); Daniel Edmundowicz, Alan Gradman, Kim Sutton-Tyrell (Pittsburgh). Texas: Charles McCollum, Christie Ballantyne, William Insull (Houston). Washington: Robert Knopp and Kirk Beach (Seattle); David Cameron (Kirkland). Wisconsin: Neville Bittar and James Stein (Madison).
CIMT Core Laboratory:Europe: Vascular Imaging Center, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands (Anne-Marie Bos, Michiel Bots, MD, PhD [cochair], Corine van Everdingen, Marrij Geurtsen, Frank Leus, Corry Loffveld, Rudy Meijer, MSc, Dicky Mooiweer-Bogaerdt, Karin Nijssen, BSc [cochair], Hannie Noordzij, Anneke Rutgers, Els Stooker, Brigitte van der Vlist, Lucienne van der Vlist, Arthur Waterschoot, Elise Wineke, Harry Wisse). United States: School of Medicine, Wake Forest University, Winston-Salem, NC (Gregory Evans, MA, Ward Riley, PhD [cochairs], Kerstin Bettermann, MD, Dan Brewer, Anne Conner-Day, Teresa Crotts, Barbara Ettenger, Cindy Halverson, Billie Holley, Tina Hooker, Lois Hoots, Kimberly Lane, Patricia Miller, Suzanne Pillsbury, Susan Saunders, Connie Sharpe, Mitzie Spainhour, Jeanette Stafford, MS, Linda Trimarchi, Charles Tegeler, MD, Melanie Wilder, Bo Xiao).
Acknowledgment: We thank Catherine Harmston (Prime Medica Ltd), who provided editing assistance and was paid by AstraZeneca; Helena Melezinkova, MD (AstraZeneca), who monitored adverse events in Europe, and Joseph Neubauer (AstraZeneca), who provided administrative support of the trial and study supervision, both were compensated by AstraZeneca as part of their salaries. We also thank the Covance Central Laboratory Services Inc (Indianapolis, Ind, and Geneva, Switzerland).