Published Online: November 13, 2006 (doi:10.1001 /jama.296.21.joc60158).
Author Contributions: Dr Meyer 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. Dr Meyer performed an independent statistical analysis, and all of the results shown in this article reflect his work.
Study concept and design: Mazzone, Meyer, Feinstein, Kondos, D’Agostino, Perez, Provost, Haffner.
Acquisition of data: Mazzone, Perez, Provost.
Analysis and interpretation of data: Mazzone, Meyer, Davidson, D’Agostino, Perez, Provost, Haffner.
Drafting of the manuscript: Mazzone, Kondos, D’Agostino, Perez, Haffner.
Critical revision of the manuscript for important intellectual content: Mazzone, Meyer, Feinstein, Davidson, D’Agostino, Perez, Provost, Haffner.
Statistical analysis: Mazzone, Meyer, Feinstein, Davidson, D’Agostino, Provost, Haffner.
Obtained funding: Mazzone, Perez.
Administrative, technical, or material support: Mazzone, Perez, Provost.
Study supervision: Mazzone, Kondos, Perez, Provost.
Financial Disclosures: Dr Mazzone reports serving as a consultant for Amylin, Merck, Novartis, Pfizer, and Takeda and receiving speaking honoraria from Merck, Novartis, Pfizer, and Takeda. Dr Meyer reports serving as a consultant for Takeda. Dr Feinstein reports serving as a consultant for Kos and Takeda. Dr Davidson reports serving as a consultant for Abbott, AstraZeneca, Kos, Merck, Merck/Schering-Plough, Novartis, Pfizer, Reliant, Roche, Sankyo, Sumitomo, and Takeda; serving on the speaker's bureau for Abbott, AstraZeneca, Kos, Merck, Merck/Schering-Plough, Pfizer, Reliant, Sankyo, and Takeda; and receiving grants/research support from Abbott, AstraZeneca, Bristol-Myers Squibb, Kos, Merck, Merck/Schering-Plough, Novartis, Pfizer, Reliant, Roche, Sankyo, and Takeda. Dr Kondos reports serving as a consultant for, and receiving grants/research support and honoraria from, Takeda. Dr D’Agostino reports serving as a consultant for Bayer, Pfizer, Sanofi, and Takeda. Dr Perez reports that he is a employed by Takeda Global Research and Development. Dr Provost reports that he is employed by Synarc. Dr Haffner reports serving as a consultant for AstraZeneca, GlaxoSmithKline, Merck Sharpe & Dohme Ltd, Pfizer, and Takeda and receiving grants/research support from Novartis and Pfizer.
Funding/Support: Takeda Pharmaceuticals North America Inc, Lincolnshire, Ill, sponsored and funded this study and provided the study drugs. Work on this study also was supported by National Heart, Lung, and Blood Institute (NHLBI) grant K25 HL68139-01A1 to Dr Meyer.
Role of the Sponsors: Takeda Global Research & Development Inc, Lincolnshire, Ill, participated in protocol development and in the development and review of the manuscript and also oversaw participant recruitment, study conduct, collection of study data. The NHLBI had no role in the design and conduct of the study; the collection, analysis, and interpretation of the data; or the preparation, review, or approval of the manuscript.
CHICAGO Steering Committee: Theodore Mazzone (Principal Investigator), George Kondos (University of Illinois at Chicago); Peter Meyer (Rush Presbyterian-St Luke's Medical Center, Chicago, Ill); Steven Feinstein, Michael Davidson (Rush University Medical Center, Chicago); Ralph D’Agostino, Sr (Boston University, Boston, Mass); Alfonso Perez (Takeda Global Research & Development, Lincolnshire, Ill); and Steven Haffner (University of Texas Health Science Center at San Antonio).
CHICAGO Site Investigators: Dennis C. Abella, DO (Radiant Research Alexian Brothers, Elk Grove Village, Ill); Frank O. Apantaku, MD (Illinois Center for Clinical Research, Chicago); Leon Fogelfeld, MD (Cook County Hospital, Division of Endocrinology, Chicago); Michael Davidson, MD (Radiant Research, Chicago); Richard A. Margolin, MD (Midwest Physicians Group, Homewood, Ill, and Accelovance, Crestwood, Ill); Bernard J. Mizock, MD (Peryam and Kroll Healthcare Research, Chicago); Gary P. Plundo, DO (Accelovance, Orland Park, Ill); Jeffrey G. Shanes, MD (Consultants in Cardiovascular Medicine, Melrose Park, Ill); Waldo Harvey, Jr, MD (ICCT Research International Inc, Chicago); Azazuddin A. Ahmed, MD (American Medical Research Inc, Chicago); Richard Bertenshaw, Jr, MD (LaGrange, Ill); Judy A. Carter, MD (Oak Park Hospital, Oak Park, Ill); Lee S. Freedman, MD (Highland Park, Ill); Daniel H. Litoff, MD (Harbor Medical Group, Chicago); Shishir Jain, MD (Personal Physicians, Cicero, Ill); Neil B. Perlman, MD (Westlake Medical Associates, Vernon Hills, Ill); Alan D. Kogan, MD (Evanston, Ill, and North Suburban Cardiology Group Ltd, Arlington Heights, Ill); Betul A. Hatipoglu, MD (University of Illinois at Chicago); Thomas L. Pitts, MD (Chicago, Ill); Audisho B. Khoshaba, MD (ABK Medical Center Ltd, Chicago); Reuben T. Nichols, MD (Midlake Medical Corporation, Chicago); Steven M. Malkin, MD (Medical Care Group Ltd, Arlington Heights, Ill); Danny Sugimoto, MD (Cedar-Crosse Research Center, Chicago); Santosh Gill, MD (Fox Valley Clinical Research Center, Aurora, Ill); Antonio Barajas, MD (Family Practice, Chicago); Arnold F. Turner, MD (Prairie Medical Associates Ltd, Chicago); James G. Cunnar, MD (DuPage Family Medicine, Naperville, Ill); and Albert Reynolds, MD (South Suburban Health Professional Group, Flossmoor, Ill).
Members of the Clinical Events Committee: William Gaasch, MD (Lahey Clinic, Burlington, Mass); I. K. Jang, MD (Massachusetts General Hospital, Boston); Ajit B. Raisinghani, MD, Ori Ben-Yehuda, MD (UCSD Medical Center, San Diego, Calif); Theo Meyer, MD (University of Massachusetts Medical Center, Worcester).
Members of the Data and Safety Monitoring Board: Edward Horton, MD (Boston, Mass): George Bakris, MD (Rush-Presbyterian-St Luke's Medical Center, Chicago, Ill); Sidney Goldstein, MD (Henry Ford Hospital, Detroit, Mich); Barry Davis, MD, PhD (University of Texas School of Public Health, Houston); and Spencer King, MD (Atlanta, Ga).
Imaging Core Laboratory: Laure Arnaud, Arnaud Marmorat, Armelle Merle, PhD, Jean-Claude Provost, MD, and Laurence Torcel (Synarc, Paris, France); Ales Linhart, MD (sonographer training) (Charles University, Praha, Czech Republic).
Acknowledgment: The authors thank Stephanie Thompson, University of Illinois, for manuscript preparation. Ms Thompson received no compensation for her contributions.