Author Contributions: Drs Nicholls and Nissen and the Cleveland Clinic Coordinating Center for Clinical Research had full and independent access to all of the data in the study, and Dr Nicholls takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Nicholls, Krueger, Wang, McErlean, Nissen.
Acquisition of data: Wang, McErlean.
Analysis and interpretation of data: Nicholls, Brewer, Kastelein, Krueger, Wang, Shao, Hu, McErlean, Nissen.
Drafting of the manuscript: Nicholls, Wang, Nissen.
Critical revision of the manuscript for important intellectual content: Nicholls, Brewer, Kastelein, Krueger, Wang, Shao, Hu, McErlean, Nissen.
Statistical analysis: Shao, Hu.
Obtained funding: Nicholls, Nissen.
Administrative, technical, or material support: McErlean.
Study supervision: Krueger.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Nicholls reports receiving research support from AstraZeneca, Novartis, Eli Lilly, Anthera, LipoScience, Roche, and Resverlogix and receiving honoraria or serving as a consultant for AstraZeneca, Roche, Esperion, Abbott, Pfizer, Merck, Takeda, LipoScience, Omthera, Novo-Nordisk, sanofi-aventis, Atheronova, Anthera, CSL Behring, and Boehringer Ingelheim. Dr Brewer reports serving on advisory boards and receiving consulting fees and honoraria from Merck, Pfizer, Abbott, Roche, Eli Lilly, and sanofi-aventis. Dr Kastelein reports serving as a consultant for Eli Lilly, Merck, Roche, Boehringer Ingelheim, Cerenis, Novartis, Genzyme, and Isis. Drs Krueger and Wang are employees of Eli Lilly. Dr Nissen reports receiving research support from AstraZeneca, Eli Lilly, Pfizer, Takeda, Sankyo, and sanofi-aventis. He has consulted for a number of pharmaceutical companies without financial compensation. All honoraria, consulting fees, or any other payments from any for-profit entity are paid directly to charity so that neither income nor any tax deduction is received. No other disclosures were reported.
Funding/Support: The study was funded by Eli Lilly.
Role of the Sponsor: Eli Lilly participated actively in designing the study, developing the protocol, and provided logistical support during the trial. Monitoring of the study was performed by a contract research organization, Quintiles, under contract with the sponsor. The sponsor maintained the trial database. Statistical analysis was performed by statisticians employed by Eli Lilly, although the analyses reported in the article represent those performed by the academic statisticians (Mr Shao and Dr Hu). After completion of the trial, as specified in the study contract, a complete copy of the database was transferred to the Cleveland Clinic Coordinating Center for Clinical Research, where analyses were verified by the independent statisticians, Mr Shao and Dr Hu. The manuscript was prepared by Dr Nicholls and modified after consultation with the coauthors. The sponsor was permitted to review the manuscript and suggest changes, but the final decision on content was exclusively retained by the academic authors.
Independent Statistical Analysis: For the purpose of the academic interpretation of the study, Mr Shao and Dr Hu performed all primary statistical analyses. All results presented in the article were performed by Dr Hu. Mr Shao is an employee of the Cleveland Clinic Coordinating Center for Clinical Research. Dr Hu is a faculty member within the Department of Quantitative Health Sciences at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University.
Study Investigators:Data and Safety Monitoring Board: James H. Stein, MD, University of Wisconsin, Madison (chair); George L. Bakris, MD, University of Chicago, Chicago, Illinois; Philip Barter, MD, director, the Heart Research Institute, Sydney, Australia; Pooja Khera, MD, Cleveland Clinic, Cleveland, Ohio; Carl Pepine, MD, University of Florida, Gainesville; Walter Offen, PhD, senior research fellow, Eli Lilly, Indianapolis, Indiana (nonvoting). Participating Investigators for Lilly EIAF: Denmark: CCBR A/S, Vejle (Peter Alexandersen, MD), CCBR A/S, Ballerup (Pernille Lundqvist, MD). Germany: ClinPharm International, Goerlitz, SN (Hartwin Berge, DrMed), Synexus ClinPharm, Leipzig, SN (Elizaveta Degtyareva, MS), Synexus ClinPharm, Berlin, BE (Janna Stoessel, MD), Synexus ClinPharm, Bochum, NW (Andrea Rinke, DrMed), Synexus ClinPharm, Dresden, SN (Hans-Detlev Stahl, DrMed). Netherlands: Andromed, Rotterdam (J. J. C. Jonker, MD), Andromed, Eindhoven (Lindy Diepenmaat, MD), Andromed, Breda (V. Köse, MD), Andromed, Leiden, Leiderdorp (I. Agous, MD), Andromed, Zoetermeer (Miente Everts, MD), Andromed, Oost, Velp (J. Hoogendijk, MD), Andromed, Groningen (Willem Van Kempen, MD), Academisch Medisch Centrum, Amsterdam (Mieke Trip, MD), PreCare Trial and Recruitment, Geleen (V. E. K. M. Van de Walle, MD). Poland: Synexus SCM, Wroclaw (Katarzyna Szymkowiak, MD), Centrum Leczenia Chorob, Warszawa (Magda Dabrowska, MD). United Kingdom: Synexus, Chorley (Ravi Pawa, MD), Synexus, Manchester (Irina Pavel-Knox, MD), Merseyside Clinical Research Centre, Liverpool (Essam Abdulhakim, FRCS, MS, MBChB), Synexus Midland Clinical Research Centre, Birmingham (Rex Sarmiento, MD), Synexus Scotland Clinical Research Centre, Glasgow (Rahul Ellahbadi, MD), Synexus, Reading (Hilary Shaw, MD), Synexus Wales Clinical Research Centre, Cardiff (Hawys Thomas, MD). United States: Jeffrey A. Lindebaum, DO, PC, Yardley, Pennsylvania (Patrick Adler, DO), Great Lakes Medical Research, Westfield, New York (Donald Brautigam, MD), Holston Medical Group, Bristol, Tennessee (Andrew Brockmyre, MD), Hillcrest Clinical Research, Simpsonville, South Carolina (Robert Broker, MD), New West Physicians Clinical Research, Golden, Colorado (Kenneth Cohen, MD), Anderson and Collins Clinical Research, Edison, New Jersey (Harry Collins, MD), Dairyland Medical Center, Red Lion, Pennsylvania (Drake DeHart, DO), Scripps Clinical Research, San Diego, California (Margaret Drehobl, MD), PMG Research of Hickory, Hickory, North Carolina (John Earl, MD), Endwell Family Physicians, Endwell, New York (Victor Elinoff, MD), Radiant Research, Greer, South Carolina (William Ellison, MD), the Research Group of Lexington, Lexington, Kentucky (Neil Farris, MD), Village Research, Houston, Texas (Harold Fields, MD), Mississippi Medical Research, Picayune, Mississippi (Ahmad Haidar, MD), PMG Research of Wilmington, Wilmington, North Carolina (Charles Herring, MD), Alan Hoffman, MD, Houston, Texas, Wichita Clinic, Wichita, Kansas (Kevin Hoppock, MD), Health Trends Research, Baltimore, Maryland (Boris Kerzner, MD), Jacksonville Center for Clinical Research, Jacksonville, Florida (Michael Koren, MD), Progressive Clinical Research, Vista, California (Jon LeLevier, MD), Encompass Clinical Research, Spring Valley, California (Robert Lipetz, DO), Pulmonary Associates of Brandon, Brandon, Florida (Daniel Lorch Jr, MD), PMG Research of Salisbury, Salisbury, North Carolina (Robert McNeill, MD), PMG Research of Charleston, Mt Pleasant, South Carolina (Richard Mills, MD), Family Practice, Stoneboro, Pennsylvania (Joseph Morelli, MD), American Health Network of Indiana, Indianapolis (Thomas Moretto, MD), Holston Medical Group, Kingsport, Tennessee (David Morin, MD), PharmQuest, Greensboro, North Carolina (Alexander Murray, MD), Dean Clinic Oregon, Oregon, Wisconsin (Zorba Paster, MD), Northeast Iowa Medical Education Foundation, Waterloo, Iowa (James Poock, MD), PMG Research of Bristol, Bristol, Tennessee (Stephanie Powell, MD), PMG Research of Charlotte, Charlotte, North Carolina (George Raad, MD), Radiant Research, Dallas, Texas (Michele Reynolds, MD), PMG Research of Raleigh, Raleigh, North Carolina (John Rubino, MD), Medical Associates of Northwest Arkansas, Fayetteville, Arkansas (James Salmon, MD), NorthWest Family and Spinal Clinic, Tacoma, Washington (Kenneth Scherbarth, DO), St Johns Center for Clinical Research, Ponte Vedra, Florida (Erich Schramm, MD), PMG Research of Wilmington, Wilmington, North Carolina (Jonathan Staub, MD), Genesis Research International, Longwood, Florida (Raul Tamayo, MD), PMG Research of Cary, Cary, North Carolina (Martin Van Cleeff, MD), Maine Research Associates, Auburn (Robert Weiss, MD), PMG Research of Winston-Salem, Winston-Salem, North Carolina (Jonathan Wilson, MD), Founders Research Corporation, Philadelphia, Pennsylvania (Gary Yeoman, DO).
Online-Only Material: The Author Video Interview is available here.