Author Contributions: Dr Pradhan 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: Pradhan, Cook, Ridker.
Acquisition of data: Pradhan, Everett, Rifai, Ridker.
Analysis and interpretation of data: Pradhan, Everett, Cook, Ridker.
Drafting of the manuscript: Pradhan, Ridker.
Critical revision of the manuscript for important intellectual content: Pradhan, Everett, Cook, Rifai, Ridker.
Statistical analysis: Pradhan, Cook.
Obtained funding: Ridker.
Administrative, technical, or material support: Pradhan, Everett, Rifai, Ridker.
Study supervision: Pradhan, Ridker.
Financial Disclosures: During the period of this project, Dr Pradhan reported receiving research support from Sanofi-Aventis. Dr Ridker reported having received investigator-initiated research grant support from the National Heart, Lung, and Blood Institute; the National Cancer Institute; the Donald W. Reynolds Foundation; the Leducq Foundation; Astra-Zeneca; Novartis; Merck; Abbott; Roche; and Sanofi-Aventis; having received consulting fees or lecture fees from Astra-Zeneca, Novartis, Merck, Merck-Schering Plough, Sanofi-Aventis, ISIS, Dade-Behring, and Vascular Biogenics; and being listed as a coinventor on patents held by the Brigham and Women's Hospital that relate to the use of inflammatory biomarkers in cardiovascular disease and diabetes. These patents have been licensed to Siemens and Astra-Zeneca. No other disclosures were reported.
Funding/Support: LANCET was an investigator-initiated trial funded by Sanofi-Aventis.
Role of the Sponsor: The funder had no role in the design and conduct of the study; in the collection, analysis, and interpretation of the data; or in the preparation, review, or approval of the manuscript.
Additional Contributions: We thank the 500 study participants and also acknowledge the tireless efforts of the LANCET Coordinating Center (Brigham and Women's Hospital) study staff without whom this study would not have been possible, including David Bates, BS; Gail Borkowski, BA; Ellie Danielson, MIA; Georgina Friedenberg, MPH; Vincent Guzman; Nitsan Halevy, MD; Catherine Lapsley, BA; Tony Laurinaitis; Jean MacFadyen, BA; Annie Murray; Harriet Samuelson, MA; Daphne Suzin, BA, BS; Elaine Zaharris, BA; as well as the dedicated laboratory personnel at the Clinical and Epidemiologic Research Laboratory, Boston Children's Hospital, including Gary Bradwin, BS; Shaké Ayanian, BS; Nathalie Bitar, BS; Susan Bradwin, CLA(ASCP); Eileen Brennan, BS; Genevieve Briones, MPH; Terry Law, BS; Anthony Ricupero, BS; and Emma Tzioumis, BS. Data and safety monitoring board members for the LANCET trial were as follows: Paul R. Conlin, MD (VA Boston Healthcare System, Brigham and Women's Hospital, Harvard Medical School); Jose C. Florez, MD, PhD (Massachusetts General Hospital, Broad Institute, Harvard Medical School); and Allison B. Goldfine, MD (Joslin Clinic, Harvard Medical School). Members of the data and safety monitoring board were compensated for time and effort related to data and safety monitoring for the trial.
LANCET Investigators: Listed are the site Principal Investigator, site Study Coordinator, and location, with number of participants randomized indicated in parentheses: C. Kent, S. Baker (50), Quincy, FL; C. Pinner, P. Bowers (24), Peak, SC; R. Chandra, M. Johnston (23), Lexington, MO; S. Moussa, H. Beltz (23), Whitehall, PA; N. Doyle, M. Dail (22), Wilson, NC; R. L. Murphy, D. Murphy, P. Goodrich (22), Humboldt, TN; J. Howard, J. Brosius (17), Charlotte, NC; A. Rudo, S. Holmes, K. Kennedy (17), Westminster, MD; G. Platt, J. Q. Love, C. Thomason (15), Green Cove Springs, FL; J. Rybicki, A. Rybicki, B. Marquinhos (14), Philadelphia, PA; S. Patel, J. Severs (13), Irvington, KY; E. Ranasinghe, T. Seneviratne, D. Williams (12), Shaker Heights, OH; R. Grimball, L. Woods, B. Williamson (11), Sulphur, LA; P. McLaughlin, F. McLaughlin (11), Mount Sterling, KY; L. C. Atwood, A. Bryant (10), Independence, KS; R. Cole, A. Cole (10), Stuart, VA; D. Whitt, M. Hammer (10), Pickerington, OH; P. McCaffrey, D. Duran (8), Pueblo, CO; S. Schwartz, C. Sheets (8), San Antonio, TX; M. Souza, S. Lobo, A. Carvalho (8), East Providence, RI; J. Bonelli, M. Saldana (7), Silver Spring, MD; S. Chooljian, K. Chooljian (7), Fresno, CA; H. Mariano, M. Espiritu, L. Protacio (7), Fresno, CA; D. Rivas, J. Lopez (7), Tampa, FL; M. Waseem, L. Hudnet, M. Grammer (7), Baltimore, MD; J. Guerrero, A. Salazar (6), Houston, TX; S. Kulback, C. Honeycutt (6), Birmingham, AL; A. Smith, C. Bencko (6), Adamsville, AL; B. Collins, A. Dupree, L. Bunn, B. Capps, A. DeFreese (5), Pell City, AL; L. Handke, J. Supencheck (5), Lincoln, NE; J. Herrod, L. Noll, M. Duron (5), Sierra Vista, AZ, T.-S. Lee, T. Pacos (5), Dunkirk, NY; B. McCracken (5), Greenville, IL; W. McGarity, J. Waller (5), Decatur, GA; J. Almand, S. Singh (4), Grand Prairie, TX; C. Chappel, T. Koenig (4), Kissimmee, FL; R. McDavid, K. Phillips, T. Robbins (4), Johnson City, TN; S. Ross, A. Coleburn (4), Florence, SC; Z. Adefuin, A. Luciano, H. Ferrillo-Dilulio (3), Bridgeport, CT; S. Adkins, M. Perry, R. Phillips (3), Weber City, VA; W. Brown, D. J. Bolesta (3), Thorndale, PA; K. Christensen, T. Boomgaarden (3), Idaho Falls, ID; K. Eaton, B. Cody (3), Dothan, AL; B. Frandsen, L. Bitz (3), Port Orchard, WA; D. Gandhi, V. Gandhi (3), Hartselle, AL; H. Mariano, G. Cruz, A. Francisco, S. Go (3), Anaheim, CA; T. Milko, C. Goodwin (3), Graysville, AL; M. Mudrick, H. Mudrick (3), Chester, PA; T. Rouse, M. Palmer (3), Saranac, MI; J. Scheuer Jr, J. Baldwin (3), Camden, SC; L. Curry, H. Helman, L. Chamberlin, K. Ford (2), South Bend, IN; J. Delgado, K. Andrus (2), Ashland, OR; M. Gandhi, M. Gandhi, R. Smith (2), Woodruff, SC; M. Harless, F. C. Bell (2), Hartsville, SC; S. Lewis, S. Lisovskiy (2), Concord, CA; J. Morelli, M. Whitehouse (2), Stoneboro, PA; E. A. Osea, A. Francisco, A. Aquino, E. Heredia (2), Harbor City, CA; J. Weil, D. S. Patel, K. Davies (2), Las Vegas, NV; J. Perez, S. Revels, J. Bryant (2), Sarasota, FL; G. Portnay, L. Brazee (2), Billerica, MA; K. Pritchett, M. Reno, M. Murray, L. Methvin (2), O’Fallon, IL; P. Punjabi, J. Amill (2), Feasterville, PA; D. Shrestha, R. Ferguson (2), Bay City, MI; N. Tuanquin, T. Tuanquin (2), Logan, WV; P. Barrington, K. Turner (1), Snellville, GA; J. Cuellar, C. Sitton (1), Wentzville, MO; I. Fenton, P. Finch (1), Vernon Hills, IL; K. Hershon, S. Goon, R. Moskowitz, (1), New Hyde Park, NY; J. Katsetos, P. Silvia (1), Milford, CT; D. Kenton, R. Zambrana (1), Deerfield Beach, FL; L. Kuskin, S. Gifford (1), Harrisburg, PA; J. Marshall (1), Hoover, AL; M. Samson, R. Blasco (1), Buena Park, CA.