Author Contributions: Drs Bakris and Bell had
full access to all of the data in the study and take responsibility for the
integrity of the data and the accuracy of the data analysis.
Study concept and design: Bakris, Oakes, Lukas,
Acquisition of data: Bakris, Katholi, McGill,
Messerli, Phillips, Raskin, Wright, Oakes, Anderson, Bell.
Analysis and interpretation of data: Bakris,
Fonseca, McGill, Messerli, Wright, Oakes, Lukas, Anderson, Bell.
Drafting of the manuscript: Bakris, Fonseca,
McGill, Messerli, Wright, Lukas, Anderson, Bell.
Critical revision of the manuscript for important
intellectual content: Bakris, Fonseca, Katholi, McGill, Messerli, Phillips,
Raskin, Wright, Oakes, Anderson, Bell.
Statistical analysis: Oakes, Anderson.
Obtained funding: Wright, Bell.
Administrative, technical, or material support:
Fonseca, Katholi, Phillips, Wright, Lukas.
Study supervision: Bakris, Wright, Anderson,
The GEMINI Investigators:Alabama: David S. H. Bell, MD, Alain Bouchard, MD, David A. Calhoun,
MD (Birmingham);Thomas M. Nolen, MD (Columbiana); Robert Israel, MD (Mobile); Arizona: Robert Siegel, MD (Gilbert), Richard Albery, MD,
Royal B. Anspach, MD, Marshall Block, MD, James V. Felicetta, MD, Richard
Heuser, MD, Rajul I. Patel, MD, Ernie Riffer, MD, Edward Tokatlian, MD, Kris
Vijay, MD (Phoenix), Paul Fenster, MD, Mark Goldberg, MD, David Johnson, MD,
Gregory Koshkarian, MD (Tucson); California: Dennis
Riff, MD (Anaheim), William Zigrang, MD (Burlingame), Jonathan Hemphill, MD
(Carmichael), Georges Argoud, MD (Chula Vista), Roy Kaplan, MD (Concord),
George Dennish, MD, James Quigley, DO (Encinitas), Malcolm Sperling, MD (Fountain
Valley), Betty Grant-Anderson, MD (Hemet), Sidney Rosenblatt, MD (Irvine),
Deanna Cheung, MD (Long Beach), Ken Chiu, MD, Andrew Lewin, MD (Los Angeles),
David Price, MD (Milpitis), Henry Sideropoulos, MD (Pasadena), Chiayu Chen,
MD (Riverside), Robert J. Doria, MD (San Luis Obispo), Robert Lipetz, DO (Spring
Valley), Stanley Rockson, MD (Stanford), Joel Neutel, MD (Tustin), Richard
Weinstein, MD (Walnut Creek); Colorado: Jennifer
Hone, MD (Arvada), Diana Dills, MD (Aurora), Jane Reusch, MD, Nampalli Vijay,
MD (Denver), Kenneth Cohen, MD, Debra Friesen, MD (Golden), Peter Smith, MD
(Loveland); Connecticut: Andrew Rashkow, MD (Derby),
William White, MD (Farmington), Arthur DeGraff, MD, Neil Grey, MD (Hartford),
James Bernene, MD (New Britain); Delaware: Walter
R. Powell, MD (Newark); District of Columbia: Judith
Hsia, MD, Vasilios Papademetriou, MD; Florida: Ester
Levin, MD, Jeffrey B. Rosen, MD (Coral Gables), John Rozanski, MD, Martin
Shansky, MD, Alan Graff, MD, Alan Niederman, MD (Ft. Lauderdale), Marvin Heuer,
MD (Gainesville), Michael Galinsky, MD, Sam Lerman, MD, Gregory Serfer, MD
(Hollywood), Peter Rossi, MD (Hudson), Rafik Abadier, MD (Inverness), Michael
Koren, MD, Mark Stich, MD (Jacksonville), Rajiv Chandra, MD, Gregory Waser,
MD (Melbourne), Alvaro Gomez, MD, Luigi Meneghini, MD, Julio Pita, MD, Richard
Preston, MD, Paul Seigel, MD, John Sokolowicz, MD (Miami), Robert McGhee,
DO, Larry R. Popeil, MD (Ocala), Misal Khan, MD (Panama City), Larry I. Gilderman,
MD (Pembroke Pines), Mahfouz El Shahawy, MD (Sarasota), Michael McIvor, MD,
Gregg Schuyler, MD (St. Petersburg), Ricky Schneider, MD (Tamarac), Edward
Braun, MD, Jesus Navarro, MD (Tampa); Georgia: Stephen
Broadwater, MD (Augusta), Frank Cole, MD (Fayetteville), Sreeni Gangasani,
MD (Lawrenceville), Paul Bradley, MD (Savannah); Hawaii: Richard Arakaki, MD (Ewa Beach), Patricia Blanchette, MD, David Fitzpatrick,
MD (Honolulu); Idaho: Terry Riske, MD (Hayden Lake), John Liljenquist, MD,
Herbert Moskow, MD (Idaho Falls); Illinois: Steven
Harnack, MD (Aurora), George L. Bakris, MD, Peter Lee, MD, John Sobolski,
MD, Danny Sugimoto, MD (Chicago), Dennis Abella, MD (Elk Grove Village), Jeffrey
G. Shanes, MD (Melrose Park), Bradley Sakran, MD (O'Fallon), Richard
E. Katholi, MD (Springfield), Shahriar Dadkhah, MD, (West Evanston); Indiana: George Mark, MD (Elkhart), Andrew Thieneman, MD
(Evansville), Phillip Toth, MD (Indianapolis), Gary Erdy, MD (Newburgh), James
McCann, MD (Wabash); Iowa: Nancy Kane-Johnson, MD,
Gregory Peterson, MD (Des Moines), Helmut Schrott, MD (Iowa City); Kentucky: Tadarro Richardson, MD (Lexington); Louisiana: Peter Abel, MD (Morgan City), Vivian Fonseca, MD, Franz Messerli,
MD (New Orleans); Maine: Robert J. Weiss, MD (Auburn),
Mark Henderson, MD (Bangor); Maryland: James Mersey,
MD (Baltimore), Boris Kerzner, MD (Pikesville); Massachusetts: Terrance Hack, MD (Ayer), Paul Conlin, MD (Boston), Michael J. McCartney,
MD (Salisbury), Adnan Dahdul, MD (Springfield), Eddward Busick, MD (Waltham),
Jayashri Aragam, MD (West Boylston), Charles Birbara, MD (Worcester); Michigan: Mohammad Nadeemullah, MD, Amy Rothberg, MD, Martin
Stevens, MD (Ann Arbor), Marcus J. Zervos, MD (Birmingham), Gary Ruoff, MD
(Kalamazoo), Pramod Raval, MD (Oak Park), Irvin Gastman, MD (Waterford); Minnesota: Norman Lunde, MD (Arden Hills), Bonita L. Hill,
MD (Chaska), C. Rowen DeBold, MD, Jordan L. Holtzman, MD (Minneapolis), Alan
Bank, MD (St. Paul); Mississippi: Stanford Owen,
MD (Gulfport); Missouri: Thomas Crouch, MD, William
L. Isley, MD, Sandra Willsie, DO (Kansas City), Mark Entrup, DO (Springfie
Funding/Support: This study was funded by GlaxoSmithKline
Pharmaceuticals. Dr Fonseca is supported in part by a National Institutes
of Health grant 5M01RR05096 from the Division of Research Resources.
Role of the Sponsor: GlaxoSmithKline participated
in discussions regarding study design and protocol development and provided
logistical support during the trial. Monitoring of the study was performed
by a contract research organization, under contract with GlaxoSmithKline,
who maintained the trial database. After completion of the study, a complete
copy of the database was transferred to Rush University Medical Center. Primary
statistical analysis was performed by GlaxoSmithKline but verified independently
by the Statistics Section of the Department of Preventive Medicine at Rush
University. The manuscript was prepared by the first and corresponding authors
and they modified the manuscript after consultation with the other authors.
GlaxoSmithKline was permitted to review the manuscript and suggest changes
but the final decision on content was exclusively retained by the authors.
Acknowledgment: We thank the GEMINI investigators
for their time and commitment to the trial. We acknowledge the contributions
made by Sanjib Basu, PhD, visiting Associate Professor, Rush University, and
Associate Professor, Northern Illinois University, who performed an independent
statistical analysis that confirmed the main results.