CAMUS Study Group: Steering Committee Chair, Massachusetts General Hospital, Michael J. Barry, MD; Data Coordinating Center, University of Alabama at Birmingham, O. Dale Williams, PhD (Director), Sreeletha Meleth, PhD (Associate Director), Lisa R. Allen.
Clinical Sites: New York University—Andrew McCullough, MD (PI), Brianne Goodwin, BSN, RN (Study Coordinator), Laurie Mantor (Study Coordinator), Artrit Butuci (Research Data Associate); Northern California Kaiser Permanente—Andrew L. Avins, MD, MPH (PI), Harley Goldberg, DO (Co-I), Luisa Hamilton (Study Coordinator); Northwestern University Finberg School of Medicine—Kevin T. McVary, MD (PI), Robert Brannigan, MD (Co-I), Brian Helfand, MD, PhD (Consultant), Maria Velez (Study Coordinator), Nancy Schoenecker, RN, CCRC (Clinical Research Coordinator); Queens University—J. Curtis Nickel, MD (PI), Alvaro Morales (Co-I), D. Robert Siemens, MD (Co-I), Joe Downey, MSc, CCRP (Study Coordinator), Janet Clark-Pereira, CCRP (Study Coordinator); University of Colorado Denver—E. David Crawford, MD (PI), Shandra S. Wilson, MD (Co-I), Paul D. Maroni, MD (Co-I), Patricia DeVore, BS (Clinical Research Coordinator), Cliff Jones (Clinical Research Coordinator); University of Iowa—Karl J. Kreder, MD, MBA (PI), Victoria Sharp, MD, MBA (Co-I), Diane Meyerholz, RN, BSN (Study Coordinator), Mary Eno, RN (Study Coordinator); University of Maryland—Michael J. Naslund, MD (PI), Ganine Markowitz-Chrystal, MS, CCRC (Study Coordinator); University of Texas, Southwestern Medical Center—Claus G. Roehrborn, MD (PI), Brad Hornberger, PA-C (Co-I), Allison Beaver, RN (Study Coordinator), Suzie Carter (Data Manager); Washington University School of Medicine—Gerald L. Andriole, MD (PI), Vivien Gardner, RN, BSN (Study Coordinator), Karen Whitmore (Supervisor Patient Services); Weill Cornell Medical College—Steven A. Kaplan, MD (PI), Alexis E. Te, MD (Co-I), Noreen Buckley, NP, CCRC (Study Coordinator), Maritza Rodriquez (Medical Assistant); Yale University School of Medicine—Harris E. Foster, Jr., MD (PI), John W. Colberg, MD (Co-I), Karen Stavris, RN MSN, CCRC (Study Coordinator).
Biostatistics Consultant: University of Arkansas for Medical Sciences, Jeannette Y. Lee, PhD.
Data Safety Monitoring Board: University of Minnesota VA Medical Center, Timothy J. Wilt, MD, MPH (Chair); University of Illinois at Chicago, Harry H.S. Fong, PhD; University of Chicago, Glenn S. Gerber, MD; University of Virginia, Mikel Gray, RN, PhD, CUNP, FAAN; HeteroGeneity LLC, Freddie Ann Hoffman, MD; University of North Carolina, Gary Koch, PhD; University of California at Los Angeles, Mark Litwin, MD, MPH; US Environmental Protection Agency, Warren E. Lux, MD; Harvard Medical School, Michael P. O'Leary, MD, MPH; Alliance for Prevention of Prostate Cancer, Col (Ret.) James E. Williams, Jr.; Hines VA Hospital CSPCC, Domenic Reda, PhD.
Sponsor, supplier of Saw palmetto fruit extract: Rottapharm/Madaus, Joseph J. Veilleux, RPH, MBA.
Sponsors: National Institutes of Health (NIH); National Institute of Diabetes, Digestive & Kidney Diseases, John W. Kusek, PhD; National Center for Complementary and Alternative Medicine, Catherine M. Meyers, MD, Sheila Caldwell, PhD; Office of Dietary Supplements, Joseph M. Betz, PhD, Paul M. Coates, PhD.
MTOPS Database: The MTOPS study was conducted by the MTOPS investigator and supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The manuscript was not prepared in collaboration with the MTOPS investigators and does not necessarily reflect the opinions or view of the MTOPS study of the NIDDK.
Support: CAMUS is funded by cooperative agreements from the National Institute of Diabetes and Digestive and Kidney Diseases: U01 DK63795, U01 DK63797, U01 DK63835, U01 DK63866, U01 DK63833, U01 DK63862, U01 DK63840, U01 DK63831, U01 DK63825, U01 DK 63883, U01 DK63778, and U01 DK63788. Support was provided by the National Center for Complementary and Alternative Medicine and the Office of Dietary Supplements, NIH. Saw palmetto fruit extract and matching placebo was supplied by Rottapharm/Madaus.