Author Contribution: Mr Chow and Ms Shamayeva 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: Zacharski, Chow, Howes, Baron, Dalman, Malenka, Ozaki, Lavori.
Acquisition of data: Zacharski, Chow, Howes, Shamayeva, Dalman, Ozaki.
Analysis and interpretation of data: Zacharski, Chow, Howes, Shamayeva, Baron, Dalman, Malenka, Ozaki, Lavori.
Drafting of the manuscript: Zacharski, Chow, Lavori.
Critical revision of the manuscript for important intellectual content; Zacharski, Chow, Howes, Shamayeva, Baron, Dalman, Malenka, Ozaki, Lavori.
Statistical analysis: Chow, Shamayeva, Lavori.
Obtained funding: Zacharski, Chow, Howes, Lavori.
Administrative, technical and material support: Zacharski, Chow, Howes, Shamayeva, Lavori.
Study supervision: Zacharski, Chow, Howes, Shamayeva, Baron, Dalman, Malenka, Ozaki, Lavori.
Financial Disclosures: None reported.
VA Cooperative Study #410 Personnel and Centers:Study Chairman's Office: Leo R. Zacharski, MD (Study Chairman), Paula Howes, MS, APRN (National Study Coordinator), M Heath. Executive Committee: L. R. Zacharski, MD (Chairman), B. K. Chow, P. Howes, C. K. Ozaki, MD, R. L. Dalman, MD, J. A. Baron, MD, D. L. Makenka, MD. Data and Safety Monitoring Board: B. Massie, MD (Chairman), P. Carson, MD, T. Colton, PhD, K. Detre, PhD, M. Gaziano, MD, S. Gottlieb, MD. Endpoints Adjudication Committee: J. F. Plehn, MD (Chairman), M. D. Tischler, MD, P. S. Rahko, MD, D. C. Hess, MD, T. J. DeGraba, MD, L. C. Pettigrew, MD. National Human Rights Committee: C. Giese (Chairperson). The Palo Alto Cooperative Studies Program Coordinating Center: P. Lavori, B. Chow, G. Shamayeva, L. Planting, L. Sheridan, B. Ventura. Participating VA Medical Centers (listed in descending order of the number of patients enrolled): Little Rock, Ark (M. Moursi, C. McDonald, J. Englehart, D. Doggett); Madison, Wis (J. Hoch, J. Burks, B. Dunlap); Houston, Tex (A. Blaustein, C. Pellegrino, C. Rowe, L. Lacy, R. Scott); Gainesville, Fla (C.K. Ozaki, A. Irwin, P. Irwin); Reno, Nev (R. DePalma, H.T. Cafferata, P. May, V. Hayes, K. Solomon, F. McKeon); Pittsburgh, Pa (M. Amidi, A. Sonel, M. Bell, J. Moorhead, M. DiTommas); Leavenworth, Kan (D. Courtney, M. Cook, J. Moppin); Long Beach, Calif (I. Gordon, L. Willis, W. Wong, K. Zalecki, D. Guizado, E. Berry, J. Ng); Hines, Ill (J. Third, A. White, J. Azolin, M. Ryan, A. Zuluaga, A. Vondruska); Palo Alto, Calif (R.L. Dalman, A. Hoffman, S. Thunen, S. Marinos, D. Yu); White River Junction, Vt (R.J. Powell, D. Balestra, D. O’Rourke, E. Belles, P. Howes); Louisville, Ky (S. Wagner, K. Doeshuk, M. Olligus, M. Alshaher, T. Abdul-Baki); Salt Lake City, Utah (S. Galt, M. Elstad, G. Treiman, L. Bhiranghi, C. Korowski, M. Jalilvand, D. Jost, S. Hatton-Ward, S. Granger); Lexington, Ky (T. Schwarcz, E. Endean, N. Lewis, J. Warner-Carpenter, P. Rowan, B. Broughton); San Juan, Puerto Rico (L.R. Ospina, J. Santos, A. Deleon, C. Pedrosa); Milwaukee, Wis (R. Cambria, G. Seabrook, A. Scott, S. Framberg, C. Kallio); Boston, Mass (W. Johnson, M. Watkins, J. Hamilton, A. Wrobel, B. Dionian), Durham, NC (J. Gray, C. Peterson, N. Lee, K. Swails); Cleveland, Ohio (S. Busuttil, J. Jean-Claude, D. Fox, K. Kallen, J. Miklacic, R. Jones, L. Tucker); Providence, RI (J. Slaiby, N. Crandell, L. Marquis, M.J. Roy); Birmingham, Ala (D. Whitley, L. Adams, J. Bailey-Griffin, J. Poirier, M. Egan, K. Mitchell, C. Inman); New York, NY (S. Sedlis, R. Burris, M. May, E. Anteola, M. Keary); West Haven, Conn (B. Sumpio, B. Borromeo, A. Dardick); Indianapolis, Ind (D. Cikrit, B. Solooki, C. Adams).
Funding/Support: This study was funded by the Cooperative Studies Program of the Department of Veterans Affairs Office of Research and Development, Clinical Science Research & Development Service.
Role of the Sponsor: The funding agency provided general policies and guidelines for conducting the study in accordance with federal and relevant regulations. The agency had no role in the study design, data collection, or analyses. This manuscript follows publication policies established by the funding agency.
Acknowledgment: We thank the members of the study group, data and safety monitoring board, and endpoints adjudication committee for their commitment to the study.