Acknowledgments and disclosures: The authors would like to thank all study personnel who participated in the study, especially the Principal Investigators: H. Baglivo, M. Bendersky, E. Kuschnir, P. Rodriguez, A. Villamil (Argentina); J. Felicio, P. Jardim, O. Kohlman, D. Mion Jr (Brazil); M. Alpizar, R. Alvarado, J. Illescas, A. Meaney, J. Parra, R. Peralta, I. Rodriguez, H. Sanchez, S. Trevethan (Mexico); D. Bernhardi, A. Briel, S. Chetty, E. Janari, J. Jurgens, C. Kahanowitz, D. Lakha, H. Makan, I. Mitha, P. Nel, P. Patel, Z. Vawda, N. Wellington, (South Africa); J. Agaiby, J. Anderson, G. Balaji, H. Bays, N. Bertini, W. Bestermann Jr, K. Blaze, A. Borge, J. Boscia III, T. Brobyn, J. Brodnan, V. Brown, T. Cavalieri, C. Chappel, A. Chen, D. Cheung, S. Christensen, S. Chrysant, C. Cooper, T. Copeland, C. De Busk, D. DeSantis, B. Douglas, J. Ervin, P. Fiacco, T. Fiel, J. George, L. Gilderman, R. Gilman, R. Glover III, A. Goetsch, R. Graf, A. Graff, M. Graves, J. Gutmann, C. Hall, W. Harper, D. Henry, H. Hidalgo Jr, J. Holland, D. Honeycutt, C. Johnson, A. Khan, B. Khan, P. Klaassen, M. Kozinn, S. Kreis, K. Layne, J. Lee, A. Lewin, C.-S. Liang, L. Ligon, T. Linder, R. Lipetz, M. Lucas, R. Marple, J. Meli, C. Mello, R. Middleton, S. Mion-Bet, K. Mootoo, A. Murray, J. Naidu, P. Narayan, J. Navarro, J. Neutel, A. Niederman, R. Noble, A. Patron, F. Phillips, W. Pleskow, H. Punzi, G. Raad, T. Raoof, P. Raskin, A. Razzetti, L. Reed, H. Resnick, J. Schmidt, R. Schreiman, D. Schumacher, M. Seidner, K. Self, G. Serfer, W. Shapiro, J. Silverfield, S. Slabic, R. Sockolov, J. Sparks, R. Struble, C. Thompson, P. Toth, T. Treimer, P. Vrooman, D. Webster, G. Willis, S. Willsie, D. Wright, S. Yates (USA). The authors would also like to thank Karen Shannon (Trial Data Manager, Boehringer Ingelheim), Steven Koval (Trial Statistician, Boehringer Ingelheim), and Ashish Singh (Director, Boehringer Ingelheim). Writing assistance was provided by PAREXEL MMS, and was funded by Boehringer Ingelheim. The work was funded and sponsored by an educational grant from Boehringer Ingelheim. M. Kobe is an employee of Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT.