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Margareth C. Ozelo, M.D., Ph.D., Johnny Mahlangu, M.B., B.Ch., M.Med., K. John Pasi, M.D., Ph.D., Adam Giermasz, M.D., Ph.D., Andrew D. Leavitt, M.D., Michael Laffan, M.D., Ph.D., Emily Symington, M.D., Doris V. Quon, M.D., Ph.D., Jiaan-Der Wang, M.D., Ph.D., Kathelijne Peerlinck, M.D., Ph.D., Steven W. Pipe, M.D., Bella Madan, M.D., Nigel S. Key, M.D., Glenn F. Pierce, M.D., Ph.D., Brian O’Mahony, F.A.C.S.L.M., Radoslaw Kaczmarek, Ph.D., Joshua Henshaw, Ph.D., Adebayo Lawal, M.D., Kala Jayaram, M.D., Mei Huang, M.S., Xinqun Yang, Ph.D., Wing Y. Wong, M.D., and Benjamin Kim, M.D. for the GENEr8-1 Trial Group*