1. From the Office of Pediatric Therapeutics, Office of the Commissioner (D.K.B., P.B.S., M.D.M., J.S.L.), and Pharmacometrics, Office of Clinical Pharmacology, Center for Drug Evaluation and Research (P.J. and J.V.G.), US Food and Drug Administration, Rockville, MD; and the Departments of Pediatrics, Biostatistics, and Medicine and Duke Clinical Research Institute (D.K.B., P.B.S., V.H., C.B-S., and J.S.L.), and Duke Translational Medicine Institute (R.M.C.), Duke University, Durham, NC.