1 Division of Clinical Pharmacology 3, Office of Clinical Pharmacology, Office of Translational Sciences, Center of Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA.
2 Division of Biostatistics 3, Office of Biostatistics, Office of Translational Sciences, Center of Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA.
3 Division of Bone, Reproductive, and Urologic Products, Office of New Drugs, Center of Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA.
4 Division of Clinical Pharmacology 3, Office of Clinical Pharmacology, Office of Translational Sciences, Center of Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA. Electronic address: chongwoo.yu@fda.hhs.gov.