1 Division of Bone, Reproductive, and Urologic Products, Office of Drug Evaluation III, Office of New Drugs, U.S. Food and Drug Administration, Silver Spring, Maryland.
2 Division of Pharmacovigilance II, Office of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology and Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.