1 U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Office of Rare Diseases, Pediatrics, Urologic, and Reproductive Medicine, Division of Urology, Obstetrics and Gynecology, Silver Spring, Maryland.
2 U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology, Office of Pharmacovigilance and Epidemiology, Division of Pharmacovigilance II, Silver Spring, Maryland.