Affiliation: | 1. Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland;2. Division of Clinical Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland;3. Division of Pulmonary, Allergy, and Rheumatology Products, Office of Drug Evaluation, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland |