1 Office of Surveillance and Epidemiology, Center for Drug Evaulation and Research, Food and Drug Administration, Silver Spring, Maryland, USA efe.eworuke@fda.hhs.gov.
2 Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
3 Office of Surveillance and Epidemiology, Center for Drug Evaulation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.