*Department of Epidemiology
†Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg School of Public Health
‡Division of General Internal Medicine, Johns Hopkins Medicine, Baltimore, MD
G.C.A. is supported by the Agency for Healthcare Research and Quality (RO1 HS0189960) and the National Heart, Lung and Blood Institute (R01 HL107345). K.M.F. is supported as a Sommer Scholar at the Johns Hopkins Bloomberg School of Public Health. The funding sources had no role in the design and conduct of the study, analysis, or interpretation of the data and preparation or final approval of the manuscript before publication.
K.M.F. worked in the Office of Chief Counsel at the US Food and Drug Administration from 1995 until 2010. G.C.A. is an ad hoc member of the FDA’s Drug Safety and Risk Management Advisory Committee, serves as a paid consultant to IMS Health, and serves on an IMS Health scientific advisory board. This arrangement has been reviewed and approved by Johns Hopkins University in accordance with its conflict of interest policies.
Reprints: Kevin M. Fain, JD, MPH, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street W6508, Baltimore, MD 21205. E-mail: firstname.lastname@example.org.