Study concept and design: Fain, Alexander.
Acquisition of data: Fain, Daubresse.
Analysis and interpretation of data: Fain, Daubresse, Alexander.
Drafting of the manuscript: Fain, Daubresse.
Critical revision of the manuscript for important intellectual content: Fain, Daubresse, Alexander.
Statistical analysis: Fain.
Obtained funding: Alexander.
Administrative, technical, or material support: Daubresse.
Study supervision: Fain, Alexander.
Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Mr Fain reported working in the Office of Chief Counsel at the US Food and Drug Administration (FDA) from 1995 until 2010. Dr Alexander reported being an ad hoc member of the FDA’s Drug Safety and Risk Management Advisory Committee; serving as a paid consultant to IMS Health; and serving 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). Mr Daubresse did not report any disclosures.
Funding/Support: Dr Alexander is supported by grant RO1 HS0189960 from the Agency for Healthcare Research and Quality.
Role of the Sponsor: The funding source had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.