Author Contributions: Dr Pham-Kanter had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Pham-Kanter. Acquisition of data: Pham-Kanter and Nair. Analysis and interpretation of data: Pham-Kanter, Alexander, and Nair. Drafting of the manuscript: Pham-Kanter, Alexander, and Nair. Critical revision of the manuscript for important intellectual content: Pham-Kanter, Alexander, and Nair. Statistical analysis: Pham-Kanter. Obtained funding: Pham-Kanter, Alexander, and Nair. Administrative, technical, and material support: Pham-Kanter and Nair. Study supervision: Pham-Kanter and Nair.
Financial Disclosure: Dr Alexander is a consultant for IMS Health and has served as an ad hoc member of the US FDA's Drug Safety and Risk Management Advisory Committee. Dr Nair is a consultant for Janssen Services.
Funding/Support: This research was supported by the Edmond J. Safra Center for Ethics at Harvard University. Dr Alexander is supported by awards from the Agency for Healthcare Research and Quality (R01 HS0189960) and the National Heart, Lung, and Blood Institute (R01 HL 107345-01).
Role of the Sponsors: The funding sources had no role in the design and conduct of the study; analysis or interpretation of the data; or preparation or final approval of the manuscript prior to publication.
Disclaimer: The contents of and opinions expressed in this report are solely the responsibility of the authors and do not necessarily represent the official views of the funders.
Additional Contributions: Richard Read Allen, MS, Igor Gorlach, BA, Matthew Lemieux, and Grace Njau, BS, acquired some of the data required for the analysis. We wish to acknowledge input from members of the Research Ethics Program of Harvard Catalyst, the Harvard Clinical and Translational Science Center (NIH Award UL1 RR 025758 and financial contributions from Harvard University and its affiliated academic health care centers).