Study concept and design: All authors.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Schmid, Burcu.
Critical revision of the manuscript for important intellectual content: All authors.
Administrative, technical, or material support: All authors.
Study supervision: Zito.
Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.
Funding/Support: This study was funded by the US Food and Drug Administration (FDA). Mr Schmid was supported in part by a fellowship administered by the Oak Ridge Institute for Science and Education and funded by the US FDA.
Role of the Funder/Sponsor: The FDA had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation of the manuscript; and decision to submit the manuscript for publication. The FDA did participate in the review and approval of the manuscript; however, the study authors functioned as investigators without direction or interference by the FDA.
Disclaimer: The opinions expressed in this research letter are those of the authors and do not necessarily represent the opinions of the US government or the FDA.