Declaration of interest
Debra Luffer-Atlas is a full-time employee of Eli Lilly & Co. Aisar Atrakchi is a full-time employee of the U.S. Food and Drug Administration. The views and opinions expressed in this document are solely those of the authors and are not the official policy of the FDA. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.