Funding for this research was provided by:
U.S. Food and Drug Administration (1U01FD006927-01)
Received: 16 June 2022
Accepted: 5 September 2022
First Online: 23 September 2022
: The authors declare that they have no conflict of interest.
: This article reflects the views of the authors and should not be construed to represent FDA’s views or policies.